Minimax Hardshell Venous Reservoir From Medtronic
The Minimax® Hardshell Venous Reservoir is designed to support a wide range of children requiring gentle and effective blood drainage. This smaller reservoir creates reduced blood contact with a foreign surface. Minimax Hardshell Venous Reservoir offers the following features: Built-in cardiotomy filter provides effective 20-micron filtration Integrated venting system prevents excess pressurization Bottom venous entry allows for easy drainage from patient with minimal foreign surface contact Contoured shell offers optimum low-level visibility and safety Continue reading >>
Microbubble Generation And Transmission Of Medtronic’s Affinity Hardshell Venous Reservoir And Collapsible Venous Reservoir Bag: An In-vitro Comparison
Go to: Microemboli are implicated in neurological injury; therefore, the extracorporeal circuit (ECC) should not generate microbubbles or transmit introduced air. The venous reservoir is the first component in the ECC designed to remove introduced air. The purpose of this study was to investigate the relative safety of two kinds of adult venous reservoirs—the closed soft-shell venous reservoir (SSVR [Medtronic CBMVR 1600]) and the open hard-shell venous reservoir (HSVR [Affinity NT CVR])—in terms of microbubble generation and introduced air transmission. A recirculating in-vitro circuit was used to compare the two reservoirs with the SSVR further assessed in a fully closed or partially open state. Microbubbles were counted using a Hatteland CMD10 Doppler in the outflow of the reservoirs before (microbubble generation) and after infusing 20 mL/min of air into the venous line (microbubble transmission) while altering pump flow rates (3 L/min; 5 L/min) and reservoir prime (200 mL; 700 mL). Negligible bubble generation was noted in the SSVRs at both flow rates and either reservoir volume. However, microbubble generation was significant in the HSVR at the higher flow rate of 5 L/min and lower reservoir volume of 200 mL. When infusing air, a flow of 3 L/min was associated with insignificant to small increases in microbubble transmission for all reservoirs. Conversely, infusing air while flowing at 5 L/min was associated with significantly more microbubble transmission for all reservoirs at both low and high reservoir volumes. The SSVR is as safe as the HSVR in microbubble handling as the generation and transmission of microbubbles by the SSVR is not more than the HSVR over a range of prime volumes and flow rates. As both reservoirs transmitted microbubbles at higher pump Continue reading >>
Medtronic Paradigm Reservoirs
Because the safety of our customers is our top priority, we are voluntarily recalling certain manufacturing lots of part number MMT-326A (1.8 mL) and MMT-332A (3.0 mL) reservoirs used with our Paradigm insulin pumps. We are recalling these reservoirs due to the potential that reservoirs from these lot numbers may be at increased risk for leaking. A leak in the reservoir may result in delivery of less insulin than intended. In addition, if you have a leaky reservoir and an insulin blockage occurs in the infusion set, the pump may not alarm to notify you. Our investigation has indicated that this increased potential for reservoir leakage was caused by abnormal wear on a manufacturing tool involved in the production of reservoir stoppers. We are recalling all lots of reservoirs that contain any stoppers from that tool. We have corrected this problem and have placed additional testing and inspection steps into our manufacturing process. We are instructing all customers not to use reservoirs from these lot numbers and are providing replacement product at no additional charge. We are asking customers to verify the lot numbers of the reservoirs they have on hand using our online tool. If the tool determines that any of your lot numbers are affected, further instructions will be provided within the tool. For any further questions about this issue, please contact us at 1.866.450.0890 Monday through Friday, 8AM – 6 PM Central Time. At Medtronic, making quality products that you can trust is our top priority. We are committed to improving our products and to communicating about potential issues when they arise. We will continue to communicate as often as needed because we know that is what you expect from Medtronic as your partner in diabetes care. We believe doing so makes our Continue reading >>
New Look For Infusion Set And Reservoir Boxes
We are excited to inform you that we are updating the look for our infusion set and reservoir boxes. We hope this will improve your experience by creating a clean, modern and uniform look for our infusion sets and reservoirs boxes. In addition, we have made it easier to identify the days of use reminder for proper infusion set and reservoir wear. Note: there are no changes to the products or packaging material. The new look will be gradually introduced starting in May of 2014. Please feel free to contact your local Medtronic representative if you have any questions regarding this information. Thank you for your partnership! Please visit www.medtronicdiabetes.com for detailed product and safety information. Continue reading >>
