Medical device manufacturer, Hospira, has issued a medical device safety alert concerning Q core's Sapphire Infusion Pumps (Hospira List number: 163113601).
The manufacturer's investigation and analysis has determined that with specific drug concentrations of iron sucrose (range of 0.7 to 2.8mg/mL, "Concentration Range") the pump may misinterpret the iron sucrose solution as air rather than an opaque solution, resulting in the generation of a false air-in-line alarm.
Risk to health is limited to a delay in the administration of iron sucrose infusion in the Concentration Range only. The issue, if occurs, is immediately apparent to the provider at the beginning of the treatment as an Air-In-Line alarm is generated, which does not allow the treatment to start. In addition, iron sucrose therapy is not used for acute treatment of anaemia, the effected of iron sucrose takes days to occur, and alternative delivery mechanism are readily available. Thus the risks of delay in therapy of intravenous iron sucrose are remote.
According to the manufacturer, intensive research has not revealed any other medication which raises the same issue, i.e., this issue is unique for iron sucrose and no other drug. The software algorithms within the pump are being improved to restore the device to its original specifications, enabling consistent delivery of the aforementioned concentration of iron sucrose. This improvement will address the root cause and prevent the false alarms.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 24 May 2016