Mhra Field Safety Notice: Medtronic Infusion Sets (specific Lot Numbers)
MHRA Field Safety Notice: Medtronic Infusion sets (specific lot numbers) Medtronic MiniMed Infusion Sets Recall of Specific Lot Numbers Medtronic voluntarily recalled specific lots earlier this month. Every Medtronic pump users should have been contacted by now. Medtronic MiniMed Quick-set (MMT-394, 384, 399, 387, 398, 397, 386, 396) Medtronic MiniMed Silhouette (MMT-377, 378, 384, 368, 381, 382, 383) Medtronic MiniMed Sure-T (MMT-862, 862T, 864, 866, 874, 876, 884, 886) Medtronic MiniMed Mio (MMT-921, 923, 925, 941, 943, 945, 961, 963, 965, 975) Patients are asked to go to www.mmc.medtronic-diabetes.com/look and determine if they are using recalled infusions sets. The website will prompt them to enter the REF and LOT numbers for all infusion sets in their possession. The website will tell them which infusion sets are part of this recall and which are not. Patients are asked not to use any recalled infusion sets, but to discard them. Medtronic will replace the recalled infusion sets free of charge. Continue reading >>
Federal Contract Opportunity: 761-medtronic-minimed Supplies (reservoir/infusion Sets) Veterans Healthcare Supply Solutions (vhss) 761-a50, Updated Sep 17, 2015
This MODIFICATION to this procurement request VA770-15-Q0312_2 is for the correction to the QTY Line Item#2 (as specified below) for the BRAND NAME/BRAND SPECIFIC Insulin Pump supplies for the Chelmsford, MA CMOP. MINIMED PARADIGM INFUSION PUMP, 3ML RESERVOIR MININMED QUICK-SET INFUSION SET (6mm Cannula 32") The Department of Veterans Affairs NETWORK Contracting Office 15 is seeking potential sources for the purchase of the BRAND NAME/BRAND SPECIFIC Med-Surg items for the Location: Department of Veterans Affairs, VA CMOP Chelmsford - 761 10 Industrial Ave Chelmsford, MA 01824-3610. THIS IS AN EMERGENCY REQUEST AND REQUIRES THE DELIVERY LEAD TIME TO BE NO LATER THAN 5 DAYS ARO. " The Department of Veterans Affairs, NCO 15, is intending to award a Commercial Purchase Order for the BRAND NAME/BRAND SPECIFIC Med-Surg items as specified above. " The RFQ# VA770-15-Q-0312 shall be posted thru FedBizOpps on or around September 15, 2015 and will close no later than 1630 CST on September 21, 2015. Responses must be concise and be specifically directed to the requirement reference above. All responsible open market sources may submit a quotation in a timely manner and shall be considered by this agency. All offers for this RFQ request must be submitted to the Contracting Specialist Jennie McCullough via email at [email protected] It is the offeror's responsibility to monitor FedBizOpps for changes or amendments. " This Solicitation has the possibility resulting in Multiple Awards. Continue reading >>
Recall: Medtronic Minimed Paradigm Insulin Infusion Sets
Recall: Medtronic MiniMed Paradigm Insulin Infusion Sets Recall: Medtronic MiniMed Paradigm Insulin Infusion Sets Product Description Medtronic MiniMed Paradigm Insulin Infusion Sets The Paradigm infusion sets are intended for use with Paradigm insulin infusion pumps. Code Info This field correction involves models: MMT-317, MMT-318, MMT-324, MMT-325, MMT-312S, MMT-312L, MMT-386, MMT-387, MMT-394, MMT-396, MMT-397, MMT-398, MMT-399, MMT-377, MMT-378, MMT-381, MMT-382, MMT-383, MMT-384, MMT-368, MMT-862, MMT-864, MMT-866, MMT-874, MMT-876, MMT-884, MMT-886, MMT-921, MMT-923, MMT-925, MMT-941, MMT-943, MMT-945, MMT-961, MMT-963, MMT-965, & MMT-975 Paradigm Infusion sets. Product Distributed Qty 11,000,000 units Reason For Recall Medtronic is recalling the Medtronic MiniMed Paradigm Insulin Infusion sets because of a potential safety issue that can occur if insulin or other fluids come in contact with the inside of Medtronic Paradigm infusion sets. Under certain conditions, the infusion set may malfunction and deliver an incorrect volume of insulin Continue reading >>
