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)
Date of Event	08/10/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this peritoneal dialysis (pd) patient was hospitalized due to peritonitis.Additional information was provided through follow-up with the patient¿s peritoneal dialysis registered nurse (pdrn) and an email response provided by that pdrn.On (b)(6) 2026, the patient was experiencing severe abdominal pain.The pain began on (b)(6) 2026.The patient called 911 and was transported via ambulance to the emergency room (er).The patient is in a wheelchair and cannot drive himself to the hospital.The patient was admitted to the hospital with a diagnosis of peritonitis.Pd cultures were obtained on (b)(6) 2026.The patient was initiated on antibiotic therapy with intraperitoneal (ip) fluconazole 200mg daily and vancomycin 1750mg every 5th day to be completed on (b)(6) 2026.The patient¿s cultures were positive for methicillin-resistant staphylococcus aureus (mrsa).The patient was discharged on (b)(6) 2026.The patient received a dose of vancomycin on (b)(6) 2026 with the next dose on (b)(6) 2026.The suspected cause of the peritonitis event is a touch contamination event during an initial hospitalization for gallstones in which the patient was discharged on (b)(6) 2026.The patient returned to the hospital on (b)(6) 2026 to have the pd catheter (not a fresenius medical care product) removed and to transition to hemodialysis (hd).
Additional Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.  clinical review: there is a temporal relationship between peritoneal dialysis utilizing the liberty cycler set and the patient event of mrsa peritonitis.However, there is no causal relationship between the use of the liberty cycler set and the peritonitis event.Additionally, there is no allegation of a cycler set defect reported for this event.The patient had an initial hospitalization for gallstones with a discharge date a few days prior to the peritonitis diagnosis.The abdominal pain began on the date of discharge.The suspected cause of the patient¿s peritonitis was a touch contamination event during that hospitalization.Generally, mrsa peritonitis is due to accidental contamination with skin bacteria during exchanges.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.

• 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: 50544834
• Report Number: 0008030665-2026-02360
• Device Sequence Number: 10376680
• Product Code: FKX
• UDI-Device Identifier: 00840861102716
• UDI-Public: 00840861102716
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2026

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
• Device Lot Number: Unknown
• 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: 08/20/2026
• Supplement Date Received by Manufacturer: 09/25/2026
• Initial Report FDA Received Date: 09/01/2026
• Supplement Report FDA Received Date: 09/30/2026
• 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