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Lot Number 4052410 |
Device Problems
Device Alarm System (1012); Defective Device (2588)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/06/2021 |
Event Type
malfunction
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Event Description
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Spontaneous call.Patient called with 'no disposable' alert on both the main pump and back up pump.Advised patient that highly unlikely that both pumps would have the same problem.Instructed patient to mix a new solution with a new cassette with a different lot number.Patient did as instructed.No more alarms.Defective cassette: 4052410.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? no.Is the actual device available for investigation? yes.Did we replace the device? no.Did the patient have a back up device they were able to switch to? yes.If yes, was the patient able to successfully continue their infusion? yes.Is the infusion life-sustaining? yes.Reported to (b)(6) by pt/caregiver.
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Search Alerts/Recalls
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