Medtronic Insulin Pump
Beginning in April 2013, the Medtronic Paradigm Insulin Pump has been the subject of a number of medical device safety alerts and recalls issued by its manufacturer and the U.S. Food and Drug Administration (FDA). The most serious of these notices include recalls of Medtronic MiniMed Paradigm Insulin Infusion Sets and Infusion Set Reservoirs. The week of April 17, 2013, the FDA issued a Class II recall of the Medtronic MiniMed Paradigm Insulin Infusion Pump, intended for use to deliver insulin to people with diabetes. Medtronic recalled the pumps because the pumps drive support cap may become detached from the pump case and protrude from the lower right side of the pump. When the pump is exposed to water, it may result in damage to the pumps internal electronics, which can prevent the pumps buttons from working properly or can cause the pump to alarm. Model numbers affected by this recall include: MMT-511, MMT-512, MMT-712, MMT-712E, MMT-515, MMT-715, MMT-522, MMT-522K, MMT-722, MMT-722K, MMT-523, MMT-523K, MMT-723, MMT-723K, MMT-554, and MMT-754. The recall includes about 428,000 units distributed worldwide. On June 7, 2013, the FDA issued a Class I Recall on Medtronic MiniMed Paradigm Infusion Sets. A Class I recall is the most serious type of recall and involves situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death. If insulin or other fluids come in contact with the inside of the tubing connector, it can temporarily block the vents that allow the pump to properly prime. If the pumps vents are blocked, this can potentially result in too much or too little insulin being delivered, which may cause hypoglycemia or hyperglycemia. In extreme cases, these conditions may cause loss of consci Continue reading >>
Important Information For Medtronic Paradigm Insulin Pump Users
Important Information for Medtronic Paradigm Insulin Pump Users Paradigm Insulin Pump users have an Urgent Medical Device Safety Notification Letter about Infusion Sets and an Urgent Medical Device Recall Notice about Reservoirs, equipment used to operate the Paradigm insulin pump that are critically important. The Infusion Sets and Reservoirs are medical equipment necessary to keep diabetics alive, by administering appropriate amounts of insulin, but instead may be putting them in danger. The Urgent Medical Device Safety Letter warns that if insulin or other liquids come in contact with the inside of the connector to the Infusion Set, where the Reservoir is connected to the Infusion Set tubing, it can temporarily block vent membranes, causing too little or too much insulin to be delivered. If this happens, either Hyperglycemia (too high a blood sugar level) or Hypoglycemia (too low a blood sugar level) results, which can produce loss of consciousness, coma or even death. One way to recognize if the Infusion Set membranes have been blocked is if during the priming process, insulin continues to drip from the infusion set needle/cannula when priming is completed. The Safety Notification Letter provides instructions on how to minimize liquid from getting in the connector. To minimize insulin from wetting the connector, it is suggested that the insulin vial be held in your hand, below the Reservoir and blue transfer guard, when the Reservoir has been filled and is being removed. The Paradigm Infusion Sets that are affected by this are Models MMT-317, MMT-318, MMT-324, MMT-325, MMT-312S, MMT-312L, MMT-386, MMT-387, MMT-394, MMT-396, MMT-397, MMT-398, MMT-399, MMT-377, MMT-378, MMT-381, MMT-382, MMT-383, MMT-384, MMT-368, MMT-862, MMT-864, MMT-866, MMT-874, MMT-876, MMT-884, Continue reading >>
Paradigm Quick-set 6mm/80cm - Teflon Katheter Mmt-387 / 10 Stck
