Catalog Number 955608 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/02/2020 |
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 30 minutes after starting treatment with a polyflux 140h, an external blood leak from the arterial header was observed.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 of the product with the naked eye observed the product to be wet.A leak test of the dialysate side was performed and a crack was found in the welding zone.A leak test on the blood side was perfomed and no defect could be found.Additionally a leak test was performed with blood and a leak was observed with a tmp of 200 mmhg.The reported condition was verified.The cause of the leak was a pur residue that was between the pur surface and the o-ring.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.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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Search Alerts/Recalls
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