FDA, Medtronic issue advisory on SynchroMed drug infusion pump failures

The Food and Drug Administration has issued a warning that some Medtronic SynchroMed drug infusion pumps may malfunction and this could result in serious injuries or death.

According to a Minnesota Public Radio report, the announcement from the agency is being conducted in conjunction with the manufacturer but a recall is not being conducted. The SynchroMed drug infusion pumps will remain on the market.

The announcement this week stresses previous announcements from both the agency and Medtronic. These devices are more likely to fail when they are used to deliver unapproved drugs. The report does not indicate exactly what drugs should be delivered through the SynchroMed pumps. When a drug that’s not been approved for delivery via a SynchroMed pump, the possibility of errors are greater, the company said.  

In a statement from Medtronic, a company spokesperson said, “This is not a new issue. Our pump continues to demonstrate reliability at or above expected levels and we remain confident in the ability to deliver safe and effective therapy to those who need it.”

Data from the FDA shows that when unapproved prescription drugs are delivered through a SynchroMed infusion pump they are three times more likely to cause a malfunction. In this case, a malfunction occurs when the infusion pump motor stalls. This results in a drug not being delivered. Depending upon which prescription drug is being administered and for which purposes, the lack of the drug could result in serious injuries, severe pain, or even death.

The FDA and Medtronic are advising patients and health care professionals to provide constant monitoring of a patient using a SynchroMed pump to deliver their drugs. Infusion pumps are often used in patients who require constant or round-the-clock medical care or who must receive a certain drug on a consistent basis or over a longer period of time.

The risk of a SynchroMed motor stalling is still present even if an approved drug is used. Patients should always be monitored if they’re using a SynchroMed or any type of drug infusion pump.


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