Spontaneous call from patient for (b)(6) 2021 high pressure on both pumps, patient went to the er and a fibrin clot was removed from hickman line.Md informed.No further information provided.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? yes; is the actual device available for investigation? unknown; did we [mfr] replace device? unknown; did the patient have a backup device they were able to switch to? unknown.Patient went to er is the infusion life-sustaining? yes; what is the outcome of the event? unknown.Reported to (b)(6) by pt/caregiver.
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