Catalog Number 114748 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Patient Involvement (2645)
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Event Date 10/07/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Facility name: (b)(6) hospital.Phone number: (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 revaclear 300, a particulate matter was observed inside the fluid pathway.There was no patient involvement.No additional information is available.
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Manufacturer Narrative
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Corrected information: a nonconformance has been opened to address this issue.Should additional relevant information become available, a supplemental report will be submitted.
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Manufacturer Narrative
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H10: the actual device was not available; however, a photograph of the sample was provided for evaluation.The visual inspection of the provided photo showed the product dry and with two particles on the dialysate side.The reported failure was verified.The cause was manufacturing related.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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