LIBERTY SELECT CYCLER ASSY(NON-VALUATED)
Report
- Report Number
- 0008030665-2025-02075
- Event Type
- Death
- Date Received
- September 2, 2025
- Date of Event
- August 21, 2025
- Report Date
- October 7, 2025
- Manufacturer
- ERIKA DE REYNOSA, S.A. DE C.V.
- Product Code
- FKX
- PMA / PMN Number
- K222318
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- 003
Narratives
ADDITIONAL INFORMATION PROVIDED IN D9 AND H3. CORRECTION PROVIDED IN G4. PLANT INVESTIGATION: A VISUAL INSPECTION OF THE RETURNED CYCLER EXTERIOR SHOWED NO SIGNS OF PHYSICAL DAMAGE. THERE WERE NO VISUAL INDICATIONS OF DRIED FLUID WITHIN THE CASSETTE COMPARTMENT ON THE PUMP. THERE WERE VISUAL INDICATIONS OF PARTICULATES WITHIN THE CASSETTE AREA. THERE WERE NO BURRS OR SHARP EDGES IN CASSETTE AREA THAT MAY HAVE PUNCTURED A CASSETTE MEMBRANE. AN (AS RECEIVED WITH REDUCED DWELL) SIMULATED TREATMENT WAS PERFORMED AND COMPLETED. VALVE ACTUATION TEST PASSED. SYSTEM AIR LEAK TEST PASSED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED BY THE MANUFACTURER. THERE WERE NO DEVIATIONS OR NON-CONFORMANCES DURING THE MANUFACTURING PROCESS. IN ADDITION, A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED AND VERIFIED THAT THE RESULTS OF THE IN-PROGRESS AND FINAL QUALITY CONTROL (QC) TESTING MET ALL REQUIREMENTS. UPON COMPLETION OF THE EVALUATION, THERE WERE NO MALFUNCTIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE CYCLER PERFORMED AS DESIGNED AND AN ASSOCIATED CAUSE COULD NOT BE DETERMINED.
THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY. CLINICAL REVIEW: A TEMPORAL RELATIONSHIP EXISTS BETWEEN PD THERAPY WITH THE LIBERTY SELECT CYCLER AND THE PATIENT¿S DEATH. HOWEVER, THERE IS NO ALLEGATION OR OBJECTIVE EVIDENCE THAT THE PATIENT¿S DEATH WAS RELATED TO A PRODUCT ISSUE OR MALFUNCTION WITH THE FRESENIUS CYCLER OR ANY ISSUES WITH PD TREATMENT. THE FRESENIUS CYCLER WAS PENDING RETURN TO MANUFACTURER AT THE TIME THIS CLINICAL INVESTIGATION WAS COMPLETED. THE PATIENT HAD A COMPLEX MEDICAL HISTORY THAT INCLUDED PRE-EXISTING ESRD ON PD THERAPY, TIA (WITH RECENT HOSPITALIZATION), CHRONIC ANEMIA, COAGULATION DEFECTS, STROKE, DIABETES MELLITUS TYPE 2 WITH LONG TERM CHRONIC USE OF INSULIN, AND HYPERTENSION. THE PATIENT¿S ESRD DEATH CERTIFICATE IS NOT AVAILABLE, AND THE EXACT CAUSE OF DEATH IS UNKNOWN. HOWEVER, PATIENTS WITH END STAGE RENAL DISEASE (ESRD) ON DIALYSIS HAVE A SIGNIFICANTLY HIGHER MORTALITY RISK THAN THE GENERAL POPULATION. ADDITIONALLY, THE PATIENT¿S PRE-EXISTING COMPLEX COMORBID CONDITIONS FURTHER INCREASE MORTALITY RISK AND ARE LIKELY CONTRIBUTING FACTORS IN THE REPORTED DEATH.
