Class 1 Recall: Hospira Inc., GemStar Infusion System, Lithium Battery - Low Voltage
The GemStar Infusion System is a small, lightweight, single-channeled device designed for use in the home, hospital or anywhere electronic infusion is required.
Mon Mar 18 2013
Battery failure resulting in delay/interruption of therapy and loss of data.
When the GemStar Lithium battery voltage level drops below 2.4 volts, an "11/004" error is displayed and the device is rendered inoperable. This failure mode results in a delay/interruption of therapy. Additionally, infusion settings and event history logs will be erased as a result of this device malfunction.
The severity of the clinical impact, due to the delay/interruption in therapy, is dependent upon the underlying condition of the patient and the treatment being prescribed. A delay/interruption in therapy has a worst case potential to result in a significant injury or death.
Health care 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 product, particularly in patients in which a delay/interruption in therapy could result in significant injury or death.