H10: the device was evaluated on site by a qualified technician.During the visual inspection, the qualified technician observed that the blackbox analysis showed that the ultrafiltration (uf) cell and ultrafiltration supervision (ufs) were not aligned as there was a difference of 200 to 300 ml/min between the two values.Further checking, the qualified technician found the uf cell was faulty.To resolve the issue, the qualified technician replaced the uf cell and a simulated test checked the residual value in the measuring glass and found it within the limit and the device was returned to clinical use.The reported condition was verified.The cause was uf out of calibration.Review of complaints and service history for the machine involved in this complaint determined that other four (4) similar events occurred on this machine.Based on the investigation of this complaint and on the review of the manufacturing records, it can be concluded that the cause leading to the last four (4) events of excessive weight loss was highly likely related to one of the electrovalves diva/byva/tava that internally leaked affecting the taration of the uf cell.This was also confirmed by the fact that, after the last complaint in which those electrovalves were replaced, no other similar event occurred on this machine.Should additional relevant information become available, a supplemental report will be submitted.
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