Catalog Number 955470 |
Device Problems
Break (1069); Fluid/Blood Leak (1250)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/04/2021 |
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 that during priming with a prismaflex tpe2000 set, an external fluid leakage was observed due to a damaged tube.There was no patient involvement.No additional information is available.
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Manufacturer Narrative
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H10: the device was not received for evaluation however photos were provided.The visual inspection observed that the bld tube of the effluent line was perforated.The reported condition was verified.The cause 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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