Catalog Number 955503 |
Device Problems
Disconnection (1171); Fluid/Blood Leak (1250)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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Oxiris s has been temporarily approved for use in the us under emergency use authorization (b)(4) with a specific indication to treat patients with covid-19 infection.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 approximately one hour into continuous renal replacement therapy using a prismax and a prismaflex oxiris set, a split and separated tubing occurred.This resulted to an external blood leak.The amount of blood loss was not reported.There was no patient injury or medical intervention associated with this event.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 of the sample was provided for evaluation.The visual inspection of the provided picture showed an external blood leak at the level of the replacement pump segment and that the replacement pump segment was observed to be disconnected from the support plate on one site.The reported condition 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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