Paradigm Quick-set 6mm/80cm - Teflon Katheter MMT-387 / 10 Stck Paradigm Quick-set 6mm/80cm - Teflon Katheter MMT-387 / 10 Stck PZN 00365032, Diashop.de Kat.-Nr. 62865 Sie bestellen ohne Rezept - wir liefern Ihnen das Produkt zum dargestellten Preis. verrechnen wir direkt mit Ihrer Krankenkasse, mit dem von Ihnen nachgereichten Rezept Sie bestellen mit Privatrezept - wir liefern Ihnen das Produkt zum dargestellten Preis, Sie verrechnen selbstttig mit Ihrer Krankenkasse. Lieferfrist 1-3 Tage Versand am gleichen Tag bei Bestellungen bis 16:00 Uhr (Montag bis Freitag), ausgenommen an Feiertagen. Inkl. 19% MwSt., zzgl. Versandkosten 10 Insulinpumpenkatheter PARADIGM Quick-set mit Teflonkanle fr alle Insulinpumpen mit Paradigm-Anschluss Mit dem Paradigm-Anschluss kann PARADIGM Quick-set ausschlielich mit den Insulinpumpen MiniMed Paradigm 5er / 7er und Paradigm Veo Serie verwendet werden. - Nadelschutz zur sicheren Entsorgung der Kanle - Direkt an der Insertionsstelle abkoppelbar Die Insulinpumpe ist Ihr stndiger Begleiter. Daher sollte der tgliche Umgang mit ihr durch die Wahl eines passenden Insulinkatheters erleichtert werden. Wichtig ist, dass Sie den Katheter tragen, der Ihren persnlichen Erfordernissen entspricht. Medtronic MiniMed bietet Ihnen ein breites, auf Ihre individuellen Bedrfnisse abgestimmtes Angebot an Insulinkathetern. Der Paradigm Quick-set ist das populrstes Infusionsset, das leichte Handhabung und maximalen Komfort vereint. Die Softkanle wird gerade in einem 90-Winkel zur Hautoberflche insertiert. Die Pflasterrondelle ist bereits integriert. Der Schlauch kann an der Insertionsstelle direkt abgekoppelt werden. Die Quick-set Einfhrnadel ist durch den einzigartigen Klick und weg-Mechanismus nach der Insertion sicher und schnell zu entsorgen. Mit diesen Ei Continue reading >>
Minimed Quick-set Infusionsset
Wir prfen gerade Ihre Profilangaben. Whrend dieser Bearbeitungszeit knnen Sie leider noch keine Einkufe im eShop machen. Dieses Produkt ist verschreibungspflichtig. MiniMed Quick-set: Tragekomfort und leichte HandhabungDas MiniMed Quick-set Infusionsset berzeugt durch maximalenTragekomfort und leichte Handhabung. Durch die Einfhrung der Teflonkanle senkrecht in die Haut, eignet sich Quick-set ideal fr Kinder und Erwachsene mit normalem und strkerem Krperbau. MiniMed Quick-set: Tragekomfort und leichte HandhabungDas MiniMed Quick-set Infusionsset berzeugt durch maximalenTragekomfort und leichte Handhabung. Durch die Einfhrung der Teflonkanle senkrecht in die Haut, eignet sich Quick-set ideal fr Kinder und Erwachsene mit normalem und strkerem Krperbau. Gebrauchsinformation: Das Quick-set Infusionsset bietet Ihnen die Vorteile einer Abkopplung direkt an der Einfhrstelle und ein integriertes Pflaster fr ein diskretes und flaches Erscheinungsbild. Softkanle erhltlich in den Lngen 6mm und 9mm. Sicheres "Klick und Weg" System zur Nadelentsorgung. Alle MiniMed Schluche und Reservoire sind mit dem einzigartigen MiniMed-Anschluss ausgestattet, der eine sicherere Insulinabgabe gewhrleistet. Fr eine gute Insulinabsorption und zur Vermeidung von Verschlssen, sollten Sie Ihre Infusionsset regelmig wechseln. Es wird empfohlen, Ihr Quick-set Infusionsset alle 48 bis 72 Stunden zu wechseln. Continue reading >>
Medtronic Minimed Paradigm Recall Issued For Insulin Infusion Sets
Medtronic MiniMed Paradigm Recall Issued for Insulin Infusion Sets A class I recall has been issued for insulin infusion sets, after a problem was detected that may cause Medtronic MiniMed Paradigm pumps to administer too much or too little insulin, which could cause serious or even fatal health consequences for diabetics. The Medtronic MiniMed Paradigm Insulin Infusion Set recall was announced by the U.S. Food and Drug Administration on June 7, due to an issue where fluids may come in contact with the tubing connector of the MiniMed Paradigm pumps. If the vents become blocked, the pump may not prime itself properly, causing the device not to work properly. Due to the serious risk posed for diabetics who rely in the infusion pump to maintain acceptable blood glucose levels, the FDA has categorized an urgent