IT WAS REPORTED THIS PATIENT ON PERITONEAL DIALYSIS (PD) EXPIRED WHILE STILL CONNECTED TO THE FRESENIUS CYCLER. IN ADDITIONAL FOLLOW-UP, THE PATIENT¿S PD NURSE WAS ABLE TO CONFIRM THAT THE PATIENT EXPIRED ON (B)(6) 2025 WHILE CONNECTED TO THE FRESENIUS CYCLER IN UNKNOWN PHASE OF PD TREATMENT AT HOME. THE PD NURSE STATED THERE WERE NO ISSUES WITH THE PD TREATMENT OR ANY MALFUNCTIONS WITH THE FRESENIUS CYCLER IN RELATION TO THE DEATH. THE PATIENT¿S END STAGE RENAL DISEASE (ESRD) DEATH CERTIFICATE WAS NOT AVAILABLE AND THEREFORE THE EXACT CAUSE OF DEATH WAS UNKNOWN. HOWEVER, THE NURSE STATED THE PATIENT HAD A COMPLEX PRE-EXISTING MEDICAL HISTORY WHICH INCLUDED TRANSIENT ISCHEMIC ATTACK (TIA), CHRONIC ANEMIA, COAGULATION DEFECTS, STROKE, DIABETES MELLITUS TYPE 2 WITH LONG TERM CHRONIC USE OF INSULIN, AND HYPERTENSION. FURTHERMORE, THE NURSE STATED THE PATIENT WAS HOSPITALIZED (ON (B)(6) 2025 - UNKNOWN DATE) FOR TIA (UNRELATED TO DIALYSIS/PRODUCT AND DID NOT OCCUR DURING A PD TREATMENT). THE NURSE CONFIRMED THAT THE FRESENIUS CYCLER IS IN THE PD CLINIC PENDING RETURN TO MANUFACTURER. THE PD NURSE INDICATED THE DEATH WAS NOT SUSPECTED TO BE RELATED TO THE FRESENIUS CYCLER. THE NURSE REPORTED THAT THE DEATH IS SUSPECTED TO BE RELATED TO PATIENT¿S PRE-EXISTING PD COMPLEX MEDICAL COMORBID CONDITIONS. NO FURTHER INFORMATION ABOUT THE DEATH WAS AVAILABLE.
IT WAS REPORTED THIS PATIENT ON PERITONEAL DIALYSIS (PD) EXPIRED WHILE STILL CONNECTED TO THE FRESENIUS CYCLER. IN ADDITIONAL FOLLOW-UP, THE PATIENT¿S PD NURSE WAS ABLE TO CONFIRM THAT THE PATIENT EXPIRED ON (B)(6) 2025 WHILE CONNECTED TO THE FRESENIUS CYCLER IN UNKNOWN PHASE OF PD TREATMENT AT HOME. THE PD NURSE STATED THERE WERE NO ISSUES WITH THE PD TREATMENT OR ANY MALFUNCTIONS WITH THE FRESENIUS CYCLER IN RELATION TO THE DEATH. THE PATIENT¿S END STAGE RENAL DISEASE (ESRD) DEATH CERTIFICATE WAS NOT AVAILABLE AND THEREFORE THE EXACT CAUSE OF DEATH WAS UNKNOWN. HOWEVER, THE NURSE STATED THE PATIENT HAD A COMPLEX PRE-EXISTING MEDICAL HISTORY WHICH INCLUDED TRANSIENT ISCHEMIC ATTACK (TIA), CHRONIC ANEMIA, COAGULATION DEFECTS, STROKE, DIABETES MELLITUS TYPE 2 WITH LONG TERM CHRONIC USE OF INSULIN, AND HYPERTENSION. FURTHERMORE, THE NURSE STATED THE PATIENT WAS HOSPITALIZED (ON (B)(6) 2025- UNKNOWN DATE) FOR TIA (UNRELATED TO DIALYSIS/PRODUCT AND DID NOT OCCUR DURING A PD TREATMENT). THE NURSE CONFIRMED THAT THE FRESENIUS CYCLER IS IN THE PD CLINIC PENDING RETURN TO MANUFACTURER. THE PD NURSE INDICATED THE DEATH WAS NOT SUSPECTED TO BE RELATED TO THE FRESENIUS CYCLER. THE NURSE REPORTED THAT THE DEATH IS SUSPECTED TO BE RELATED TO PATIENT¿S PRE-EXISTING PD COMPLEX MEDICAL COMORBID CONDITIONS. NO FURTHER INFORMATION ABOUT THE DEATH WAS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 247362 | LIBERTY SELECT CYCLER ASSY(NON-VALUATED) | SYSTEM, PERITONEAL, AUTOMATIC DELIVERY | FKX | ERIKA DE REYNOSA, S.A. DE C.V. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Female | Death | DELFLEX PD FLUID| DELFLEX PD FLUID| LIBERTY CYCLER SET | LIBERTY CYCLER SET |