BAXTER HEALTHCARE CORPORATION POLYFLUX 140H; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
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Catalog Number 955608 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/30/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Initial reporter phone no.: (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 five minutes after starting treatment with a polyflux 140h, an external blood leak at the arterial header was observed.There was patient involvement however, no patient injury or medical intervention was reported.No additional information is available.
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Manufacturer Narrative
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Additional information added to d9, h3, h6, h10 h10; the actual device was received for evaluation.The visual inspection by naked eye of the product did not show any conspicuousness.A leak test of the blood side and the dialysate side was performed and no leak was observed.A leak test with bovine blood was performed and no leak was observed.The reported condition was not verified.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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