BAXTER HEALTHCARE CORPORATION PRISMAFLEX SETS (TPE); SEPARATOR FOR THERAPEUTIC PURPOSES, MEMBRANE AUTOMATED BLOOD CELL/PLASMA
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Catalog Number 107144 |
Device Problems
Fluid/Blood Leak (1250); Material Rupture (1546)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/11/2023 |
Event Type
malfunction
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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 during treatment with therapeutic plasma exchange (tpe) using a prismaflex tpe2000 set, a blood leak detection alarm was generated.Five minutes after the start of therapy, the machine presented a blood leak alarm and there was evidence of a clear rupture of membranes which lead to the internal blood leak.To resolve this issue, the therapy was stopped, and therapy was restarted with a new set.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
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Manufacturer Narrative
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B5: upon follow up, the total volume of blood lost was 0.5ml.H10: the actual device was not available; however, photographs were provided for evaluation.During visual inspection, blood was observed in the effluent fluid.The provided photo of the filter shows it connected to the machine during treatment with blood visible in the plasma water.This allowed to confirm an internal blood leak rather than an external leak as reported initially.The reported condition was verified.However, due to the nature of the provided samples, no further testing could be performed.Therefore, 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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