On Monday, FDA regulators once again issued their highest-risk Class I status on a recall of Hospira’s GemStar portable infusion systems. Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
A portable infusion system is used to pump medicines intravenously on an automatic basis. The GemStar systems are designed for infusion of epidurals, I.V. fluids, medications, blood and other therapeutic liquids. Hopira’s GemStar models can run on AC power, from a docking station, or simply with AA batteries if patients are able to walk around with the unit.
The affected GemStar systems may fail to dispense medications, display numerous warnings, fail to detect occlusions, or show other unusual behaviors due to a defect in the pressure sensors. The recall covers six models manufactured after Jan. 1, 2009. The recall also covers any of those models that have had their pressure monitor replaced during that time.
Hospira recommends that all healthcare providers perform certain tests to determine whether the systems need to be removed from use. Potential risks associated with the recall include:
- If errors are observed, the infusion is stopped, resulting in delay/interruption in therapy.
- A full or partial occlusion may prevent fluid from reaching the patient, resulting in delay/interruption of therapy.
- An undetected distal occlusion may cause excessive pressure and fluid build-up within the distal line undetected by the pressure sensor. When the distal occlusion is resolved, the build-up fluid will be administered into the patient possibly causing a maximal over-infusion of <1.0 mL.
- The severity in 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 significant injury or death.
- Depending on the drug and the dosage delivered, over-infusion has the worst-case potential to result in significant injury or death.
This is not the 1st time that the GemStar systems have gotten the FDA’s Class I label. The recent action is tied to a recall from March of this year. The FDA also issued a Class I recall in April for concerns that battery leakage may cause the devices to shut off without warning.
At that time, Hospira advised healthcare professionals to use an alternate pump in cases where any delay or under-infusion could result in injury or death. It further recommended checking the pump’s battery compartment for signs of corrosion. Finally, Hospira advised that batteries more than 3 years old should be replaced.
If you have been injured by a defective Hospira GemStar Infusion Pump, the attorneys at JONES WARD PLC would be happy to discuss your rights with you. Please contact attorney R. Lauren Horner at firstname.lastname@example.org for more information.