LIBERTY SELECT CYCLER ASSY(NON-VALUATED)
Report
- Report Number
- 0008030665-2026-00414
- Event Type
- Death
- Date Received
- March 2, 2026
- Date of Event
- January 18, 2026
- Report Date
- March 16, 2026
- 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
- ID, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
ADDITIONAL INFORMATION PROVIDED IN D9 AND H3. PLANT INVESTIGATION: A VISUAL INSPECTION OF THE RETURNED CYCLER EXTERIOR SHOWED SIGNS OF TOUCH SCREEN BEING MISALIGNED (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. SYSTEM AIR LEAK TEST PASSED. VALVE ACTUATION TEST 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. AN INTERNAL VISUAL INSPECTION OF THE RETURNED CYCLER WAS PERFORMED. THERE WERE VISUAL INDICATIONS OF DRIED FLUID UNDER THE PUMP ASSEMBLY ON THE BOTTOM COVER. THE CAUSE OF THE OBSERVED DRIED FLUID COULD NOT BE DETERMINED. 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 PD THERAPY WITH THE LIBERTY SELECT CYCLER AND THE PATIENT¿S DEATH FROM MYOCARDIAL INFARCTION. THE FRESENIUS CYCLER IS PENDING RETURN TO MANUFACTURER AT THE TIME THIS CLINICAL INVESTIGATION WAS PERFORMED. HOWEVER, CURRENTLY THERE IS NO OBJECTIVE EVIDENCE THAT A LIBERTY SELECT CYCLER MALFUNCTION OR PRODUCT DEFICIENCY CAUSED THIS EVENT. PATIENTS WITH END STAGE RENAL DISEASE (ESRD) CARRY A HIGHER RISK OF MORTALITY COMPARED TO THE GENERAL POPULATION. FURTHERMORE, THE PATIENT¿S PD NURSE REPORTED THAT THE PATIENT HAD PRE-EXISTING CARDIAC DISEASE WITH KNOWN ARTERIAL BLOCKAGES. ADDITIONALLY, IT WAS STATED THE PATIENT NEEDED CABG SURGERY BUT THAT THE PATIENT WAS NOT MEDICAL STABLE TO PROCEED WITH THIS INTERVENTION. BASED ON THE INFORMATION PROVIDED, THE PATIENT¿S DEATH IS MOST LIKELY DUE TO PATIENT PRE-EXISTING CARDIAC COMORBID CONDITIONS.
IT WAS REPORTED BY A PERITONEAL DIALYSIS (PD) NURSE THAT THIS PATIENT EXPIRED WHILE DIALYZING WITH THE FRESENIUS CYCLER. IN ADDITIONAL FOLLOW-UP, THE PD NURSE STATED THIS PATIENT HAD PRE-EXISTING EXTENSIVE CARDIAC DISEASE WITH KNOWN CORONARY ARTERY BLOCKAGES. THE NURSE STATED IT WAS KNOWN THAT THE PATIENT NEEDED A CORONARY ARTERY BYPASS GRAFT (CABG). HOWEVER, THE NURSE INDICATED THAT THE PATIENT WAS NOT CARDIAC STABLE ENOUGH TO PROCEED WITH THAT SURGERY. THE NURSE CONFIRMED THAT ON (B)(6) 2026 THE PATIENT COLLAPSED WHILE IN FILL 1 OF PD TREATMENT WITH THE FRESENIUS CYCLER. THERE WERE NO REPORTED ALLEGATIONS OF ANY ISSUES WITH THE FRESENIUS CYCLER IN RELATION TO THIS EVENT. THE NURSE STATED THAT EMERGENCY MEDICAL SERVICES (EMS) WAS NOTIFIED AND UPON ARRIVAL AT THE PATIENT¿S HOME THE PATIENT WAS PRONOUNCED DECEASED ON ARRIVAL (DOA). THE NURSE STATED THAT THE PATIENT WAS NOT BROUGHT TO THE HOSPITAL. THE FRESENIUS CYCLER IS PENDING RETURN TO MANUFACTURER AND THE NURSE STATED THE DEATH WAS REPORTED TO OBTAIN A RETURN GOOD AUTHORIZATION (RGA). PER THE NURSE, THE CAUSE OF DEATH WAS A SUDDEN AND MASSIVE HEART ATTACK. THE NURSE INDICATED THAT THE FRESENIUS CYCLER IS NOT SUSPECTED IN ANYWAY TO HAVE CAUSED THE PATIENT¿S DEATH. THE PD NURSE STATED THE PATIENT WAS COMPLETING PD TREATMENTS ON THE CYCLER PRIOR TO THIS EVENT WITHOUT ANY ISSUES. THE NURSE ATTRIBUTED THE PATIENT¿S MASSIVE HEART ATTACK WITH SUDDEN DEATH TO PRE-EXISTING CARDIAC DISEASE WITH KNOWN ARTERIAL BLOCKAGES.
IT WAS REPORTED BY A PERITONEAL DIALYSIS (PD) NURSE THAT THIS PATIENT EXPIRED WHILE DIALYZING WITH THE FRESENIUS CYCLER. IN ADDITIONAL FOLLOW-UP, THE PD NURSE STATED THIS PATIENT HAD PRE-EXISTING EXTENSIVE CARDIAC DISEASE WITH KNOWN CORONARY ARTERY BLOCKAGES. THE NURSE STATED IT WAS KNOWN THAT THE PATIENT NEEDED A CORONARY ARTERY BYPASS GRAFT (CABG). HOWEVER, THE NURSE INDICATED THAT THE PATIENT WAS NOT CARDIAC STABLE ENOUGH TO PROCEED WITH THAT SURGERY. THE NURSE CONFIRMED THAT ON (B)(6) 2026 THE PATIENT COLLAPSED WHILE IN FILL 1 OF PD TREATMENT WITH THE FRESENIUS CYCLER. THERE WERE NO REPORTED ALLEGATIONS OF ANY ISSUES WITH THE FRESENIUS CYCLER IN RELATION TO THIS EVENT. THE NURSE STATED THAT EMERGENCY MEDICAL SERVICES (EMS) WAS NOTIFIED AND UPON ARRIVAL AT THE PATIENT¿S HOME THE PATIENT WAS PRONOUNCED DECEASED ON ARRIVAL (DOA). THE NURSE STATED THAT THE PATIENT WAS NOT BROUGHT TO THE HOSPITAL. THE FRESENIUS CYCLER IS PENDING RETURN TO MANUFACTURER AND THE NURSE STATED THE DEATH WAS REPORTED TO OBTAIN A RETURN GOOD AUTHORIZATION (RGA). PER THE NURSE, THE CAUSE OF DEATH WAS A SUDDEN AND MASSIVE HEART ATTACK. THE NURSE INDICATED THAT THE FRESENIUS CYCLER IS NOT SUSPECTED IN ANYWAY TO HAVE CAUSED THE PATIENT¿S DEATH. THE PD NURSE STATED THE PATIENT WAS COMPLETING PD TREATMENTS ON THE CYCLER PRIOR TO THIS EVENT WITHOUT ANY ISSUES. THE NURSE ATTRIBUTED THE PATIENT¿S MASSIVE HEART ATTACK WITH SUDDEN DEATH TO PRE-EXISTING CARDIAC DISEASE WITH KNOWN ARTERIAL BLOCKAGES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 621395 | 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 |