Important Safety Alerts

The Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom (UK) posted a medical device safety alert concerning Gemstar Docking Station (list numbers 13075-XX-07, 13075-XX-09) manufactured by Hospira Inc.

Two problems may occur when the above Gemstar Docking Station is used with Gemstar pumps and external battery pack. First, when the Docking Station is used with a Gemstar Phase 3 infusion pump (list numbers 13000-XX, 13100-XX or 13150-XX) the pump may fail to power up while connected to the Docking Station. Second, when the Docking Station is used with a Gemstar Phase 4 infusion pump (list numbers 13086-XX, 13087-XX or 13088-XX) and an external battery pack (list number 13073-XX) the pump may display error code 11/003 indicating excessive input voltage from the external sources. The 11/003 error code will stop infusion if it occurs while an infusion is in progress.

As a delay of therapy may occur which can result in patient injuries, Hospira advises users to:

• use two fresh internal AA batteries if a failure to power up occurs.
• remove the battery pack prior to installing the pump into the docking station in order to mitigate the potential for an 11/003 error code.
• report to Hospira if their pumps experience a failure to power up or an 11/003 error code.

For details, please visit the following MHRA website:
http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/fieldsafetynotices/index.htm

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

Posted on 5 November 2013