Spontaneous call.On (b)(6) 2022 spoke with patient's spouse who stated pump reads reservoir volume low with a full cassette.Patient switched to backup pump which read the same message.Patient used a new cassette and pump worked fine.Patient did not have lot number of cassette available.No other information known.Return tracking information not available.Photographs were not included.This is a continuous infusion.Setflow rate and volume delivered are unknown.Pump position unknown.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? no; did we [mfr] replace the cassette? not yet; did the pt have add'l cassettes they were able to switch to? yes; if yes, was the pt able to successfully 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.
|