Recall Of Various Lots Of Medtronic Minimed Insulin Reservoirs
OTTAWA, ONTARIO, Jul 12, 2013 (Marketwired via COMTEX) -- Medtronic Canada Ltd., in consultation with Health Canada, is recalling select lots (see list below) of Paradigm Medtronic MiniMed Insulin Reservoirs, model # MMT-326A and MMT-332A, manufactured by Medtronic MiniMed. These insulin reservoirs are used with Paradigm insulin infusion pumps. Medtronic is recalling these lots due to the potential risk of a leak in the reservoir that may result in under-delivery of insulin. As well, if there is an obstruction in the infusion set, the pump alarm may not be triggered. The under-delivery of insulin may cause hyperglycemia (high blood sugar), and in extreme cases may cause loss of consciousness or death. Medtronic Canada Ltd is notifying all customers who have purchased products from them of this recall and advising them to check their supplies to see if they have received affected lots. The lot number can be found on the side panel of the reservoir box and on the packaging of each individual reservoir. Patients who have devices from the affected lots or who are concerned about this device should contact Medtronic Canada Ltd.'s 24-hour product support line at 1-800-646-4633. Patients who have health concerns related to their use of this device should speak with their health care professional. ------------------------------------------------------------------------ Model Volume Lot Numbers Affected ------------------------------------------------------------------------ MMT-326A 1.8 ml H8500423 H8500472 H8503728 H8539013 H8510440 H862775 ------------------------------------------------------------------------ MMT-332A 3.0ml H8471745 H8469703 H8473106 H8473271 H8476270 H8492449 H8492449 H8496561 H8517079 ----------------------------------------------------------------------- Continue reading >>
- Detailed Review of the MiniMed 670G from Medtronic
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Medtronic Minimed Insulin Reservoirs (mmt-326a And Mmt-332a Models)
Consumers and health professionals are advised that Medtronic Australasia, in consultation with the TGA, is recalling certain batches of the following models of its Medtronic MiniMed insulin reservoirs: MMT-326A (1.8 mL reservoir) MMT-332A (3 mL reservoir) The affected batch numbers that have been supplied in Australia* are: H8442973 H8463297 H8467888 H8469703 H8473271 H8478398 H8492449 H8494645 H8496561 H8510440 H8512826 H8517079 H8539013 H8627745 * There are 47 affected batch numbers worldwide, but only the above 14 have been supplied in Australia. Medtronic MiniMed insulin reservoirs are a single-use medical device intended to be filled with insulin and used with Medtronic Paradigm insulin pumps for the management of insulin-dependent diabetes. It has been identified that the above batches of the reservoirs have an increased risk of leakage, which could result in less insulin being delivered than intended. An investigation of the manufacturing process has revealed the cause of the issue. The problem has now been corrected and extra testing and inspection steps have been introduced to avoid similar issues in the future. Information for consumers Medtronic Australasia has written to Medtronic Paradigm insulin pump users who have received Medtronic MiniMed insulin reservoirs from an affected batch, providing further information about this issue and advice on how to arrange replacement of any reservoirs they currently have (at no cost). Users should check the batch numbers of any unused Medtronic MiniMed insulin reservoirs to see if they are affected by this recall. The batch number can be found on the side panel of the reservoir box and on the packing of each individual reservoir (see picture below). If you only have reservoirs from affected batches, switch to your back Continue reading >>
Reservoirs
The MiniMed reservoirs have been designed to make the filling a convenient process. Minimed reservoir's unique features: Fast, efficient reservoir filling and ease of handling - no assembly required, the reservoir is ready to use Less risk of injury – unlike luer reservoirs, no extra needle to handle, it is incorporated into the TransferGuard Secure, stable and easy reservoir filling - the TransferGuard fits neatly onto the insulin vial The rounded shape is designed to eliminate air bubbles Less leakage or spillage - once the TransferGuard is removed, a silicone membrane seals the reservoir The MiniMed reservoirs are available in 1.8 and 3 ml size in order to meet your daily insulin needs. Continue reading >>
Recall Of Various Lots Of Medtronic Minimed Insulin Reservoirs
