Medical device manufacturer, Medtronic, has issued a field safety notice concerning SynchroMed II Implantable Drug Infusion Pump.
The manufacturer detected an upward shift in reports of occurrence for overinfusion, which is defined as an infusion rate exceeding the programmed infusion rate by more than 14.5% as described in the labeling. When overinfusion occurs, it will result in a volume discrepancy at pump refill, where the volume withdrawn from the pump is less than the volume expected.
The cause for pump malfunction leading to overinfusion remains under investigation and has not been linked to any specific pump lot, drug used, or geographical area.
The manufacturer is not recommending prophylactic replacement of pumps. Users are advised to always follow pump refill instructions per the device labeling to allow detection of an overinfusing pump.
The manufacturer advises users to inform them if overinfusion is strongly suspected and return any explanted products to the manufacturer for mechanical and functional analysis.
According to the local supplier, the affected products were distributed in Hong Kong.
If you are in possession of the affected product, please contact your supplier for necessary actions.
Posted on 18 March 2014