MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. LIBERTY CYCLER SET, DUAL PATIENT CONNECT; System, Peritoneal, Automatic Delivery

Catalog Number	050-87212
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Nausea (1970); Vomiting (2144); Peritonitis (2252)
Date of Event	07/21/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A nurse reported that this peritoneal dialysis (pd) patient was bleeding (unknown source) and hospitalized.The patient was diagnosed with peritonitis.Additional information was obtained through follow-up with the patient¿s peritoneal dialysis registered nurse (pdrn).The patient was admitted to the hospital on (b)(6) 2026 with complaints of nausea, vomiting, abdominal soreness and a non-functioning pd catheter (not a fresenius product).A pd culture was drawn on (b)(6) 2026.Prior to the patient going to the hospital, they were administered vancomycin 1 gm intravenous (iv) infusion once and fortaz 1 gm iv infusion once.No additional information pertaining to antibiotic therapy was provided.The patient¿s cultures resulted positive for serratia liquefaciens.The white blood cell (wbc) count was 660 with 71% polymorphonuclear (pmn) cells.The patient was diagnosed with peritonitis on (b)(6) 2026.The patient¿s diagnoses were peritonitis and non-functioning pd catheter.The patient was switched to back-up home hemodialysis (hhd) for 3 weeks.The patient will resume pd if the catheter is functioning.The cause of the peritonitis event is unknown but is suspected to be a breach in aseptic technique.The source of the patient¿s bleed was not determined, however; the physician suspected it was due to inflammation caused by the peritonitis infection as the blood was coming from the peritoneal cavity.The bleed was resolved.It is unknown if the patient received any medical intervention for the reported bleed.The patient was not diagnosed with any type of gastrointestinal (gi) involvement.
Additional Manufacturer Narrative
Clinical review: there is a temporal relationship between peritoneal dialysis utilizing the liberty cycler set and the patient event of peritonitis with hospitalization and temporary transition to hemodialysis.However, there is no documentation of a causal relationship between the adverse event and the use of the liberty cycler set.Additionally, there is no allegation of a cycler set defect reported for this event.The suspected cause of the peritonitis event is a breach in aseptic technique which is supported by the culture results of serratia liquefaciens, an organism which colonizes hands and the respiratory, gastrointestinal, and urinary tracts.The reported bleeding was thought to be from the inflammation caused by peritonitis.The bleed resolved.Based on the available information and no allegation or evidence of a defect, the liberty cycler set can be excluded as the cause of the patient¿s peritonitis event.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

• Brand Name: LIBERTY CYCLER SET, DUAL PATIENT CONNECT
• 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: 50203723
• Report Number: 0008030665-2026-02160
• Device Sequence Number: 20214164
• Product Code: FKX
• UDI-Device Identifier: 00840861100736
• UDI-Public: 00840861100736
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 08/10/2026

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: 050-87212
• 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: 07/27/2026
• Initial Report FDA Received Date: 08/11/2026
• 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
• Patient Weight: 171 LB