BAXTER HEALTHCARE CORPORATION OXIRIS S; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
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Catalog Number 955503 |
Device Problem
Filtration Problem (2941)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Event Description
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It was reported that during continuous veno-venous hemodiafiltration (cvvhdf) with prismaflex oxiris sets, clotting was observed.The patient was treated with six oxiris sets over a 10-day period.The treatments were initially performed using regional citrate anticoagulation and were subsequently switched to heparin.Transmembrane pressure (tmp) too high alarms were generated, and large clots were observed in the oxiris sets.The extracorporeal (ec) blood was not returned to the patient; however, the patient did not present with any clinical symptom and no medical intervention was associated with this event.It was reported the patient was not acidotic or septic when the last couple of filter sets were used.At the time of this report, the patient¿s blood was stable.No additional information is available.
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Manufacturer Narrative
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The events occurred between (b)(6) 2022 and (b)(6) 2022.Oxiris s 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.Should additional relevant information become available, a supplemental report will be submitted.
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Manufacturer Narrative
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H10: 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 however, two companion samples were evaluated.A visual inspection and a pressure test was performed, no leaks were detected.The reported condition was not verified.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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