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	050-87216A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Muscle Weakness/Atrophy (1967); Peritonitis (2252)
Date of Event	09/04/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2026, it was reported that this patient on peritoneal dialysis (pd) therapy was hospitalized for peritonitis.There were no reported allegations that the event was caused by fresenius products.In additional follow-up call, the patient¿s pd nurse confirmed that on (b)(6) 2026 this patient was hospitalized with symptoms of weakness.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 initiated on antifungal therapy intravenously (iv); details are unknown.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 in the setting of the patient having failure to thrive.
Additional Manufacturer Narrative
Plant investigation: the plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.Clinical investigation: 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.

• 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: 50791645
• Report Number: 0008030665-2026-02485
• Device Sequence Number: 15806492
• Product Code: FKX
• UDI-Device Identifier: 00840861102716
• UDI-Public: 00840861102716
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2026

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: 050-87216A
• 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
• Supplement Date Received by Manufacturer: 09/25/2026
• Initial Report FDA Received Date: 09/16/2026
• Supplement Report FDA Received Date: 09/25/2026
• 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: Liberty Select Cycler.; PD Solution.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female