Medical device manufacturer Medtronic recently recalled two of its drug infusion pumps after receiving numerous device failure complaints. Medtronic says that it has received at least 560 complaints regarding motors stalling on its SynchroMed II and SynchroMed EL pumps. The device failure rate is 2.4 percent when the pumps are used with approved drugs and can climb to 7 percent when unapproved medicines are used.
“The SynchroMed pump continues to demonstrate reliability at or above expected levels,” a Medtronic spokesperson told Bloomberg News. “We remain confident in its ability to deliver safe and effective therapy to those who need it.”
The primary contributor to the device failure appears to be corrosion to the motor gears, which increases with time. The U.S. Food and Drug Administration says the problem was first identified five years ago and that no deaths have been linked to device failures.
Medtronic’s urgent letter to health care providers is classified as a Class 1 recall, but the product will remain on the market. The FDA is simply urging health care providers to carefully monitor patients and to use the pumps only with approved medications.
“The use of unapproved drugs can lead to intermittent or permanent pump motor stall and cessation of drug infusion,” the FDA recall notice warns. “A cessation of drug infusion may cause serious adverse health consequences, including death. The firm reminded health care professionals that the SynchroMed pump can experience motor stalls when used with either approved or unapproved drugs. However, pump motor stalls have been reported at a significantly lower rate when approved drugs are exclusively used.”
The FDA recall and Medtronic warning letter cover the following devices and model numbers:
- SynchroMed II, models 8637-40 and 8637-20
- SynchroMed EL, models 8626-10, 8626L-10, 8626-18, 8626L-18, 8627-10, 8627L-10, 8627-18, 8627L-18
Medtronic has reminded health care professionals that the only drugs approved for use in the SynchroMed infusion systems are InfumorphTM, Lioresal®, Prialt® (Ziconotide), loxuridine, Methotrexate and Gablofen®.
Source: Bloomberg, “Medtronic Recalls Drug Pumps After Infusion Failures,” Michelle Fay Cortez, Dec. 21, 2012