Catalog Number CL 10021021 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/08/2015 |
Event Type
malfunction
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Event Description
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A hemodialysis user facility has reported that during treatment a blood leak occurred at the bottom connection of the crit-line blood chamber that threads to the dialyzer.The leak was visually observed to be an external leak below the wings of the pvc adapter around the threaded area that connects to the dialyzer.Estimated blood loss was no more than 30cc.The patient had no adverse effects and no medical intervention was required.The patient completed treatment.Sample has not been returned to manufacturer for evaluation.
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Manufacturer Narrative
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Plant investigation has not yet been completed.A follow up report will be filed upon completion of the investigation.
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Manufacturer Narrative
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Updated the occurrence date.
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Manufacturer Narrative
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The device was not returned to the manufacturer for physical evaluation.A product recall has been initiated by the manufacturer and the reported product issue is being investigated by the manufacturer via a capa.
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Search Alerts/Recalls
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