MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. LIBERTY CYCLER SET, SINGLE CONN./EXT. DL; System, Peritoneal, Automatic Delivery

Catalog Number	050-87216
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Peritonitis (2252); Peritoneal effluent abnormal (4904)
Date of Event	09/12/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A peritoneal dialysis (pd) patient reported to fresenius medical care customer support that the patient is in hospital.The patient contact advised the patient has peritonitis.Upon follow-up with the patient¿s pd registered nurse, it was reported that this patient was hospitalized on (b)(6) 2026 following abdominal pain and cloudy peritoneal effluent fluid.Peritoneal effluent fluid cultures and a white blood cell (wbc) count obtained and tested in the hospital on (b)(6) 2026 presented with staphylococcus epidermidis in the culture and an elevated wbc count (exact count not reported).The patient was diagnosed with peritonitis due to touch contamination during ccpd therapy on the liberty select cycler at home.The patient was prescribed vancomycin, cefepime and gentamycin (routes, dosages and frequencies not reported) to address the infection while hospitalized.The patient¿s pd catheter (not an fme product) was removed due to the severity of infection as she was transitioned to hemodialysis (hd) for renal replacement therapy on a hospital provided hd device (unknown brand and model) for the duration of the admission.The patient had an uneventful hospital course, and she was discharged home on (b)(6) 2026.It was reported that the patient¿s peritonitis and associated hospitalization were not the result of a deficiency or malfunction of any fme product(s) or device(s).The patient is currently training for home hd and will not be returning to ccpd therapy.
Additional Manufacturer Narrative
Clinical investigation: a temporal relationship exists between ccpd therapy utilizing the liberty cycler set and the adverse event of peritonitis, characterized by abdominal pain and cloudy peritoneal effluent fluid.It is well established that pd patients are at high risk for peritoneum infections.The root cause of this patient¿s peritonitis can be attributed to touch contamination during pd therapy with no indication of a causal or contributing malfunction or deficiency of any fme product(s) or device(s) as reported by a medical professional.Nonadherence to asepsis during pd therapy through touch contamination is the leading source of transmission of peritonitis causing pathogens.This is further evidenced by the presence of a microorganism that is part of the normal flora of human hands and skin.Therefore, the liberty cycler set can be excluded as a source or contributor to this patient¿s adverse event.Based on the available 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.

• Brand Name: LIBERTY CYCLER SET, SINGLE CONN./EXT. DL
• Common Device Name: System, Peritoneal, Automatic Delivery
• Manufacturer (Section D): ERIKA DE REYNOSA, S.A. DE C.V.; mike allen #1331; parque industrial reynosa; reynosa 88780 ; MX 88780
• Manufacturer (Section G): ERIKA DE REYNOSA, S.A. DE C.V.; director, quality systems; 900 w zaragosa drive suite d; pharr TX 78577
• Manufacturer Contact: jessica trujillo ; 920 winter st; waltham, MA 02451 ; +1(617)417-5172
• MDR Report Key: 50870603
• Report Number: 0008030665-2026-02551
• Device Sequence Number: 21177110
• Product Code: FKX
• UDI-Device Identifier: 00840861100750
• UDI-Public: 00840861100750
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K173718
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/23/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 050-87216
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: Delflex PD Fluid.; Liberty Select Cycler.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 158 LB