Catalog Number 107144 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/05/2022 |
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 during the priming of a prismaflex tpe2000 set, "a heparinized solution outlet was identified from the medical device circuit".There was no patient involvement.No additional information is available.
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Manufacturer Narrative
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The actual sample was not received; however, photographs and a video were provided for evaluation.Visual inspection observed leakage from the access post pump line.The reported condition was 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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Manufacturer Narrative
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H10: the device was received for evaluation.Visual inspection of the set showed a hole at the screwed connector filter.The reported condition was verified.The cause of the condition could not be determined.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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