OTTAWA, ONTARIO--(Marketwired - Jul 12, 2013) - Medtronic Canada Ltd., in consultation with Health Canada, is recalling select lots (see list below) of Paradigm Medtronic MiniMed Insulin Reservoirs, model # MMT-326A and MMT-332A, manufactured by Medtronic MiniMed. These insulin reservoirs are used with Paradigm insulin infusion pumps. Medtronic is recalling these lots due to the potential risk of a leak in the reservoir that may result in under-delivery of insulin. As well, if there is an obstruction in the infusion set, the pump alarm may not be triggered. The under-delivery of insulin may cause hyperglycemia (high blood sugar), and in extreme cases may cause loss of consciousness or death. Medtronic Canada Ltd is notifying all customers who have purchased products from them of this recall and advising them to check their supplies to see if they have received affected lots. The lot number can be found on the side panel of the reservoir box and on the packaging of each individual reservoir. Patients who have devices from the affected lots or who are concerned about this device should contact Medtronic Canada Ltd.'s 24-hour product support line at 1-800-646-4633. Patients who have health concerns related to their use of this device should speak with their health care professional. Model Volume Lot Numbers Affected MMT-326A 1.8 ml H8500423 H8500472 H8503728 H8539013 H8510440 H862775 MMT-332A 3.0ml H8471745 H8469703 H8473106 H8473271 H8476270 H8492449 H8492449 H8496561 H8517079 How to report side effects to health products: Complaints involving medical devices can be reported to the Health Products and Food Branch Inspectorate by calling the toll-free hotline at 1-800-267-9675, or by writing to: Également disponible en français Continue reading >>
- Detailed Review of the MiniMed 670G from Medtronic
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Everything You Need To Know About Insulin Pumps
Everyone needs insulin to live. Insulin is a hormone that helps our bodies use and store the food we eat. People with Type 1 Diabetes no longer make insulin and have to give insulin in order to sustain life. People with Type 2 Diabetes don’t use their own insulin well, and over time can have trouble making enough. So, all people with Type 1 diabetes and some people with Type 2 diabetes need insulin. When people give insulin injections, they may take 1-2 injections of a long acting insulin every day and 3+ injections of rapid acting insulin for meals and snacks. The typical person with Type 1 Diabetes could take anywhere from 4-7+ injections a day. Many people currently give insulin through an insulin pen or a syringe. But, there is another option, an insulin pump. An insulin pump delivers rapid acting insulin in two ways. First, the pump is programmed to give you insulin every hour throughout the hour referred to basal insulin. Basal, think “base,” is the insulin your body needs even in the absence of food, it is also referred to as background insulin. This basal rate replaces the long acting injection that you take. Second, is bolus, this is the insulin you take for food or to correct a high blood sugar. If you get basal and bolus confused, think “bowl”, as in you eat out of a bowl, to help you remember bolus is for food. Once you are on a pump, all insulin is delivered through the pump and shots are no longer necessary. Components There are a few things necessary to make a pump work. When a pump is shipped to someone: they will also need to send infusion sets, reservoirs, and possibly batteries, depending on your pump. Let’s talk about each component. Infusion Sets An infusion set is the part that is actually inserted into the body and has tubing that conn Continue reading >>
Reservoirs
The MiniMed reservoirs have been designed to make the filling a convenient process. Minimed reservoir's unique features: Fast, efficient reservoir filling and ease of handling - no assembly required, the reservoir is ready to use Less risk of injury – unlike luer reservoirs, no extra needle to handle, it is incorporated into the TransferGuard Secure, stable and easy reservoir filling - the TransferGuard fits neatly onto the insulin vial The rounded shape is designed to eliminate air bubbles Less leakage or spillage - once the TransferGuard is removed, a silicone membrane seals the reservoir The MiniMed reservoir is available in 3 ml size in order to meet your daily insulin needs. Continue reading >>
Review: Medtronic’s Minimed 630g Insulin Pump
I have used the Minimed 630G Insulin Pump System by Medtronic for the past 30 days. This review is my opinion of the pump, both positive and negative. I have used insulin pumps since I got my first Disetronic H-Tron V-100 in 1994. I got a Minimed 506 pump in 1998 and have been a fan of the Minimed/Medtronic pumps since. Until now. Minimed 630G Insulin Pump System The Minimed 630G Insulin Pump System comes with the pump, the CGM transmitter, and a Contour Next Link 2.4 blood glucose meter. The three devices work well together, once set up right. Medtronic also has an early access program. This lets you buy the Minimed 630G now, and upgrade to the upcoming Minimed 670G in spring of 2017. Receiving the Pump The 630G Pump comes in several boxes. The pump comes in an 8″x10″x2.25″ box that has the pump and several small items like clips, batteries, a manual, and a quick start guide. Another box of the same size has the Contour Next Link 2.4 meter. A second box arrived a few days later with the infusion sets and reservoirs, followed by another box a few days later with the CGM sensors. I got another box a week later with the CGM transmitter. In the past, the local Medtronic trainer would call me to train me on using the pump, with a request not to use it before the training. I normally ignore this request, since I have used Minimed pumps for so long. I do go to these trainings every once in a while, but I was never contact this time. Unusual, considering how new this version of the pump is. Even so, the pump was fairly easy to set up. I also got a pile of 8.5″x11″ manuals. One was a “previous pump users manual” and one was a “pump users manual’. There was a large manual in the box that had everything in it. And another “how to use the CGM” manual. Quite d Continue reading >>
