LIBERTY SELECT CYCLER ASSY(NON-VALUATED)
Report
- Report Number
- 0008030665-2025-01397
- Event Type
- Death
- Date Received
- June 18, 2025
- Date of Event
- May 31, 2025
- Report Date
- July 21, 2025
- Manufacturer
- ERIKA DE REYNOSA, S.A. DE C.V.
- Product Code
- FKX
- UDI-DI
- 00840861102068
- PMA / PMN Number
- K181108
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
ADDITIONAL INFORMATION: D.10., H.3. PLANT INVESTIGATION: THE ACTUAL DEVICE WAS RETURNED TO THE MANUFACTURER FOR PHYSICAL ANALYSIS. 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. THERE WERE VISUAL INDICATIONS OF PARTICULATES WITHIN THE CASSETTE AREA. THERE WERE NOT BURRS OR SHARP EDGES IN CASSETTE AREA THAT MAY HAVE PUNCTURED A CASSETTE MEMBRANE. VALVE ACTUATION TEST PASSED. SYSTEM AIR LEAK TEST PASSED. MUSHROOM HEAD CHECK PASSED. A SIMULATED TREATMENT USING (AS-RECEIVED) TREATMENT SETTINGS WITH REDUCED DWELL TIMES WAS PERFORMED AND COMPLETED WITHOUT FAILURES. NO FLUID LEAKS IN THE TEST CASSETTE DURING THE TREATMENT TEST. THE DEVICE HISTORY RECORD DID NOT REVEAL ANY ISSUES OR PROBLEMS RELATED TO THE REPORTED SYMPTOM CODE(S). UPON COMPLETION OF THE EVALUATION, THERE WERE NO MALFUNCTIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. AN ASSOCIATED CAUSE COULD NOT BE DETERMINED.
CLINICAL REVIEW: A TEMPORAL RELATIONSHIP EXISTS BETWEEN CCPD THERAPY UTILIZING THE LIBERTY SELECT CYCLER AND THE PATIENT¿S DEATH. THE CAUSE OF THIS PATIENT¿S DEATH CAN BE ATTRIBUTED TO COMPLICATIONS FROM A PRIOR CEREBRAL VASCULAR ACCIDENT (CVA), CARDIAC INSUFFICIENCY AND MULTIMORBIDITY AS REPORTED BY A MEDICAL PROFESSIONAL. IT IS WELL KNOWN THE ESRD POPULATION CONTINUES TO HAVE SIGNIFICANTLY HIGHER MORTALITY, AND FEWER EXPECTED YEARS OF LIFE WHEN COMPARED TO THE GENERAL POPULATION, PARTICULARLY IN THE ENVIRONMENT OF CARDIOPULMONARY DISEASE. THEREFORE, THE LIBERTY SELECT CYCLER CAN BE EXCLUDED AS A ROOT CAUSE OR CONTRIBUTOR TO THIS PATIENT¿S ADVERSE EVENT. BASED ON THE AVAILABLE INFORMATION, THERE IS NO SPECIFIC ALLEGATION OR OBJECTIVE EVIDENCE INDICATING A FRESENIUS DEVICE(S) OR PRODUCT(S) DEFICIENCY OR MALFUNCTION, CAUSED OR CONTRIBUTED TO THE PATIENT¿S ADVERSE EVENTS. THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.
