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	08/31/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A nurse reported a patient with renal failure (rf) on continuous cyclic peritoneal dialysis \"[cc(pd)]\" utilizing a liberty select cycler and liberty cycler set for renal replacement therapy (rrt) was hospitalized for peritonitis due to user error.Follow-up with the patient¿s primary pd registered nurse (pdrn) verified the patient presented to the emergency room on (b)(6) 2026 with complaints of abdominal pain and cloudy peritoneal effluent fluid.A peritoneal effluent fluid culture and cell count (wbc elevated, result not provided) were collected, and the patient was formally admitted.The patient was diagnosed with peritonitis and was treated with intraperitoneal (ip) vancomycin every 5 days, and ceftazidime daily for 21 days.The patient¿s peritoneal effluent culture result returned positive for methicillin resistant staphylococcus aureus on (b)(6) 2026, and the patient¿s ceftazidime was discontinued.The patient continued to undergo ccpd therapy while hospitalized and is recovering from the serious adverse events.On (b)(6) 2026, the patient was sent to a rehabilitation hospital for strength training and occupational therapy.The patient continues to utilize his personal liberty select cycler at the rehabilitation hospital without any reported issues.The pdrn attributed causality to an unspecified touch contamination event.Per the pdrn, the serious adverse events were not caused by any fme product(s) and/or device(s) deficiency or malfunction.
Additional Manufacturer Narrative
Clinical review: a temporal relationship exists between ccpd therapy utilizing the liberty cycler set and the serious adverse events of peritonitis, characterized by abdominal pain and cloudy peritoneal effluent fluid, which required hospitalization and antibiotic therapy.The pdrn attributed causality to an unspecified touch contamination event and did not involve any fme product(s) and/or device(s) deficiency or malfunction.Esrd patients undergoing pd therapy (manual or cycler based) for rrt are at high risk for infections of the peritoneum.Staphylococcus aureus is commonly found in the mucus membranes and skin of humans and is the most frequent organism associated with peritoneal infections in pd patients.Based on the information available, the patient¿s liberty cycler set can be disassociated from the serious adverse events.There is no allegation or objective evidence indicating a fme device(s) and/or product(s) caused or contributed to the serious adverse events.Furthermore, there was no report that a fme device(s) and/or product(s) failed to meet the users¿ expectations and/or the manufacturers¿ specifications.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: 50885177
• Report Number: 0008030665-2026-02566
• Device Sequence Number: 10755111
• Product Code: FKX
• UDI-Device Identifier: 00840861100750
• UDI-Public: 00840861100750
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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): 09/24/2026

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: 09/10/2026
• 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: Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 154 LB