According to MedPage Today, December 26, the U.S. Food and Drug Administration (FDA) issued a Class I recall—which indicates there could be a reasonable risk of serious adverse event or death with use of two infusion pumps whose motors can fail when used with drugs not previously approved for use with these particular pumps. The infusion pumps which have been recalled are the SynchroMed II Implantable and the SynchroMed EL Implantable infusion pumps. These pumps may stall intermittently or permanently halt, preventing delivery of medications which could cause adverse reactions and death of patients.
Model numbers of the pumps affected by this Class I recall are:
SynchroMed II Models 8637-40 and 8637-20
SynchroMed EL Models 8626-10 and 8627L-10
Models 8626-18 and 8626L-18
Models 8627-10 and 8627L-10
Models 8627-18 and 8627L-18
The only drugs reportedly approved for use with these particular infusion pumps are: morphine (Infumorph), baclofen (Lioresal and Gablofen), ziconotide (Prialt), floxuridine, and methotrexate.
Healthcare professionals have been notified by mail that the failure rate of these pumps increased from 2.4% to 7% when used with drugs that had not been approved for use in these pumps. Medtronic warned healthcare professionals in a letter “to avoid using compounded drugs, unapproved concentrations and unapproved formulations with these pumps.”
Medtronic also communicated to health professionals that should a motor stall occur, patients should be monitored for a return of baseline symptoms, which might indicate damage to the device (following the stall). In addition if the infusion pump motors ceased working properly, signs of [drug] withdrawal might occur in patients and caregivers and patients needed to be alerted to this possibility.
The company, Medtronic, is investigating corrosion problems with the pump’s motor gear “which has been identified as a primary contributor to permanent motor stall.” (MedPage Today, 12/26/12)