A class 1 recall has been issued for 2 Medtronic infusion pumps after the company reported that using unapproved drugs can lead to intermittent or permanent pump motor stall, the US Food and Drug Administration (FDA) said today.
To minimize the potential for motor stall, the firm recommends that health professionals use only the approved drugs that are indentified in the SynchroMed II and SynchroMed EL implantable drug infusion pumps' labeling. Compounded drugs, unapproved concentrations, or unapproved formulations should not be used, the FDA said in an alert.
Motor stall can lead to cessation of drug infusion that may cause serious health consequences, including death. A class 1 recall is the most serious type of recall. However, the company is not retrieving the product from the field or recommending removal of the product.
At this time, the approved drugs for use with the SynchroMed infusion pump are infumorp, lioresal, Prialt (ziconotide; Jazz Pharmaceuticals), floxuridine, methotrexate, and gablofen, the FDA said. These pumps were manufactured from May 1998 through November 2012 and distributed from April 1999 through November 2012.
Model numbers in the recall are SynchroMed II models 8637-40 and 8637-20 (the pump is supplied in 20- and 40-mL reservoir sizes) and SynchroMed EL models 8626-10, 8626L-10, 8626-18, 8626L-18, 8627-10, 8627L-10, 8627-18, and 8627L-18.
The overall failure rate of the SynchroMed II pump at 78 months postimplant is 2.4% when used to dispense approved drugs and 7.0% when used to dispense unapproved drugs, according to data from the firm's implantable systems performance registry. The firm reminded healthcare professionals that the 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 issued 2 class 1 recalls for the SynchroMed infusion pump in 2011 for potential problems with battery performance and "pocket fills," in which the drug is injected into the pump pocket (the area under the skin where the pump is placed) instead of the pump. Between 1996 and 2010, 8 deaths and 270 events requiring medical intervention were reported related to the occurrence of pocket fills, according to the FDA.
More information is contained on the FDA's Web site.
To report problems with the pumps, contact MedWatch, the FDA's safety information and adverse event reporting program, by telephone at 1-800-FDA-1088; by fax at 1-800-FDA-0178; online at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm; with postage-paid FDA form 3500, available at https://www.fda.gov/MedWatch/getforms.htm; or by mail to MedWatch, 5600 Fishers Lane, Rockville, Maryland 20852-9787.
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Cite this: FDA Issues Recall of Infusion Pumps Due to Motor Stall - Medscape - Dec 24, 2012.