It was reported that the patient was mixing new cassette but pump kept alerting for high pressure during priming.Daughter stated she tried to troubleshoot by disconnecting and reconnecting, turning off and on pump but unable to resolve; patient's daughter stated.Mixed a new cassette and had no further issues.Patient daughter stated patient was still connected to old.Pump and cassette so patient did not stop infusing and had no gaps in therapy; patient stated she does not have serial number of cassette as she had already thrown the malfunctioned cassette away; advised for future to hold on to any malfunctioned cassettes; daughter also mentioned that patient experiencing an increase in diarrhea, swelling.And has been noticing some diminished taste; discussed side effects of medication and when to seek medical attention; advised f/u with mdo as well; patient daughter verbally understood; patient uses iv remodulin with pump.No other information known.The reported product fault did not occur while in use with the patient.The product issue did not cause or contribute to patient or clinical injury.The actual cassette is not available for investigation.The manufacturer replaces the device.Patient they were able to switch to and was able to successfully continue their infusion.The infusion is life sustaining.The outcome of the event was resolved.
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No product was returned.The investigation determined the most probable cause to be the dso sensor, however this cannot be confirmed as no product was returned for investigation.If the product is returned this complaint will be reopened for further investigation.No serial number was provided; therefore, a history record review could not be conducted.D4: model number, catalog number, serial number, udi, g5, and h4 are unknown.
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