Spoke with the pt who has all cassettes defected.Lot# 4315908, 4321040, 4235242 and 4226242.Patient was dealing with pump alarming for the last few months.Patient reported yesterday that she felt a race heart beat and dizziness.Advised her to seek an immediate medical attention.No further info.Iv remodulin pt.No add'l info, details, or dates available.Pump return tracking info is not available.Photographs were not provided.This is a continuous infusion.Setflow rate and volume delivered are unk.Position of the pump when alarm occurred is unk.Did the reported product fault occur while in use with the pt? no; did the product issue cause or contribute to pt or clinical injury? no; is the actual cassette available for investigation? yes; did we [mfr] replace the cassette? yes; did the pt have add'l cassettes they were able to switch to? no; if no, what was the pt instructed to do in able to continue their infusion? yes; is the infusion life sustaining? yes; what is the outcome of the event? resolved.Reported to (b)(6) by pt/caregiver.
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