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); Vomiting (2144); Peritonitis (2252)
Date of Event	09/05/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A nurse reported a peritoneal dialysis (pd) patient was hospitalized due to peritonitis.Additional information was obtained through follow-up with the patient¿s peritoneal dialysis registered nurse (pdrn).The patient had been seen in the pd clinic on (b)(6) 2026 due to drain issues.Patency was checked without issues and the patient had clear effluent at that time.The patient went to the hospital on (b)(6) 2026 due to abdominal pain and vomiting.The patient was admitted to the hospital.On (b)(6) 2026, pd cultures were drawn.The patient was diagnosed with peritonitis.The patient was initiated on antibiotic therapy with cefepime in normal saline (ns) 500mg/50ml intravenous piggy-back (ivpb) every 12 hours and vancomycin 1000mg in sodium chloride 0.9% ns 250ml ivpb (frequency and duration unknown).The patient¿s white blood cell (wbc) count was >50,000.The pd cultures were positive for gram positive cocci with moderate growth, staphylococcus epidermidis.The patient remains hospitalized.The patient continues ccpd therapy in the hospital.The suspected cause of the peritonitis episode is lack of aseptic technique.
Additional Manufacturer Narrative
Clinical review: there is a temporal relationship between pd therapy utilizing the liberty cycler set and the patient event of peritonitis.However, there is no documentation in the complaint file to show a causal relationship between the adverse event and use of the liberty cycler set.Additionally, there is no allegation of a cycler set defect reported for this peritonitis event.The cause of the patient¿s peritonitis is lack of aseptic technique.The pd effluent culture result of staphylococcus epidermidis supports that determination as staph epi is a predominant normal flora of the human skin and the most frequently identified cause of pd-associated peritonitis.Based on the available information and no allegation of a defect, the liberty cycler set can be excluded as causing or contributing to the patient¿s peritonitis.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: 50910598
• Report Number: 0008030665-2026-02583
• Device Sequence Number: 5777306
• Product Code: FKX
• UDI-Device Identifier: 00840861102716
• UDI-Public: 00840861102716
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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,Followup
• Report Date (Section B): 10/01/2026

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: 09/16/2026
• Supplement Date Received by Manufacturer: 09/28/2026
• Initial Report FDA Received Date: 09/28/2026
• Supplement Report FDA Received Date: 10/01/2026
• 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: Female
• Patient Weight: 114 LB