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)
Date of Event	09/05/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by a peritoneal dialysis (pd) nurse that this patient on pd was hospitalized for a pd related issue.There were no reported allegations that the event was caused by fresenius products.In additional follow-up call, another pd nurse familiar with the patient confirmed that on (b)(6) 2026 this patient was hospitalized with symptoms of abdominal pain.Per the nurse, the patient had a pd culture obtained (in the hospital) which had growth of candida parapsilosis.The nurse indicated that the patient was initiated on antibiotic therapy in the hospital utilizing intravenous (iv) cefepime, cefazolin (dosing not provided) and antifungal therapy with iv micafungin (dose not provided).Additionally, the nurse stated that the patient underwent removal of the pd catheter (not a fresenius product) and was switched to hemodialysis for renal replacement needs.The patient remained in the hospital at the time follow-up was performed.The patient¿s nurse confirmed that the patient did not have any fluid leaks or issues with fresenius products in relation to the peritonitis event.The nurse stated that the peritonitis event was attributed to patient breach in aseptic technique.
Additional Manufacturer Narrative
Clinical review: a temporal relationship exists between the pd therapy with the liberty cycler set and the patient¿s peritonitis event.However, currently there is no objective evidence that a liberty cycler set malfunction or product deficiency caused this event.Peritonitis is a well-documented complication in pd patients.Based on the available information, the peritonitis event can be attributed to patient breach in aseptic technique.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: 50882301
• Report Number: 0008030665-2026-02557
• Device Sequence Number: 13450430
• Product Code: FKX
• UDI-Device Identifier: 00840861100750
• UDI-Public: 00840861100750
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• 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?: Yes
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2026
• Initial Report FDA Received Date: 09/24/2026
• 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: Male