Catalog Number 107144 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Patient Involvement (2645)
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Event Date 01/13/2020 |
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 during priming with a prismaflex tpe2000, a leak was observed at the luer lock of the access line and the dialyzer.There was no patient involvement.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 provided sample showed that the filter was disconnected from the support plate.This disconnection is considered to be due to the sample shipping process given that no such damage was reported.A leak test was performed on the return and access lines and no leak was observed.The reported condition was not verified.The cause 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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