LIBERTY SELECT CYCLER ASSY(NON-VALUATED)

Description of Event or Problem

It was reported that this patient with end stage renal disease (ESRD) on continuous cyclic peritoneal dialysis "[CC(PD)]" utilizing a Liberty Select Cycler for renal replacement therapy (RRT) expired on (b)(6) 2026. Subsequent attempts to obtain additional clinical information (e.g., death certificate, discharge summary, ESRD Death Notification, treatment records, hospital records) were unsuccessful.

Additional Manufacturer Narrative

The plant investigation is in process. A supplemental MDR will be submitted upon completion of this activity.  Clinical Review: It is unknown if a temporal relationship exists between CCPD therapy utilizing a Liberty Select Cycler and the serious adverse event of death, as it is unknown if the patient was actively undergoing CCPD therapy when she passed away. The ESRD population continues to have significantly higher mortality, and fewer expected years of life when compared to the general population. Additionally, adults with ESRD have mortality rates up to 30-fold higher than the general population with similar comorbid conditions. It should be noted that limited clinical follow-up precluded a more comprehensive investigation. Based on the limited information available, the Liberty Select Cycler cannot be disassociated from the serious adverse event. Given the unknown cause, unknown timeline of events, lack of clinical follow-up, and no manufacturer evaluation of the patient¿s device. This clinical investigation cannot exclude the Liberty Select Cycler from having a possible causal or contributory role in the serious adverse event experienced by the patient, despite there being no allegation or objective evidence indicating a FMCRTG device(s) and/or product(s) malfunction or deficiency occurred.