Investigation findings to date indicated the reported malfunction occurred during recirculation and prime (machine set-up), and typically not during dialysis mode.The saline bag refilling with dialysate was generally observed visually during recirculation.There have been no adverse events associated with the reported issue.The device was not returned to the mfr for physical eval and the failure mode cannot be confirmed.The customer replaced valve v43, but the parts were not returned for investigation.However, an investigation of the device mfg records was conducted by the mfr.There were no deviations or non-conformances discovered during the mfg process.In addition, the batch record review confirmed the labeling, material, and process controls were within spec.
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