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Device Problem
Device Alarm System (1012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/01/2023 |
Event Type
malfunction
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Manufacturer Narrative
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(udi) is unknown; no further information was provided.No lot number was provided; therefore, a device history record (dhr) review could not be conducted.No product was returned; therefore, no visual and functional tests were performed, the reported complaint could not be confirmed, and the root cause could not be determined.
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Event Description
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It was reported that the pump alarmed 'no disposable clamp tubing'.Upon restart, pump alarmed 'no disposable, pump won't run'.Settings were reviewed, pump turned off and tubing clamped.Cassette removed and tubing massaged while pressing green flow stop down.Air bubbles were present in the cassette tubing.Cassette tapped on a hard surface and attached.Pump turned on, settings reviewed and upon restart, alarm returned.Process was repeated and alarm persists.Patient not affected.No patient injury reported.
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Search Alerts/Recalls
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