Catalog Number 955626 |
Device Problem
Device Alarm System (1012)
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Patient Problem
Blood Loss (2597)
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Event Date 12/12/2020 |
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 a continuous renal replacement therapy treatment with a prismax machine, a system failure and all service alarm were generated.Treatment had been running "for a while".The treatment was interrupted and the extracorporeal blood was not returned to the patient.Treatment was restarted with 2 other prismax machines, resulting in additional blood loss and a blood transfusion.The patient outcome was not reported.No additional information is available.
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Manufacturer Narrative
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Correction: removal of information in section f related to importer - the initial report inadvertently indicated that the report was being submitted as an importer report.This mdr should have been submitted only as a manufacturer report (and not as an importer report).
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Manufacturer Narrative
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H9: 3003504604-04/21/21-001-c.H10: the device was inspected on site by a qualified baxter technician and the arps (automatic repositioning system segment) was replaced.A device history review revealed no issues that could have caused or contributed to the reported issue.The lox files were reviewed and the reported condition was verified.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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