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	Abdominal Pain (1685); Peritonitis (2252); Peritoneal effluent abnormal (4904)
Date of Event	07/20/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this patient on peritoneal dialysis (pd) was hospitalized with peritonitis.There were no reported allegations that the event was caused by fresenius product.In additional follow-up, the patient¿s pd nurse confirmed that the patient was hospitalized on (b)(6)2026 with symptoms of abdominal pain and cloudy pd effluent.The nurse reported that the patient had a pd culture obtained in the hospital.However, the nurse indicated that the pd culture results were not available.The nurse stated the patient was diagnosed with peritonitis and is receiving antibiotic therapy while hospitalized (details are unknown).Additionally, the pd nurse reported that the patient underwent removal of the pd catheter (not a fresenius product) and was transitioned to hemodialysis modality for renal replacement needs.The patient remained in the hospital when follow-up was performed.The nurse confirmed the patient did not have fluid leaks or any issues/malfunctions with fresenius products in relation to the event.The nurse stated that the peritonitis was due to a patient breach in aseptic technique.
Additional Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.  clinical review: a temporal relationship exists between the pd therapy with the liberty cycler set and the patient¿s peritonitis event.Currently, there is no allegation nor is there any objective evidence that a liberty cycler set malfunction or product deficiency caused this event.Peritonitis is a well-documented complication in patients undergoing pd therapy.Based on the available information, the event of peritonitis is associated with 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: 50130229
• Report Number: 0008030665-2026-02080
• Device Sequence Number: 13390291
• Product Code: FKX
• UDI-Device Identifier: 00840861102716
• UDI-Public: 00840861102716
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 08/04/2026

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?: No
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2026
• Initial Report FDA Received Date: 08/04/2026
• 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