Investigations findings to date indicated the reported malfunction occurred during recirculation and prime (machine set-up), and not during dialysis mode.The user visually observed the saline bag refilling with dialysate during circulation.There have been no adverse events associated with the reported issue.The report is being investigated by the manufacturer via a capa.The investigation is pending; a supplemental mdr will be filed at the completion of the investigation.Related mdr: 2937457-2014-00213.
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