"ivt" call transferred from (b)(6), psr.Spoke with pt regarding cassette issue.Pt reported that he has 12 cassettes of 3 different defective lot numbers 3891159, 4321040, and 4298336.Pt has 1 cassette with lot# 4329622.Reviewed pt to use only that cassette until order is delivered on 12/20/2022.Patient reported change in breathing "felt like medication not doing it's thing'' did the reported product fault occur while in use with the patient? yes.Did the product issue cause or contribute to patient or clinical injury?change in breathing; if yes, was any medical intervention provided? no is the actual product available for investigation? yes.Pump return tracking info is not applicable to event.Photographs were not provided.This is a continuous infusion.Set flow rate and volume delivered are unk.Position of pump when alarm occurred is not applicable.No add'l info is available at this time.Reported to (b)(6) by pt/caregiver.
|