The actual device was not available; however, photographs and a video of the sample were provided for evaluation.Visual inspection of the provided photos showed the filter of the set was disconnected from the support plate to the level of the dialysate port.The reported condition of damage was verified.The damage was the cause of the reported leak.The cause of the damage was due to a transportation issue.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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It was reported that during priming with a prismaflex tpe2000 set, an external fluid leak was observed at the ¿back-bottom connection¿ to the set cartridge, due to the set cartridge was ¿broken¿.There was no patient involvement reported.No additional information is available.
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