medical device safety notification issed by Medtronic on June 7 as a Class I recall, suggesting that continued use of the infusion sets poses a reasonable risk of serious adverse health consequences or death. The recall affects Medtronic MiniMed Paradigm Insulin Infusion Sets manufactured from October 2001 through June 2013, which were distributed from December 2001 through June 2013, including the following Medtronic models; MMT-317, MMT-318, MMT-324, MMT-325, MMT-312S, MMT-312L, MMT-386, MMT-387, MMT-394, MMT-396, MMT-397, MMT-398, MMT-399, MMT-377, MMT-378, MMT-381, MMT-382, MMT-383, MMT-384, MMT-368, MMT-862, MMT-864, MMT-866, MMT-874, MMT-876, MMT-884, MMT-886, MMT-921, MMT-923, MMT-925, MMT-941, MMT-943, MMT-945, MMT-961, MMT-963, MMT-965, & MMT-975 Paradigm Infusion sets. In 2009, Medtronic Inc. issued a similar recall for approximately three million Quick-set infusion sets used with its MiniMed Paradigm insulin pumps, due to a manufacturing defect that could Continue reading >>
Field Safety Notice - 11 To 15 September 2017
Field Safety Notice - 11 to 15 September 2017 Summary List of field safety notices (FSNs) from medical device manufacturers from 11 to 15 September 2017. If you receive a field safety notice (FSN) from a manufacturer you must always act on it. MHRA publishes the following for information only. If you have a question about a particular FSN contact the manufacturer. Biomet: Ziptight Ankle Syndesmosis Fixation CRISTALENS INDUSTRIE: ARTIS, EAZ, LUXIOL, NAVIGO Medtronic MiniMed Quick-set (MMT-394, 384, 399, 387, 398, 397,386, 396) Medtronic MiniMed Silhouette (MMT-377, 378, 384, 368, 381, 382,383) Medtronic MiniMed Sure-T (MMT-862, 862T, 864, 866, 874, 876, 884,886) Medtronic MiniMed Mio (MMT-921, 923, 925, 941, 943, 945, 961, 963,965, 975) Depuy Synthes: DELTA XTEND Reverse Shoulder System Philips: X-ray system, diagnostic, computed tomography, full-body Randox Laboratories: Liquid Cardiac Control - Level 3 Siemens: ACUSON S Family with SW vers. VD10A or VD10C Thermofisher Scientific: Thermo Scientific Oxoid Antimicrobial Susceptibility Test disc CAZ10 Ceftazidime Dont include personal or financial information like your National Insurance number or credit card details. To help us improve GOV.UK, wed like to know more about your visit today. Well send you a link to a feedback form. It will take only 2 minutes to fill in. Dont worry we wont send you spam or share your email address with anyone. Continue reading >>
Solara Medical Supplies
Flexible Spending Account (FSA) Eligible Products? This product is FSA Approved which means that is typically eligible for purchase using a Flexible Spending Account. FSA coverage can vary from plan to plan, and your individual employer ultimately determines which products and services are eligible for coverage. Please refer to your employer or plan for the exact details of your flexible spending account before using it. The Quick-set provides the convenience of a disconnect at the infusion site and a pre-attached adhesive for a discreet, low profile design. The Quick-set offers the option of a 6mm soft cannula for leaner bodies or a 9mm soft cannula for most everyone else that is inserted at a 90-degree angle. The Safe Needle Disposal System of the Quick-set helps prevent "accidental stickings" when disposing of the introducer needle in a sharps container. The Quick-set works with the Quick-serter to provide optimal insertion every time! Paradigm Infusion Sets are only compatible with the Paradigm Pump. Rx Required: In the US, this product requires a prescription from your doctor before purchase. This item is restricted by federal law to sale by or on the order of a physician. The price listed is the retail price. For orders billed to your insurance, the actual price is based on the contracted rate. Continue reading >>
Minimed Quick-set Infusion Sets
