All GemStar Family of Infusers: GemStar Infusion System - Single Therapy, GemStar 7 Therapy Infusion System 의 리콜

Recall

RC-2013-RN-00245-1

Class II

2013-04-11

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00245-1

Leakage from the aa battery causes a barrier to the power contacts resulting in no power being delivered, and in some instances the leakage results in contamination or corrosion of the power circuitry. excessive voltage ingress (voltage from the outside ac power adapter) to voltage regulators can cause them to fail. failure of these regulators may result in the device shutting off without issuing a warning or an audible or visual alarm. if the device shuts off it will result in a delay/interruption in therapy.

As directed by the Gemstar Technical Service Manual (TSM), the internal AA batteries and battery compartment should be inspected for signs of leakage, corrosion or other damage prior to each use. In addition, each time the batteries are replaced the battery compartment should be inspected for damage. If a device exhibits damage caused by leaking batteries, immediately remove it from clinical service and return it to Hospira for repair. 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.