Medtronic Synchromed Infusion Pump Recall: Drug Overdose Risk

A recall has been issued for Medtronic SynchroMed infusion pumps due to design problems, which may lead to refill errors where doctors unknowingly miss the device and inject the drugs directly into the patient. This has resulted in hundreds of reported problems with the Medtronic SynchroMed pump, including at least eight deaths.

The FDA classified the Medtronic SynchroMed Infusion Pump recall as a Class I medical device recall this week, meaning that the infusion pump problems carry a reasonable probably of causing serious injury or death.

Last month, Medtronic, Inc. sent an “Urgent: Medical Device Correction” letter (pdf) to health care providers warning them that there was a chance that doctors trying to refill pumps implanted in patients could mistakenly inject the drugs directly into the patient’s subcutaneous tissue without knowing it. Known as a “pocket fill,” this could cause serious injury or death due to drug overdose or could cause the patient not to receive the proper amount of medication.

According to Medtronic’s letter, there have been at least 351 reports of pocket fill problems involving the SynchroMed infusion pump from May 1996 to September 2010. Eight people have died and 270 required medical intervention due to a serious or life threatening injury. Another 58 events are known that did not cause serious injury and there were 15 events where Medtronic did not know the outcome.

Medtronic estimates, based on the reports, that about 1 in every 10,000 SynchroMed drug refill attempts by health care professionals result in a pocket fill. However, the company said the actual rate of occurrence could be much higher, because it is likely that the medical mistakes are under reported.

The recall affects the SynchroMed II Programmable Pump (model no. 8637), the SynchroMed EL Infusion System (model nos. 8626 and 8627) and Medtronic refill kits (model nos. 8551, 8555, 8561, 8562, 8564, 8565, and 8566). Refill kits for the Medtronic MiniMed Infusion Pumps are not affected.

Medtronic’s letter instructs doctors and other healthcare professionals using the affected medical devices to check needle placement within the pump septum during the drug refill. The needle must be inserted until it has reached the needle stop in the pump reservoir. In addition, health care professionals, patients and caregivers should be alert to signs of drug overdose, underdose, and withdrawal after every refill.

Any incidents related to the use of the affected pumps should be reported to the FDA’s MedWatch adverse event reporting program at www.fda.gov/MedWatch.