MiniMed Quick-set : Comfort and ease MiniMed Quick-set is a popular MiniMed infusion set, combining great comfort and ease of use. Its soft cannula, hypoallergenic tape and ease of insertion with the Quick-Serter device, even in hard-to-reach areas, makes it a great choice for children and adults of average to large build. It is recommended to order infusion sets direct from the NDSS , if you are eligible. Soft cannula of 6mm or 9mm, available in various tubing lengths. Quick-serter insertion device for one-handed 90 insertion. The Quick-set infusion set provides the convenience of a disconnect at the infusion site and a pre-attached adhesive for a discreet, low profile design. Available in either 6mm or 9 mm soft cannula. Works with Quick-serter to provide optimal insertion. All MiniMed infusion sets tubing and reservoirs are designed with a unique MiniMed connection for a more secure insulin delivery. For a better insulin absorption, and to help avoid insulin degradation and infusion set occlusion, you should change your infusion regularly. It is recommended to change your Quick-set infusion set every 48 to 72 hours. MiniMed Quick-set Infusion Set 9mm Cannula, 80cm Tubing (10/box) MiniMed Quick-set Infusion Set 6mm Cannula, 80cm Tubing (10/box) MiniMed Quick-set Infusion Set 9mm Cannula, 110cm Tubing (10/box) MiniMed Quick-set Infusion Set 9mm Cannula, 60cm Tubing (10/box) MiniMed Quick-set Infusion Set 6mm Cannula, 110cm Tubing (10/box) MiniMed Quick-set Infusion Set 6mm Cannula, 60cm Tubing (10/box) Continue reading >>
Minimed Quick-set Infusionsset
MiniMed Quick-set: Confort et simplicitMiniMed Quick-set est un cathter MiniMed trs demand qui associe un grand confort et une simplicit d'utilisation. Sa canule souple, son adhsif hypoallergnique et sa facilit d'insertion grce au dispositif Quick-serter, mme dans des zones difficiles d'accs, en font un choix idal pour les enfants et les adultes de corpulence moyenne forte. Canule souple de 6mm ou 9mm, disponible avec diffrentes longueurs de tubulures. Dispositif d'insertion Quick-serter disponible pour une insertion 90 une main. Informations d'utilisation: Le cathter Quick-set permet une dconnexion aise au site de perfusion et comporte un adhsif prfix pour une conception simple et discrte. Disponible avec une canule souple de 6mm ou 9mm. Systme scuris d'limination de l'aiguille. Fonctionne avec Quick-serter pour permettre une insertion optimale. Compatible avec la pompe insuline Paradigm. Tous les cathters et rservoirs MiniMed sont conus avec une connexion MiniMed unique pour une administration d'insuline plus fiable. Pour une meilleure absorption de l'insuline, et afin d'viter la dgradation de l'insuline et l'occlusion du cathter, il est ncessaire de changer votre cathter rgulirement. Il est recommand de changer votre Quick-set toutes les 48 72 heures. Continue reading >>
Medtronic Paradigm Insulin Infusion Sets
Australian Government Department of Health Recall for product correction - Updating instructions for use Consumers and health professionals are advised that Medtronic, in consultation with the TGA, has initiated a recall for product correction for its Medtronic Paradigm insulin infusion sets. Insulin infusion sets are a tubing system used to deliver insulin from an insulin pump to the patient's body. Medtronic Paradigm insulin infusion sets are used with Medtronic Paradigm insulin pumps for the control of insulin-dependent diabetes. A potential safety issue has been identified if insulin or other fluids come in contact with the inside of the Medtronic Paradigm insulin infusion set's connector, which connects the tubing system to the insulin reservoir. This is most likely to occur after the insulin reservoir is filled. If this occurs, fluid can temporarily block the vents in the connector that allow the pump to prime before use. This can result in too much or too little insulin being delivered to the patient, which can cause hypoglycaemia or hyperglycaemia