|
Lot Number 4157445 |
Device Problem
Protective Measures Problem (3015)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Type
malfunction
|
Event Description
|
Spontaneous call from patient to report faulty cassette.Patient states he had no disposable alarm on cadd legacy pump.He went to back up pump with same cassette and had same error message.He mixed a new cassette and error resolved.No interruptions in therapy or adverse events resulted.Cassette is available for investigation.Error occurred while in use with the patient.Did the reported product fault occur while in use with the pt? yes; did the product issue cause or contribute to pt or clinical injury? no; is the actual device available for investigation? yes; did we [mfr] replace the device? yes; did the pt have a backup device they were able to switch to? yes; was the pt able to successfully continue their infusion? yes.Reported to (b)(6) by pt/caregiver.
|
|
Search Alerts/Recalls
|
|
|