Catalog Number 115269 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Blood Loss (2597)
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Event Date 01/22/2021 |
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 using a prismaflex control unit, an alarm related to general malfunction was generated.The treatment was ended without the extracorporeal blood being returned to the patient.The patient lost an estimated 189 ml of blood and required a transfusion.No additional information is available.
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Manufacturer Narrative
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Additional information added to h10.H10: a service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event.The device was not received for evaluation; 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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