Catalog Number 955467 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Patient Involvement (2645)
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Event Date 12/08/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Initial reporter facility name: (b)(6) university.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 m150 set, an external fluid leakage from the dialysate port was observed.There was no patient involvement.No additional information is available.
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Manufacturer Narrative
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H10: the actual device was not available; however, a photograph and a video of the sample was provided for evaluation.The visual inspection of the provided picture showed an external fluid leak at the level of the dialysate port.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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