BAXTER HEALTHCARE CORPORATION PRISMAFLEX SETS (ST); DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
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Catalog Number 955596 |
Device Problems
Fluid/Blood Leak (1250); Material Split, Cut or Torn (4008)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/11/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Prismaflex st150 set c has been temporarily approved for use in the us under emergency use authorization (b)(4) to deliver crrt to treat patients in an acute care environment during the covid-19 pandemic.H10: the actual device was not available; however, a photograph and video of the sample were provided for evaluation.Visual inspection revealed that the return line is perforated.The reported leak is due to the observed line perforation.The reported condition was 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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Event Description
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It was reported that during priming, one unit of prismaflex st150 set c set had an external fluid leakage from the return line.The return line had a cut.There was no patient involvement.No additional information is available.
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Search Alerts/Recalls
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