BAXTER HEALTHCARE CORPORATION POLYFLUX; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
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Catalog Number 112466 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/20/2022 |
Event Type
malfunction
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Event Description
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It was reported that during priming with a polyflux 170h, an external fluid leak was observed.The set was changed, and treatment was completed without issue.There was no patient involvement.No additional information is available.
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Manufacturer Narrative
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The actual device was not available; however, two photographs of the sample were provided for evaluation.Visual inspection of the provided pictures showed the product wet in photo one and the product label in the second photo.The reported condition was not verified.The cause of the condition could not be determined.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.
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Search Alerts/Recalls
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