Catalog Number 955558 |
Device Problem
Device Alarm System (1012)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 12/17/2021 |
Event Type
Injury
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Manufacturer Narrative
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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 with a prismax control unit via extracorporeal membrane oxygenation, an alarm condition related to system error occurred and the screen and turned black.The treatment was ended without the extracorporeal blood being returned to the patient.The amount of blood loss was not reported.The patient became ¿circulatory unstable¿ and needed an erythrocyte concentrate.The patient outcome was not reported.No additional information is available.
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Manufacturer Narrative
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H10: the actual device was evaluated on-site by a qualified technician.The black screen occurred after the b1541: ¿effluent pod reposition failure¿ alarm.The reported condition was verified.The cause was a component failure.The effluent pressure pod was replaced.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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