Catalog Number 103579 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/20/2021 |
Event Type
malfunction
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Manufacturer Narrative
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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 upon starting treatment with a polyflux 170h, an external dialysate leak was observed at the header.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 device was received for evaluation.The visual inspection by naked eye of the product showed the product wet.A leak test of the dialysate side was performed and a leak was observed.The cause was a crack in the welding zone.The reported condition was verified.The cause of the crack 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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