Two types of Medtronic drug infusion pumps have been recalled after it was found that the devices sometimes fail to deliver medicines. The device maker sent an urgent safety device notification to doctors in early November that the U.S. Food and Drug Administration has deemed to be a recall.
Medtronic recently notified healthcare professionals that using unapproved drugs with the SynchroMed Infusion Pump may negatively impact the pumps performance, the FDA notification stated. Based on data from the firms Implantable Systems Performance Registry, the overall failure rate of the SynchroMed II pump at 78 months post implant is 2.4 percent when used to dispense approved drugs, and 7.0 percent when used to dispense unapproved drugs. The use of unapproved drugs can lead to intermittent or permanent pump motor stall and cessation of drug infusion.
It should be noted that unlike most recalls, these potentially defective medical devices will remain on the market. Device failures have been mostly linked to corrosion in older pumps. The problem was first identified in 2007 and there have been over 550 complaints regarding failing devices. No deaths have been linked to device failure.
The FDAs refusal to pull the devices from the market might signal that the agency views this as a case of device misuse instead of a true product defect. This means that patients who suffer adverse medical outcomes linked to the devices could have an inadequate product warning case against Medtronic and a medical negligence action against their medical provider.
The recall impacts the Medtronic SynchroMed II Implantable Drug Infusion Pump and the SynchroMed EL Implantable Drug Infusion Pump.
Here are the model numbers for the impacted devices:
SynchroMed II, models 8637-40 and 8637-20 (The SynchroMed II Pump is supplied in 20 ml or 40 ml reservoir sizes.)
SynchroMed EL, models 8626-10, 8626L-10, 8626-18, 8626L-18, 8627-10, 8627L-10, 8627-18, 8627L-18
Source: Bloomberg, Medtronic Recalls Drug Pumps After Infusion Failures , Michelle Fay Cortez, Dec. 21, 2012<< BACK TO BLOG POSTS