Medtronic Issues Synchromed Infusion Pump RecallJuly 01, 2013
July 1, 2013
Medical device manufacturer Medtronic initiated recall of its Synchromed infusion pump systems due to three major flaws that may lead to serious health consequences. Following the initiative, the US Food and Drug Administration (FDA) alerted health professionals and patients with the recent medical device recall.
The FDA classified the recalls as Class I from the three notifications issued by Medtronic, with the fourth related to a recall in 2011. Each flaw, according to FDA, poses threat to serious health risk to patients, including death.
The recent recall involved three infusion systems and products, namely SynchroMed II andSynchromed EL implantable infusion pump, andSutureless Connector Intrathecal Catheter. The implantable infusion pumps may harm patients for unintended drug delivery during priming bolus procedure. The systems are also prone to internal electric short circuit that may result to loss or failure of medical therapy to the patient. The medical company also announced recall of previous design of itsSutureless Connector Intrathecal Catheter that may cause occlusion. Occlusion happens when the catheter is misaligned to an implantable infusion pump, causing blockage or stoppage of drug flow.
Medtronic also said that the company has started rolling outan updated Clinician Refill Reference Card on the pump refill procedure for the SynchroMed Implantable infusion system..The revised reference card provides new product labeling, guiding healthcare professionals to avoid occurrences of pocket fill when performing a SynchroMed pump refill procedure. Pocket fill happens when the patient’s subcutaneous tissues are injected with the prescribed drug during refill procedure, instead of into the pump.
FDA encourages clinicians and patients to report any adverse incidents or side effects related to the use of the affected products. Reports regarding any harmful events caused by the Medtronic products due for recall can be addressed to the agency’s Medwatch Safety Information and Adverse Event Reporting Program.Clinical supervision and properly-maintained infusion pump systems contribute to error-free infusion drug delivery and high-quality patient care. AIV offers parts and services for most leading infusion pumps in the market. Browse through AIV’s replacement parts and repair services at http://www.aiv-inc.com/iv-infusion-pump-replacement-parts.html.
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