Spontaneous call from the patient stating that the backup pump had failed.Patient was sent to the hospital.While at the hospital, the failed pump was restarted by (b)(6).There was minimal interruption to therapy.Pump did not need to be replaced.No further intervention was needed.No further information is known.Serial number of pump: (b)(4).The fault did occur while in use.The patient did not have any ill effects or clinical injury.No intervention was needed or provided to/for the patient.The device will be available to investigate once (b)(6) gets it back from the patient.Did we [mfr] replace device? yes; did the pt have a backup device 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.Reported to (b)(6) by pt/caregiver.
|