Spontaneous.Patient reporting both of the cadd legacy pumps (serial numbers (b)(4)) are not priming.Pt is pressing and holding the prime button, but it is not responding and the three dashes not appearing.Pt checked the lock code and it is "ii1".Advised patient to go to the hospital.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? unknown.Is the actual device available for investigation? yes.Did we replace device? yes.Did the patient have a backup device they were able to switch to? no.Was the patient able to successfully continue their therapy? no.If no, what was the patient instructed to do in able to continue their infusion? go to the hospital.Is the infusion life-sustaining? yes.What is the outcome of the event? ongoing.Reported to (b)(6) by pt/caregiver.
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