A REGISTERED NURSE REPORTED TO FRESENIUS CUSTOMER SERVICE THIS PERITONEAL DIALYSIS (PD) PATIENT ON CONTINUOUS CYCLIC PD (CCPD) THERAPY UTILIZING THE LIBERTY SELECT CYCLER EXPIRED WHILE CONNECTED TO THE CYCLER. THERE WAS NO SPECIFIC ALLEGATION THAT THIS EVENT WAS DUE TO A DEFICIENCY OR MALFUNCTION OF ANY FRESENIUS PRODUCT(S) OR DEVICE(S) IN THE INITIAL REPORTING. UPON FOLLOW-UP WITH THE PATIENT¿S PD REGISTERED NURSE, IT WAS REPORTED THIS PATIENT EXPIRED ON (B)(6) 2025 AT HOME DUE TO COMPLICATIONS FROM A PRIOR CEREBRAL VASCULAR ACCIDENT (CVA), CARDIAC INSUFFICIENCY AND MULTIMORBIDITY. IT WAS AFFIRMED THAT THE PATIENT WAS CONNECTED TO HER LIBERTY SELECT CYCLER AT THE TIME OF DEATH. THE PATIENT¿S FAMILY WAS ALERTED TO AN ALARM FROM A GLUCOSE MONITORING SYSTEM (NOT A FRESENIUS PRODUCT) THAT STATED THERE WAS NO BLOOD FLOW FOR TESTING. THE PATIENT WAS FOUND PULSELESS AND UNRESPONSIVE WHEN EMERGENCY MEDICAL SERVICES (EMS) WERE ACTIVATED. THE PATIENT WAS GIVEN CARDIOPULMONARY RESUSCITATION AND ADVANCED CARDIAC LIFE SUPPORT BY EMS PERSONNEL; HOWEVER, THE PATIENT SUCCUMBED TO HER ILLNESS, AND SHE WAS PRONOUNCED DECEASED IN THE FIELD WITH NO TRANSPORT TO HOSPITAL. IT WAS CONFIRMED THAT THE PATIENT¿S PREVIOUS CVA AND CARDIAC INSUFFICIENCY WERE UNRELATED TO PD THERAPY. ADDITIONALLY, IT WAS CONFIRMED THE PATIENT¿S MULTIMORBIDITY AND HER SUBSEQUENT DEATH WERE NOT DUE TO A DEFICIENCY OR MALFUNCTION OF ANY FRESENIUS PRODUCT(S) OR DEVICE(S).
A REGISTERED NURSE REPORTED TO FRESENIUS CUSTOMER SERVICE THIS PERITONEAL DIALYSIS (PD) PATIENT ON CONTINUOUS CYCLIC PD (CCPD) THERAPY UTILIZING THE LIBERTY SELECT CYCLER EXPIRED WHILE CONNECTED TO THE CYCLER. THERE WAS NO SPECIFIC ALLEGATION THAT THIS EVENT WAS DUE TO A DEFICIENCY OR MALFUNCTION OF ANY FRESENIUS PRODUCT(S) OR DEVICE(S) IN THE INITIAL REPORTING. UPON FOLLOW-UP WITH THE PATIENT¿S PD REGISTERED NURSE, IT WAS REPORTED THIS PATIENT EXPIRED ON (B)(6) 2025 AT HOME DUE TO COMPLICATIONS FROM A PRIOR CEREBRAL VASCULAR ACCIDENT (CVA), CARDIAC INSUFFICIENCY AND MULTIMORBIDITY. IT WAS AFFIRMED THAT THE PATIENT WAS CONNECTED TO HER LIBERTY SELECT CYCLER AT THE TIME OF DEATH. THE PATIENT¿S FAMILY WAS ALERTED TO AN ALARM FROM A GLUCOSE MONITORING SYSTEM (NOT A FRESENIUS PRODUCT) THAT STATED THERE WAS NO BLOOD FLOW FOR TESTING. THE PATIENT WAS FOUND PULSELESS AND UNRESPONSIVE WHEN EMERGENCY MEDICAL SERVICES (EMS) WERE ACTIVATED. THE PATIENT WAS GIVEN CARDIOPULMONARY RESUSCITATION AND ADVANCED CARDIAC LIFE SUPPORT BY EMS PERSONNEL; HOWEVER, THE PATIENT SUCCUMBED TO HER ILLNESS, AND SHE WAS PRONOUNCED DECEASED IN THE FIELD WITH NO TRANSPORT TO HOSPITAL. IT WAS CONFIRMED THAT THE PATIENT¿S PREVIOUS CVA AND CARDIAC INSUFFICIENCY WERE UNRELATED TO PD THERAPY. ADDITIONALLY, IT WAS CONFIRMED THE PATIENT¿S MULTIMORBIDITY AND HER SUBSEQUENT DEATH WERE NOT DUE TO A DEFICIENCY OR MALFUNCTION OF ANY FRESENIUS PRODUCT(S) OR DEVICE(S).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 788807 | LIBERTY SELECT CYCLER ASSY(NON-VALUATED) | SYSTEM, PERITONEAL, AUTOMATIC DELIVERY | FKX | ERIKA DE REYNOSA, S.A. DE C.V. | 00840861102068 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Male | Death | DELFLEX PD FLUID| DELFLEX PD FLUID| LIBERTY CYCLER SET| LIBERTY CYCLER SET |