Class I Recall: Hospira’s GemStar Infusion System Over Lithium Battery Issues

hospira_gemstar_fda_recallBattery leakage damage may lead to device shut-off of Hospira Inc.’s GemStar Infusion System. The shut-off occurs with no warning, the U.S. Food and Drug Administration (FDA) just announced. Models 13000, 13100, 13150, 13086, 13087, and 13088, which were manufactured and distributed between February 1999 and April 2013 are involved in the recalled.

The recall has been deemed a Class I by the FDA, which means that this involves a situation in which there is a reasonable probability that the use of or exposure to the violative product will cause serious adverse health consequences or death.

The GemStar Infusion System is a small, lightweight, single-channeled device made for home use, use in hospitals, or use anywhere electronic infusion is required. The GemStar is meant for use in intravenous (IV), arterial, subcutaneous, and short-term epidural infusion, and parenteral administration of general IV fluids, medications, nutritional foods, blood, and blood products.

When the GemStar Infusion pump’s loses contact with the device’s batteries, when components on the Middle Printed Wire Assembly (PWA) fails, or when the Middle PWA does not receive appropriate signals from elsewhere in the pump, power is shut off. Loss of contact may be due to a mechanical disconnect at either the positive or negative battery terminal and inappropriate or missing input signals may be due to contamination, corrosion damage, electronic defects, or keypad problems disrupting turn on/turn off signals.

If the internal AA batteries leak, contents will damage the device’s internal components, which also may cause the GemStar Infusion System to shut off with no warning and with no audible or visual alarm. This may cause therapy delay or interruption. Also, when the GemStar Lithium battery voltage level drops below 2.4 volts, an “11/004″ error is displayed and the device is rendered inoperable, which results in a delay or interruption of therapy. Device malfunction will cause erasure of infusion settings and event history logs.

The clinical impact of a delay and/or interruption in therapy depends on the patient’s condition and the product being infused. Because of this, a delay or interruption of therapy involving the GemStar Infusion system may potentially result in significant injury or death. Hospira notified health care professionals of the Class I recall and advised that they are to weigh the risks and benefits to patients before using the device to administer critical therapies. Use of an alternative product should be considered, particularly in those patients in which a therapy delay or interruption could result in significant injury or death.

The customer notification letter stated that lithium batteries older than three years should be replaced and that the Hospira Advanced Knowledge Center may be reached, toll-free, at 1.800.241.4002 (option 4), 24 hours a day/seven days a week, to determine if a system’s battery needs to be replaced and if return of the device to perform battery replacement is required. Facilities that periodically retrieve the history logs from their GemStar Infusion System should consider retrieving them more often to reduce the amount of history log information that would be lost should failure occur. Hospira said, “In the event that your facility’s ability to administer proper care is severely impacted by this issue, Hospira will provide loaner devices,” according to MedScape.

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