BAXTER HEALTHCARE CORPORATION OXIRIS S; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
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Catalog Number 955503 |
Device Problem
Air/Gas in Device (4062)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 02/21/2022 |
Event Type
Injury
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Event Description
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It was reported that during continuous renal replacement therapy (crrt) with three oxiris sets and a prismax machine, air was reported to have entered the entire oxiris set.After each event, treatment was discontinued and the set "had to be primed again." the air detection alarm was generated, and no defects were observed on the sets.The extracorporeal blood was not returned to the patient which resulted in a 600 ml blood loss.The patient received a blood transfusion and albumin.No additional information is available.
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Manufacturer Narrative
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A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.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.Oxiris set has been temporarily approved for use in the us under emergency use authorization eua(b)(4) with a specific indication to treat patients with covid-19 infection.
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Search Alerts/Recalls
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