Patient reported she has 8 cassettes affected by recall, lot: 4321040, expiration date unknown.Patient does not have any cassettes on hand that are not affected by recall.Explained recall to patient and patient said that she has been feeling awful for the last month.Nausea, diarrhea, vomiting, headache, and swelling in her legs.Patient said she also has been having difficulty breathing.Advised patient that since she did not have any cassettes not affected by recall and she is having symptoms that we recommend going to the er.Patient at first sounded like she was going to go but then said she could not leave work.Patient is refusing er right now after multiple attempts to encourage her to go.Communicated issue to md.Exact start date of events is unknown.No other information known.Pump return tracking information is not applicable to event.Photographs were not provided.This is a continuous infusion.Set flow rate and volume delivered are unknown.Position of pump when alarm occurred is not applicable.No additional information is available at this time.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? yes.If yes, was any medical intervention provided? pt.Was encourage to go to er.Is the actual product available for investigation? no.Did we replace the product? yes.Did the patient have a backup product they were able to switch to? no.Was the patient able to successfully continue their therapy? with impacted cassette.Reported to (b)(6) by: patient/caregiver.
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