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FDA Flags Two Separate Class I Corrections for Hospital Infusion Pumps That Deliver Chemotherapy and Antibiotics
['Elena Vega']
Medical Daily
Federal regulators have posted two separate Class I actions involving the same family of hospital infusion pumps, the machines that push chemotherapy, antibiotics, IV fluids, blood products, and pain medication into patients at a controlled rate.
An infusion pump that ignores a command or registers a phantom one can interrupt or delay therapy.
Reasonable Questions from a Hospital BedPatients and families cannot inspect a pump's software version, and they should not try.
If an infusion pump alarms repeatedly, if the screen appears to respond on its own, or if an infusion stops without explanation, tell the nurse rather than waiting for the next check.
The FDA states that both July issues are separate from the February software correction, even though they affect the same devices.