LIBERTY SELECT CYCLER ASSY(NON-VALUATED)
Report
- Report Number
- 0008030665-2025-02477
- Event Type
- Death
- Date Received
- October 16, 2025
- Date of Event
- October 8, 2025
- Report Date
- November 20, 2025
- Manufacturer
- ERIKA DE REYNOSA, S.A. DE C.V.
- Product Code
- FKX
- UDI-DI
- 00840861102068
- PMA / PMN Number
- K222318
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
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 VISUAL INDICATIONS OF DRIED FLUID WITHIN THE CASSETTE COMPARTMENT ON THE PUMP. THERE WERE NO 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. AN INTERNAL VISUAL INSPECTION OF THE RETURNED CYCLER WAS PERFORMED. THERE WERE VISUAL INDICATIONS OF DRIED FLUID ON THE BOTTOM COVER BEHIND THE FRONT PANEL ASSEMBLY. THE CAUSE OF THE OBSERVED DRIED FLUID COULD NOT BE DETERMINED. ALSO FOUND HP FILTERS CLOGGED. THERE WERE NO DISCREPANCIES ENCOUNTERED WITH THE MUSHROOM HEADS. 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 CCPD THERAPY UTILIZING A LIBERTY SELECT CYCLER AND THE SERIOUS ADVERSE EVENTS OF A LOSS OF CONSCIOUSNESS, FALL, LACERATION, AND DEATH, AS THE PATIENT WAS UNDERGOING CCPD THERAPY WHEN THE SERIOUS ADVERSE EVENTS OCCURRED. THE PATIENT¿S PRIMARY CAUSE OF DEATH WAS BLOOD LOSS DUE TO A HEAD WOUND, HOWEVER THE REASON THE PATIENT LOST CONSCIOUSNESS IS UNKNOWN. DESPITE THIS, THE PATIENT¿S PDRN INDICATED THE SERIOUS ADVERSE EVENTS WERE UNRELATED TO ANY FRESENIUS DEVICE(S) AND/OR PRODUCT(S) MALFUNCTION OR DEFICIENCY. THE ESRD POPULATION CONTINUES TO HAVE SIGNIFICANTLY HIGHER MORTALITY, AND FEWER EXPECTED YEARS OF LIFE WHEN COMPARED TO THE GENERAL POPULATION. BASED ON THE INFORMATION AVAILABLE, THE LIBERTY SELECT CYCLER CAN BE DISASSOCIATED FROM THE SERIOUS ADVERSE EVENTS. THERE IS NO ALLEGATION OR OBJECTIVE EVIDENCE INDICATING A FRESENIUS DEVICE(S) AND/OR PRODUCT(S) CAUSED OR CONTRIBUTED TO THE SERIOUS ADVERSE EVENTS. FURTHERMORE, THERE WAS NO REPORT A FRESENIUS PRODUCT(S) AND/OR DEVICE(S) FAILED TO MEET THE USERS¿ EXPECTATIONS AND/OR THE MANUFACTURERS¿ SPECIFICATIONS.
