Class 1 Recall: Hospira Inc., GemStar Infusion System - Damage from Battery Leakage
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
Power can be lost when the pump loses contact with the batteries, or when components on the Middle Printed Wire Assembly (PWA) fail, or when the Middle PWA does not receive appropriate signals from elsewhere in the pump. Loss of contact can be due to a mechanical disconnect at either the positive or negative battery terminal. Inappropriate or missing input signals can be due to contamination, corrosion damage, electronic defects or keypad problems disrupting turn on/turn off signals.
If the internal AA batteries leak, their contents will cause damage to the device’s internal components which 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 or interruption in therapy.
The clinical impact of a delay and/or interruption in therapy is dependent upon the clinical condition of the patient and the product being infused. Therefore, a delay/interruption in therapy can potentially result in significant injury or death.
Health care professionals are advised to weigh the risks and benefits to patients before using the device to administer 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.