Catalog Number 107493 |
Device Problem
Protective Measures Problem (3015)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/24/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(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 prismaflex control unit, an air in blood alarm was generated.Treatment was discontinued without returning the extracorporeal blood to the patient.It was reported the ¿patient has lost blood 4 times in the last two days¿ (no further details provided).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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Additional information h6/h10: h10: a service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event.Should additional relevant information become available, a supplemental report will be submitted.
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Manufacturer Narrative
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Correction: removal of information in section f related to importer: the initial report inadvertently included the importer report number.This mdr should have been submitted only with the mfr.Number (and not as importer).
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Search Alerts/Recalls
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