BAXTER HEALTHCARE CORPORATION PRISMAFLEX SETS (M); DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
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Catalog Number 955467 |
Device Problems
Break (1069); Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/16/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Initial reporter address: (b)(6).The actual device was not available; however, a photograph of the sample was provided for evaluation.Their visual inspection observed that the cone of the return male luer lock (mll) was broken.The reported condition was verified.This is a design related issue.A nonconformance has been opened to address this issue.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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Event Description
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It was reported that during use, one unit of prismaflex m150 set c had an external fluid leak at the venous end.The nipple of the venous port was observed to be broken.There was patient involvement however, no patient injury or medical intervention was reported.No additional information is available.
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Search Alerts/Recalls
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