IT WAS REPORTED THAT THIS PATIENT WITH END STAGE RENAL DISEASE (ESRD) CONTINUOUS CYCLIC PERITONEAL DIALYSIS [CC(PD)] UTILIZING A LIBERTY SELECT CYCLER FOR RENAL REPLACEMENT THERAPY (RRT) EXPIRED AFTER FALLING AND HITTING HER HEAD. FOLLOW-UP WITH THE PATIENTS¿ PD REGISTERED NURSE (PDRN) REVEALED THE PATIENT EXPIRED ON (B)(6) 2025 AFTER A FALL AT HOME. THE PATIENT WAS IN BED UNDERGOING CCPD WHEN SHE WOKE HER HUSBAND FOR ASSISTANCE TO THE RESTROOM. AS HER HUSBAND ROUNDED THE BED, HE SAW THE PATIENT APPEAR TO LOSE CONSCIOUSNESS AND FELL FORWARD HITTING HER HEAD ON THE CORNER OF A DRESSER. THE HUSBAND REPORTEDLY CALLED EMERGENCY MEDICAL SERVICES (EMS) AND ATTEMPTED TO STOP THE BLEEDING (PROFUSE) BUT WAS LARGELY UNSUCCESSFUL. DUE TO THE MASSIVE LOSS OF BLOOD, THE PATIENT COULD NOT STABILIZE AND EXPIRED IN TRANSIT TO THE HOSPITAL. THE PDRN STATED THE PATIENT¿S TREATMENT DID NOT HAVE ANY ALARMS NOTED PRIOR TO THE INCIDENT. THE PDRN STATED SHE NEVER RECEIVED THE PATIENT¿S DEATH CERTIFICATE, AND IT AN UNKNOWN WHAT MAY HAVE CAUSED THE PATIENT¿S LOSS OF CONSCIOUSNESS. HOWEVER, THE PDRN REPORTED THE SERIOUS ADVERSE EVENTS WERE NOT CAUSED BY ANY FRESENIUS PRODUCT(S) AND/OR DEVICE(S) DEFICIENCY OR MALFUNCTION. THE PDRN COULD NOT PROVIDE ANY MORE INFORMATION DUE TO THE PATIENT¿S ELECTRONIC MEDICAL RECORD BEING CLOSED.
IT WAS REPORTED THAT THIS PATIENT WITH END STAGE RENAL DISEASE (ESRD) CONTINUOUS CYCLIC PERITONEAL DIALYSIS [CC(PD)] UTILIZING A LIBERTY SELECT CYCLER FOR RENAL REPLACEMENT THERAPY (RRT) EXPIRED AFTER FALLING AND HITTING HER HEAD. FOLLOW-UP WITH THE PATIENTS¿ PD REGISTERED NURSE (PDRN) REVEALED THE PATIENT EXPIRED ON (B)(6) 2025 AFTER A FALL AT HOME. THE PATIENT WAS IN BED UNDERGOING CCPD WHEN SHE WOKE HER HUSBAND FOR ASSISTANCE TO THE RESTROOM. AS HER HUSBAND ROUNDED THE BED, HE SAW THE PATIENT APPEAR TO LOSE CONSCIOUSNESS AND FELL FORWARD HITTING HER HEAD ON THE CORNER OF A DRESSER. THE HUSBAND REPORTEDLY CALLED EMERGENCY MEDICAL SERVICES (EMS) AND ATTEMPTED TO STOP THE BLEEDING (PROFUSE) BUT WAS LARGELY UNSUCCESSFUL. DUE TO THE MASSIVE LOSS OF BLOOD, THE PATIENT COULD NOT STABILIZE AND EXPIRED IN TRANSIT TO THE HOSPITAL. THE PDRN STATED THE PATIENT¿S TREATMENT DID NOT HAVE ANY ALARMS NOTED PRIOR TO THE INCIDENT. THE PDRN STATED SHE NEVER RECEIVED THE PATIENT¿S DEATH CERTIFICATE, AND IT AN UNKNOWN WHAT MAY HAVE CAUSED THE PATIENT¿S LOSS OF CONSCIOUSNESS. HOWEVER, THE PDRN REPORTED THE SERIOUS ADVERSE EVENTS WERE NOT CAUSED BY ANY FRESENIUS PRODUCT(S) AND/OR DEVICE(S) DEFICIENCY OR MALFUNCTION. THE PDRN COULD NOT PROVIDE ANY MORE INFORMATION DUE TO THE PATIENT¿S ELECTRONIC MEDICAL RECORD BEING CLOSED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2374529 | 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 | 72 YR | Female | Death | DELFLEX PD FLUID.| DELFLEX PD FLUID.| LIBERTY CYCLER SET.| LIBERTY CYCLER SET. |