The United States Food and Drug Administration (FDA) posted a medical device safety alert concerning GemStar Power Supply, 3VDC, manufactured by Hospira.The affected devices are identified as follows:

• Wall Mount Power Supply [List number:13026-05]
• Desk Top Power Supply [List number:13072-05]

According to the FDA, the power supply may not properly deliver electric power to the GemStar Infusion Pump. If the power supply fails, planned infusion therapy may be delayed if a backup power supply is not used. The manufacturer received a total of 20 reported incidents including one report of smoke and found that the GemStar Infusion Pump was operating on battery power while connected to the 3VDC power supply. There were no reports of injuries or death.

The manufacturer advises users to take the following precaution:

• Avoid arcing, wiggling, or dropping the power supply on hard surfaces. Doing so may result in internal damage that would stop the power supply from working.

Affected users are advised to remove the power supply from service. According to the manufacturer, there is no need to return fully functional power supplies (unless they malfunction).

For details, please refer to the following FDA websites:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm421951.htm
http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm421946.htm

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 6 November 2014