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); Peritonitis (2252)
Date of Event	07/16/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On 21/jul/2026, fmcrtg became aware this 66-year-old male patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis "[cc(pd)]" utilizing a liberty select cycler and liberty cycler set for renal replacement therapy (rrt) was hospitalized due to peritonitis.Follow-up with the patient¿s pd registered nurse (pdrn) revealed the patient presented to the emergency room (er) on (b)(6) 2026 with complaints of dull abdominal pain (rating 6/10).A peritoneal effluent fluid culture and cell count (wbc = >100 u/l, polymorphs = 50%) were collected, and the patient was formally admitted.The patient was diagnosed with peritonitis and was initially treated with empiric intravenous (iv) vancomycin and cefepime (dosages, frequencies, durations not provided), which were transitioned to intraperitoneal (ip) vancomycin, cefepime, and nystatin (dosages, frequencies, durations not provided).However, the patient¿s peritoneal effluent culture result returned positive for staphylococcus epidermidis on (b)(6) 2026, and the patient¿s vancomycin, cefepime, and nystatin were discontinued and replaced with ip cefazolin for 14 days (dose, frequency not provided).The patient continued to undergo ccpd therapy while hospitalized (baxter cycler) and was discharged home on (b)(6) 2026.Following discharge, the patient resumed utilizing the same liberty select cycler 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 fresenius product(s) and/or device(s) deficiency or malfunction.The patient is expected at the outpatient home dialysis clinic on (b)(6) 2026 for a post-hospitalization assessment, and follow-up cultures are scheduled to be drawn on (b)(6) 2026.
Additional Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.Clinical investigation: a temporal relationship exists between ccpd therapy utilizing a liberty cycler set and the serious adverse event of peritonitis, characterized by abdominal pain, which warranted hospitalization and antibiotic therapy.The pdrn attributed causality to an unspecified touch contamination event.Esrd patients undergoing pd therapy (manual or cycler based) are at high risk for infections of the peritoneum.Staphylococcus epidermidis is found in the mucus membranes, axillae, and skin of humans, and transmission of the bacteria to the peritoneum frequently occurs during a touch contamination event.Per the pdrn, the serious adverse events were unrelated to any fresenius product(s) and/or device(s) deficiency or malfunction.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 fresenius device(s) and/or product(s) caused or contributed to the serious adverse events.Furthermore, there is no report a fresenius device(s) and/or product(s) failed to meet the users¿ expectations and/or the manufacturers¿ specifications, as evidenced by the devices¿ continued use.

• 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: 50085069
• Report Number: 0008030665-2026-02045
• Device Sequence Number: 13282768
• Product Code: FKX
• UDI-Device Identifier: 00840861100736
• UDI-Public: 00840861100736
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 09/28/2026

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
• 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: 07/21/2026
• Supplement Date Received by Manufacturer: 09/18/2026
• Initial Report FDA Received Date: 07/30/2026
• Supplement Report FDA Received Date: 09/28/2026
• 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