The FDA has republished a Class 1 recall, the most serious, for the Hospira Inc. GemStar Infusion System.
The GemStar pump by Hospira is designed to deliver fluids via IV, to lower back or spinal areas, and in other parts of the body. It is small, lightweight and can be portable when using battery power. Designed for use in the hospital, home, or other settings, the electronic infusion system can deliver medications, nutrition, and blood or blood products.
The FDA states that the pump can fail, potentially leading to serious injury or death. The sensors and calibration (adjustments) of the pump may not accurately detect the needed pressure and cause a blockage or inadequate supply of the infusion. By delaying, interrupting or over-delivering the flow of the fluids being pumped, the FDA says the device has the “worst-case potential to result in significant injury or death.”
Physicians are being notified to weigh the risk/benefit of using the device and to use an alternative if the patient would be harmed by the intermittent or stopped flow.
Although the recall was instituted earlier this year the FDA has reissued the notice in hopes of reaching all affected patients, who can follow the steps on the webpage link below to learn the affected models and how to test their system for potential failure or malfunction.
Harman Law LLC is currently representing patients and families of patients across the country who have been injured or died while on several types of infusion pumps. The firm’s attorneys advise patients and family members of the steps to take if a pump has failed or malfunctioned, including keeping the pump for inspection before returning to the doctor or manufacturer.
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