Reservoirs
The MiniMed reservoirs have been designed to make the filling a convenient process. Minimed reservoir's unique features: Fast, efficient reservoir filling and ease of handling - no assembly required, the reservoir is ready to use Less risk of injury – unlike luer reservoirs, no extra needle to handle, it is incorporated into the TransferGuard Secure, stable and easy reservoir filling - the TransferGuard fits neatly onto the insulin vial Less leakage or spillage - once the TransferGuard is removed, a silicone membrane seals the reservoir Continue reading >>
Newsflash: Medtronic Launches New Minimed 630g System
A new Medtronic insulin pump is now available in the United States, introducing a new des ign and color-screen as part of a complete makeover to these diabetes devices that have fundamentally looked the same for 30 years! Say hello to the Minimed 630G, which Medtronic announced on Thursday after receiving the FDA's Pre-Market Approval on Aug. 10. This news caught many by surprise, as the California pump-CGM company hadn't previewed this product in advance as they typically do before launches. Instead, they've focused on their forthcoming 670G hybrid closed loop system, expected to be the first-gen commercial Artficial Pancreas system to hit market in 2017. A number of users are actually upset that they weren't warned of this interim product launch, because they've recently purchased new products or upgrades. Others were holding out for the future closed loop system. So we're all wondering: Just what is this 630G that we've heard nothing about before? Remember, Medtronic got FDA approval in September 2013 for its 530G that automatically stops insulin delivery once a user crosses a certain low glucose level. That was step one in moving toward closed loop technology. Next up is their Predictive Low Glucose Suspend (PLGS) features that can anticipate oncoming hypos in advance and shut off insulin to prevent them from happening. That's built into the Minimed 640G system that hit the market outside the U.S. in early 2015. Medtronic ultimately decided it would not pursue bringing that device to the U.S., opting instead to leapfrog that model and focus on getting the first hybrid closed loop 670G to market in 2017. So now, it seems we're getting this 630G as a sort of stop-gap device in between the two D-tech generations. Here's a quick glance at the Minimed 630G: Fresh Design: Continue reading >>
Alabama Medtronic Insulin Pump Lawyer
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 pump's 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 pump's internal electronics, which can prevent the pump's 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 pump's 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 c Continue reading >>
Insulin Infusion Set Recall: Medtronic Paradigm Infusion Sets
Medtronic Diabetes, Inc. has recalled several lots of its Paradigm Insulin Infusion Pumps and MiniMed Insulin Reservoirs, due to the potential for over or under delivery of insulin into the product user’s bloodstream. The devices are used in the company’s Paradigm Insulin Infusion sets. According to the notice Medtronic issued to its users last month, the vents in its Paradigm Infusion Pumps can become blocked if fluid contacts the inside of the device’s tubing connector – causing insulin delivery malfunctioning. The company warns that the resultant conditions, known as hypoglycemia (low blood sugar) and hyperglycemia (high blood sugar), can cause unconsciousness or death in users. The FDA describes infusion pumps, such as Medtronic’s, as an option for diabetic patients to maintain acceptable blood glucose levels. The devices function by pumping small amounts of insulin into the bloodstream through a tube, which is known as the infusion set. Medtronic’s Paradigm Pumps and MiniMed Reservoirs have been recalled due to potential insulin delivery malfunctioning. Pump Malfunction Caused by Fluid Contacting Product Tubing According to the FDA, the risk of malfunction arises when insulin or other fluids come in contact with the inside of the device’s tubing connector. This can happen when the reservoir is filled from a vial of insulin, and can temporarily block the vents in the connector that allow the pump to properly prime. When these vents are blocked, too much or too little insulin may be released into the bloodstream, potentially causing hyperglycemia and hypoglycemia, which can lead to serious illness or death. The company’s letter includes recommended filling procedures to help avoid these potential adverse effects. Risk of Leak in MiniMed Insulin Reserv Continue reading >>
