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); Peritoneal effluent abnormal (4904)
Date of Event	07/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this 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 diagnosed with an infection on (b)(6) 2026 and was started on antibiotics.During follow-up, the patient¿s pd registered nurse (pdrn) reported the patient presented to the outpatient home dialysis clinic on (b)(6) 2026 with complaints of abdominal pain.A peritoneal effluent fluid culture and cell count (cloudy, wbc = 1874 u/l, polymorphs = 83%) were collected, and the patient was diagnosed with peritonitis.The patient was initially treated with intraperitoneal (ip) vancomycin 1500 mg every 4 days (based on vancomycin trough level), and ceftazidime 1500 mg daily for 14 days.However, the patient¿s peritoneal effluent culture result returned positive for enterococcus faecalis on (b)(6) 2026, and the patient¿s ceftazidime was discontinued and replaced with oral ampicillin 500 mg for 21 days and the vancomycin was increased to every 3 days.The patient has recovered from the serious adverse events and has continued to undergo ccpd therapy utilizing the same liberty select cycler without any reported issues.The pdrn stated the cause of the peritonitis is unknown; however, it was unrelated to any fresenius product(s) and/or device(s) deficiency or malfunction.
Additional Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.Clinical review: a temporal relationship exists between ccpd therapy utilizing the liberty select cycler, liberty cycler set and the serious adverse event of peritonitis, characterized by abdominal pain and cloudy peritoneal effluent fluid, which required antibiotic therapy.The pdrn stated the etiology of the serious adverse events is unknown; therefore, causality could not be firmly established.However, the serious adverse events were unrelated to any fresenius device(s) and/or product(s) malfunction or deficiency.Esrd patients undergoing pd therapy (manual or cycler based) for rrt are at high risk for infections of the peritoneum.Enterococcus faecalis is a normal inhabitant of the human gastrointestinal tract, and peritoneal enterococcal infections are usually the result of a gi contaminant.Based on the information available, the liberty select cycler and 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 was 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: 25891509
• Report Number: 0008030665-2026-01938
• Device Sequence Number: 18596627
• Product Code: FKX
• UDI-Device Identifier: 00840861100736
• UDI-Public: 00840861100736
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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: Consumer,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2026

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?: No
• Was the Report Sent to FDA?: No
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2026
• Supplement Date Received by Manufacturer: 09/15/2026
• Initial Report FDA Received Date: 07/21/2026
• Supplement Report FDA Received Date: 09/17/2026
• 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
• Patient Age: 61 YR
• Patient Sex: Male