UPDATED 05/09/2014. Recall classified by FDA as Class I.
AUDIENCE: Risk Manager, Biomedical Engineer, Nursing
ISSUE: Hospira, Inc., announced today a nationwide medical device correction of the GemStar Docking Station (list number 13075), used in conjunction with the GemStar infusion pump. When the docking station is used in conjunction with a GemStar Phase 3 pump (List 13000, 13100 or 13150) the potential exists for the GemStar Phase 3 pump to fail to power up while connected to the docking station. When a GemStar Phase 3 (List 13000, 13100 or 13150) or GemStar Phase 4 pump (List 13086, 13087 or 13088) is used in conjunction with both a docking station and an external battery pack accessory (List 13073), there is a possibility that the GemStar pump will display error code 11/003 and give an audible alarm, indicating excessive input voltage from the external sources. If the GemStar pump detects what is perceived to be more than 3.6 Volts as measured on the external voltage input, the pump will stop the infusion. This will trigger an audible alarm and the device will display alarm code 11/003.
If a GemStar fails to power up or the 11/003 error code stops an infusion, a delay of therapy may occur. A delay or interruption in therapy has a worst case potential to result in significant injury or death.
BACKGROUND: The GemStar Docking Station is a separately sold accessory to the GemStar infusion pump and provides an alternate power source to the GemStar pump. The products impacted by these issues are identified in a table in the Firm Press Release.
RECOMMENDATION: Healthcare professionals are advised to weigh the risk/benefit to patients associated with the use of the device when administering critical therapies. Customers should consider the use of an alternative pump, particularly in patients in which a delay/interruption in/of therapy could result in serious injury or death. There is no need to return the GemStar Docking Station at this time and Hospira recommends that users take the following actions:
1.To avoid a failure to power up, turn the pump on first, before connecting the pump with the docking station. This will prevent the failure to power up.
2.To mitigate the potential for an 11/003 error code, remove the external battery pack accessory (List 13073) from the docking station and pump prior to installing the pump into the Docking Station. If you use a docking station in conjunction with an external battery pack accessory (List 13073), this practice sould not continue. Please contact Hospira to discuss an appropriate alternative option.
Users who experience a failure to power up or an 11/003 error code should report the issue to Hospira by calling 1-800-441-4100 (M-F, 8am-5pm CT) or email ProductComplaintsPP@hospira.com. For additional assistance or to obtain a copy of the Urgent Medical Device Correction letter and/or a reply form, please contact Stericycle at 1-866-792-5451 (M-F, 8am-5pm ET).
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178