The FDA has issued a Class 1 recall of various modules of Cardinal Health's Alaris system electronic infusion pumps. The device delivers controlled amounts of medications or other fluids to patients through an IV, intra-arterial, epidural and other routes of administration.
The Dublin, Ohio-based company initiated the recall after identifying five problems that affected Alaris, including failure of the occlusion warning message, syringe volume warning message, electrostatic discharge protection circuitry and fluid ingress tubing.
According to the agency, it was determined that the five failures may result in patients experiencing under- or over-infusion which may result in serious injury or death. The device is intended for use with adult and pediatric patients in hospitals, including critical-care units, emergency rooms, outpatient surgical centers, hospices and nursing homes.
Specifically, the following are potential risks of the system:
- Failure of the occlusion warning message to adequately guide users to clear occluded IV tubing may result in under infusion;
- When the Alaris PC unit is used with the PCA module, the pump verifies that the programmed infusion can be delivered with the volume of therapy in the pump. If the programmed infusion rate exceeds the volume of therapy in the pump, the PC unit displays a syringe volume warning message. If the clinician ignores the warning, proceeds with the infusion and the patient presses the button to request more therapy, the pump may inject the contents of the syringe into the patient, resulting in over-infusion.
- Failure of the electrostatic discharge protection circuitry can cause: the key pad to be unresponsive; key entries without key presses; or key entries to register incorrectly. The malfunctions may result in under or over-infusion.
- Failure of an IV tubing may result in fluid entering the pumping mechanism, resulting in an over-infusion of therapy.
The company is updating their instructions for Alaris use to require inspection of the IUI connectors for blue or green corrosion before every use of the device.