Catalog Number 114746M |
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 12/24/2022 |
Event Type
malfunction
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Event Description
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It was reported that during priming with a revaclear set, an external fluid leak in the arterial side was observed.It was further reported a small rupture was noted.There was no patient involvement.No additional information is available.
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Manufacturer Narrative
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Initial reporter first name: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.
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Manufacturer Narrative
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The actual device was not available; however, a video of the sample was provided for evaluation.Visual inspection of the provided video showed the dialyzer had been primed and there was no external fluid outside of the dialyzer.The reported condition was not 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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Search Alerts/Recalls
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