LIBERTY CYCLER SET, SINGLE CONN./EXT. DL
Report
- Report Number
- 0008030665-2026-00013
- Event Type
- Injury
- Date Received
- January 5, 2026
- Date of Event
- December 8, 2025
- Report Date
- March 31, 2026
- Manufacturer
- ERIKA DE REYNOSA, S.A. DE C.V.
- Product Code
- FKX
- UDI-DI
- 00840861100750
- PMA / PMN Number
- K173718
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- 003
Narratives
CLINICAL REVIEW: A TEMPORAL RELATIONSHIP DOES NOT EXIST BETWEEN CCPD THERAPY WITH THE LIBERTY CYCLER SET AND THE ADVERSE EVENT OF PERITONITIS. IT IS WELL ESTABLISHED THAT PD PATIENTS ARE AT HIGH RISK FOR PERITONEUM INFECTIONS. THE ROOT CAUSE OF THIS PATIENT¿S INFECTION CAN BE ATTRIBUTED TO A CONTAMINATION EVENT TO THE PATIENT¿S PD CATHETER WITH NO INDICATION OF A CONTRIBUTING DEFICIENCY OR MALFUNCTION OF ANY FRESENIUS PRODUCT(S) OR DEVICE(S) AS REPORTED BY A MEDICAL PROFESSIONAL. NONADHERENCE TO ASEPTIC TECHNIQUE INVOLVING THE PATIENT¿S PD CATHETER IS THE LEADING SOURCE OF TRANSMISSION OF PERITONITIS CAUSING PATHOGENS. THIS IS FURTHER EVIDENCE BY THE PRESENCE OF A MICROORGANISM THAT IS PART OF THE NORMAL FLORA OF HUMAN HANDS AND SKIN. THEREFORE, THE LIBERTY SELECT CYCLER WITH THE LIBERTY CYCLER SET CAN BE EXCLUDED AS A POTENTIAL SOURCE OR CONTRIBUTOR TO THIS PATIENT¿S ADVERSE EVENT. BASED ON THE REQUIRED INFORMATION, THERE WAS NO ALLEGATION OR OBJECTIVE EVIDENCE OF ANY FRESENIUS PRODUCT(S) OR DEVICE(S) DEFICIENCY OR MALFUNCTION CAUSED OR CONTRIBUTED TO THIS PATIENT¿S ADVERSE EVENT. THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.
PLANT INVESTIGATION: THE SAMPLE WAS NOT RETURNED TO THE MANUFACTURER AND THE LOT NUMBER WAS NOT PROVIDED. A MANUFACTURING REVIEW WAS PERFORMED ON THE PRODUCTS SHIPPED TO THE PATIENT FOR THE THREE (3) MONTH TIME FRAME WHICH IMMEDIATELY PRECEDED THE EVENT OCCURRENCE DATE. THIS REVIEW INCLUDED THE LOT NUMBERS FOR ALL FRESENIUS LIBERTY CYCLER SETS SHIPPED TO THIS ACCOUNT WITHIN THE SELECTED TIME FRAME. THE ENTIRE SET OF LOTS HAVE BEEN SOLD AND DISTRIBUTED. THERE WERE NO NON-CONFORMANCES OR ABNORMALITIES IDENTIFIED DURING THE MANUFACTURING PROCESS WHICH COULD BE ASSOCIATED WITH THE REPORTED EVENT. AN INVESTIGATION OF THE DEVICE HISTORY RECORDS (DHR) WAS CONDUCTED AND CONFIRMED THAT THE RESULTS OF THE IN-PROGRESS AND FINAL QUALITY CONTROL (QC) TESTING MET ALL REQUIREMENTS. THE PRODUCT LOTS INVOLVED MET ALL SPECIFICATIONS FOR RELEASE. A REVIEW OF THE DHR DID NOT REVEAL A PROBABLE CAUSE FOR THE CUSTOMER COMPLAINT. AS A PHYSICAL EVALUATION COULD NOT BE PERFORMED, A DEFINITIVE CONCLUSION REGARDING THE REPORTED INCIDENT COULD NOT BE REACHED AND A CAUSE COULD NOT BE CONFIRMED.
