All GEMSTAR Family of Infusers; GemStar Infusion System - Single Therapy; GemStar 7 Therapy Infusion System 의 리콜

Recall

RC-2013-RN-00248-1

Class II

2013-04-12

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00248-1

A lithium battery, that is not user accessible, is used to power the memory that stores the current infusion settings and the event history logs when the pump is turned off. if the battery’s voltage level drops below 2.4 volts, an 11/004 error will be displayed and the device will not be able to be used, resulting in a possible delay/interruption in therapy. additionally, the infusion settings and event history logs will be erased.

If the GemStar device displays an 11/004 error, users are advised to immediately remove it from clinical service and return it to Hospira for battery replacement. Lithium batteries that are older than five (5) years should be replaced. A preventative maintenance program is being developed to ensure the lithium batteries are changed out prior to the end of life. 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 delay/interruption in therapy or under/over infusion could result in significant injury or death.