FDA Issues Class 1 Recall for Medtronic Infusion PumpsJanuary 03, 2013
January 3, 2013
The United States Food and Drug Administration (FDA) recently issued a Class 1 recall for two Medtronic Infusion pumps- the SynchroMed II Implantable and the SynchroMed EL Implantable. A Class 1 recall indicates that there is a reasonable risk of serious adverse event or death with the use of the equipment.
The recalled infusion pumps were found to stall intermittently or permanently which could prevent proper delivery of medication.
Model numbers affected by the recall are SynchroMed II models 8637-40 and 8637-20 and SynchroMed EL models 8626-10, 8626L-10, 8626-18, 8626L-18, 8627-10, 8627L-10, 8627-18, and 8627L-18. These infusion pumps were manufactured from May 1998 through November 2012 and distributed from April 1999 through November 2012.
"Based on data from the firm's Implantable Systems Performance Registry, the overall failure rate of the SynchroMed II pump at 78 months post implant is 2.4% when used to dispense approved drugs, and 7.0% when used to dispense unapproved drugs," the FDA reported.
Medtronic advised healthcare professionals to avoid using compounded drugs, unapproved concentrations and formulations with these infusion pumps to minimize the occurrence of motor stall.
Improved infusion pump safety will lead to more effective patient care and reduced medication errors. To achieve these goals, it is essential to use infusion pump systems that are properly-serviced and in good working condition. AIV offers parts and services for most leading infusion pumps. Browse through AIV’s replacement parts and repair services at www.aiv-inc.com/iv-infusion-pump-replacement-parts.html.
To know more about recent medical device recalls, visit http://www.fda.gov/safety/recalls/default.htm.
About the Author
AIV CatalogRequest Your Printed or Electronic Copy Today!
Be Part of Our
Healthcare technology management professionals are a vital link in hospital operations, and we proudly support the national, state, and local associations with ongoing support and resources.Get Biomed Resources
Why buy from AIV
AIV strives to provide you cost effective options to service equipment. We offer flexible solutions to best suit your needs.