THE PATIENT CONTACT REPORTED TO FRESENIUS THIS PERITONEAL DIALYSIS (PD) PATIENT EXPERIENCED PERITONITIS. THERE WAS NO SPECIFIC ALLEGATION THAT THIS EVENT WAS RELATED TO A DEFICIENCY OR MALFUNCTION OF ANY FRESENIUS DEVICE(S) OR PRODUCT(S) IN THE INITIAL REPORTING. UPON FOLLOW-UP WITH THE PATIENT¿S PD REGISTERED NURSE (PDRN), IT WAS REPORTED THAT THIS PATIENT PRESENTED TO THE OUTPATIENT CLINIC ON (B)(6) 2025 FOLLOWING AN INCIDENT WHERE THE PATIENT¿S PD CATHETER (NOT A FRESENIUS PRODUCT) HAD MISTAKENLY COME INTO CONTACT WITH THE INSIDE OF THEIR COMMODE AT HOME. THE PATIENT WAS ASYMPTOMATIC WHEN THEY INITIALLY PRESENTED TO THE OUTPATIENT CLINIC BECAUSE THE CONTAMINATION EVENT HAD ONLY OCCURRED TWO DAYS PRIOR. PERITONEAL EFFLUENT FLUID CULTURES AND A WHITE BLOOD CELL (WBC) COUNT OBTAINED IN THE OUTPATIENT CLINIC ON (B)(6) 2025 PRESENTED WITH STAPHYLOCOCCUS CAPITIS IN THE CULTURE AND A WBC COUNT GREATER THAN 1000/MM3 (EXACT COUNT NOT REPORTED). THE PATIENT WAS DIAGNOSED WITH PERITONITIS DUE TO A CONTAMINATION EVENT INVOLVING THEIR PD CATHETER WITH NO TEMPORAL RELATIONSHIP WITH A PD TREATMENT. THE PATIENT WAS NOT HOSPITALIZED FOR THIS EVENT AND PRESCRIBED INTRAPERITONEAL (IP) VANCOMYCIN AT 2000 MG TWICE A WEEK FOR TWO WEEKS AND FOUR DOSES OF IP CEFTAZIDIME DAILY PER CLINIC PROTOCOL. THE PATIENT RECOVERED AS THEY REMAIN ASYMPTOMATIC FOLLOWING COMPLETION OF ANTIBIOTIC THERAPY. IT WAS REPORTED THAT THE PATIENT¿S PERITONITIS WAS NOT THE RESULT OF A DEFICIENCY OR MALFUNCTION OF ANY FRESENIUS PRODUCT(S) OR DEVICE(S). THE PATIENT REMAINS ON CCPD THERAPY ON THE SAME LIBERTY SELECT CYCLER AS BEFORE THIS EVENT.
THE PATIENT CONTACT REPORTED TO FRESENIUS THIS PERITONEAL DIALYSIS (PD) PATIENT EXPERIENCED PERITONITIS. THERE WAS NO SPECIFIC ALLEGATION THAT THIS EVENT WAS RELATED TO A DEFICIENCY OR MALFUNCTION OF ANY FRESENIUS DEVICE(S) OR PRODUCT(S) IN THE INITIAL REPORTING. UPON FOLLOW-UP WITH THE PATIENT¿S PD REGISTERED NURSE (PDRN), IT WAS REPORTED THAT THIS PATIENT PRESENTED TO THE OUTPATIENT CLINIC ON (B)(6) 2025 FOLLOWING AN INCIDENT WHERE THE PATIENT¿S PD CATHETER (NOT A FRESENIUS PRODUCT) HAD MISTAKENLY COME INTO CONTACT WITH THE INSIDE OF THEIR COMMODE AT HOME. THE PATIENT WAS ASYMPTOMATIC WHEN THEY INITIALLY PRESENTED TO THE OUTPATIENT CLINIC BECAUSE THE CONTAMINATION EVENT HAD ONLY OCCURRED TWO DAYS PRIOR. PERITONEAL EFFLUENT FLUID CULTURES AND A WHITE BLOOD CELL (WBC) COUNT OBTAINED IN THE OUTPATIENT CLINIC ON (B)(6) 2025 PRESENTED WITH STAPHYLOCOCCUS CAPITIS IN THE CULTURE AND A WBC COUNT GREATER THAN 1000/MM3 (EXACT COUNT NOT REPORTED). THE PATIENT WAS DIAGNOSED WITH PERITONITIS DUE TO A CONTAMINATION EVENT INVOLVING THEIR PD CATHETER WITH NO TEMPORAL RELATIONSHIP WITH A PD TREATMENT. THE PATIENT WAS NOT HOSPITALIZED FOR THIS EVENT AND PRESCRIBED INTRAPERITONEAL (IP) VANCOMYCIN AT 2000 MG TWICE A WEEK FOR TWO WEEKS AND FOUR DOSES OF IP CEFTAZIDIME DAILY PER CLINIC PROTOCOL. THE PATIENT RECOVERED AS THEY REMAIN ASYMPTOMATIC FOLLOWING COMPLETION OF ANTIBIOTIC THERAPY. IT WAS REPORTED THAT THE PATIENT¿S PERITONITIS WAS NOT THE RESULT OF A DEFICIENCY OR MALFUNCTION OF ANY FRESENIUS PRODUCT(S) OR DEVICE(S). THE PATIENT REMAINS ON CCPD THERAPY ON THE SAME LIBERTY SELECT CYCLER AS BEFORE THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 27921 | LIBERTY CYCLER SET, SINGLE CONN./EXT. DL | SYSTEM, PERITONEAL, AUTOMATIC DELIVERY | FKX | ERIKA DE REYNOSA, S.A. DE C.V. | 00840861100750 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Female | Required Intervention | DELFLEX PD FLUID| DELFLEX PD FLUID| LIBERTY SELECT CYCLER| LIBERTY SELECT CYCLER |