Catalog Number 114745L |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Hemolysis (1886)
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Event Date 08/04/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(6).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 a patient undergoing dialysis treatment with a cartridge bloodline and revaclear 300 dialyzer experienced hemolysis.At an unknown time during treatment, the extracorporeal circuit clotted and the treatment was terminated with a blood loss of less than 100 ml.The treatment was later restarted and completed.The patient was hospitalized for monitoring as hemolysis was suspected to have occurred during the first treatment.There was no medical intervention during hospitalization.The patient was reported to be in stable condition at the time of this report.No additional information is available.
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Manufacturer Narrative
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The sample was receive by baxter for evaluation.A blood leak test (opl-wins-1257) was performed and it failed.The leak was verified from inside the fiber bundle on the dmc side of the dialyzer.All other parameters for fiber inspection passed.There were no issues with the gasket position and/or pur defects.The retained sample was tested as well, and it passed all parameters of inspection.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.The device was manufactured between 30jun2018 through 03jul2018.
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Search Alerts/Recalls
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