BAXTER HEALTHCARE CORPORATION REVACLEAR; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
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Catalog Number 114745L |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 03/17/2023 |
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 two (2) internal blood leaks were observed in a revaclear 300.Forty minutes into hemodialysis therapy, the unspecified hemodialysis machine alarmed internal blood leak.The patient lost 250ml of blood.The patient was restarted on a new machine and new revaclear (from the same lot).Again 40 minutes into therapy, the machine alarmed internal blood leak.The patient lost another 250ml of blood.The patient was set up with a new machine and a revaclear from a different lot number.Therapy was completed with no issues.The following day, the patient underwent a blood transfusion.No additional information is available.
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Manufacturer Narrative
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Additional information: h6 and 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; 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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