and require immediate medical attention. Medtronic has written to health professionals and Medtronic Paradigm insulin pump users, providing further information about this issue, including advice on how to prevent it from occurring. The Instructions for Use for this device are being updated to address this issue. Please note that Medtronic Paradigm insulin infusion sets are not being recalled from the market. Please check the model number of any Medtronic Paradigm insulin infusion sets to see if they are affected by this issue. If you have any affected devices, you can continue to use them after noting the below information, which will advise you on how to prevent this issue from occurring. Follow the below recommended Continue reading >>
Cr3 Diabetes Association Donation Form
301 Kilmayne Dr., Suite 103 Cary, NC 27511 To donate equipment or supplies, please fill out this form and click SUBMIT at the bottom. PLEASE NOTE WE ARE ONLY ACCEPTING DONATIONS OF THE PUMPS AND SUPPLIES THAT ARE LISTED ON THIS FORM. Items marked with a red asterik(*) are required fields. PUMP DONATION SECTION : You May Donate up to 3 Insulin Pumps on this form. Please fill out one section per pump being donated. PLEASE NOTE WE ARE ONLY ACCEPTING DONATIONS OF THE PUMPS AND SUPPLIES THAT ARE LISTED ON THIS FORM. If you are donating less than 3 pumps, please skip questions that do not need to be answered. RESERVOIR DONATION SECTION : Please list # of FULL Boxes being donated. FULL BOXES CONTAIN 10 RESERVOIRS EACH PLEASE NOTE WE ARE ONLY ACCEPTING DONATIONS OF THE PUMPS AND SUPPLIES THAT ARE LISTED ON THIS FORM. # of FULL BOXES OF 1.8ml - MMT -326a RESERVOIRS # of FULL BOXES OF 3.0ml - MMT -332a RESERVOIRS INFUSION SETS DONATION SECTION : You May Donate up to 2 different types of Infusion Sets on this form. Please fill out one section per type of Infusion Set being donated. Please list # of FULL Boxes being donated. FULL BOXES CONTAIN 10 SETS EACH Maximum Allowed: 250 characters. Currently Used: 0 characters. Continue reading >>
Class 1 Device Recall Medtronic Minimed Paradigm Insulin Infusion Sets
Class 1 Device Recall Medtronic MiniMed Paradigm Insulin Infusion Sets Class 1 Device Recall Medtronic MiniMed Paradigm Insulin Infusion Sets Medtronic MiniMed Paradigm Insulin Infusion Sets The Paradigm infusion sets are intended for use with Paradigm insulin infusion pumps. This field correction involves models: MMT-317, MMT-318, MMT-324, MMT-325, MMT-312S, MMT-312L, MMT-386, MMT-387, MMT-394, MMT-396, MMT-397, MMT-398, MMT-399, MMT-377, MMT-378, MMT-381, MMT-382, MMT-383, MMT-384, MMT-368, MMT-862, MMT-864, MMT-866, MMT-874, MMT-876, MMT-884, MMT-886, MMT-921, MMT-923, MMT-925, MMT-941, MMT-943, MMT-945, MMT-961, MMT-963, MMT-965, & MMT-975 Paradigm Infusion sets. Medtronic is recalling the Medtronic MiniMed Paradigm Medtronic is recalling the Medtronic MiniMed Paradigm Insulin Infusion sets because of a potential safety issue that can occur if insulin or other fluids come in contact with the inside of Medtronic Paradigm infusion sets. Under certain conditions, the infusion set may malfunction and deliver an incorrect volume of insulin. Medtronic, Inc. sent an Urgent Medical Device Safety Notification letter dated June 10, 2013, to all affected consignees. The letter identified the product and notified healthcare professionals of the potential for over or under delivery of insulin if insulin or other fluids contact the inside of Medtronic Paradigm Tubing Connectors. The letter informed the consignees that it applies to all Medtronic infusion sets designed for use with Medtronic Paradigm family infusion pumps. Paradigm Insulin Pump users, distributors, and healthcare professionals were all instructed to contact Medtronic's 24 hour helpline at (888) 204-7616.For questions regarding this recall call 818-567-4700. Worldwide distribution: US (nationwide) distribution: Al Continue reading >>
