Catalog Number 955558 |
Device Problem
Audible Prompt/Feedback Problem (4020)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/13/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Alternate reporter phone no.: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.
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Event Description
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It was reported that during continuous renal replacement therapy (crrt) with a prismax control unit, a "b1116 : return pressure self - test fail" alarm was generated twice during therapy.Two treatments ended without the extracorporeal blood (ec) being returned to the patient.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
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Manufacturer Narrative
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The device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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