Recently, it has been reported that SynchroMed infusion pumps manufactured by Medtronic have been found to have four major flaws that have led to 14 patient deaths, leading to a massive FDA recall on SynchroMed devices. In June, Medtronic notified customers about the flaws which may interfere with the safety and reliability of the SynchroMed infusion pump for the delivery of medications. Each of the four flaws has led to a SynchroMed recall (Class I) by the FDA, meaning that the devices have potential life-threatening issues.
An article in BusinessWeek has reported that fourteen patients have died since 1996 while using the SynchroMed device, where, “The most common complication was the inadvertent injection of a drug into the patient’s subcutaneous tissue, rather than into the pump, which led to 11 deaths. Two patients died from a blockage and another from an electrical short.”
Issues may also stem from the SynchroMed’s priming feature, which allows for quicker drug delivery through the implanted catheter, as it allows for the possibility of either dilution of or over-delivery of medication. Medtronic was reported to have recalled two types of devices in December as well, after reports of life-threatening consequences caused by improperly functioning devices and the use of unapproved drugs in the delivery systems.
The implications of these SynchroMed recalls are quite serious, with a primary complication being the death of patients. It has been shown that not only can the devices fail on a mechanical level, they also can fail due to the improper use of unapproved drugs. If you or a loved one has been used a SynchroMed infusion pump, then you may at risk of experiencing one of these serious complications, whether due to device failure or mistaken administration of drugs not safe for use with the SynchroMed.
Due to an exceedingly-high rate of failure associated with SynchroMed and the range of adverse events associated with the product, a number of SynchroMed lawsuits are currently being filed. For a free, no-obligation case consultation, do not hesitate to contact our team of Synchromed lawyers at (855) 452-5529 or by e-mail at email@example.com.
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