MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. LIBERTY SELECT CYCLER ASSY(NON-VALUATED); System, Peritoneal, Automatic Delivery

Catalog Number	RTLR180343
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	09/14/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A peritoneal dialysis (pd) patient contact reported to fresenius medical care customer support that the patient went into the hospital yesterday.The patient did a manual exchange over the weekend and her fluid was cloudy.The patient was advised that she has an infection but test results have not come back to determine if her infection is peritonitis.Follow-up with the patient¿s pd registered nurse (pdrn) confirmed 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 unavailable) 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 negative for growth; however, the patient¿s antibiotic regimen will continue.The patient continued to undergo ccpd while hospitalized and was discharged home in stable condition on (b)(6) 2026.The patient is recovering and continues to utilize the same liberty select cycler following discharge without any reported issues.The pdrn stated the cause of the peritonitis is unknown; however, the pdrn was confident it was not caused by any fresenius product(s) and/or device(s) deficiency or malfunction.
Additional Manufacturer Narrative
Clinical investigation: a temporal relationship exists between ccpd therapy utilizing the liberty select cycler, 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 reported that the etiology of the serious adverse events is unknown; therefore, causality could not be firmly established.However, the pdrn reported the serious adverse events were not caused by any fresenius 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.Additionally, in up to 20% of all peritonitis cases no organism is identified, and diagnosis can only be made by performing a cytological examination of the pd fluid and physical symptoms.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 the patient¿s 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 manufacturer specifications, as evidenced by the devices continued use.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

• Brand Name: LIBERTY SELECT CYCLER ASSY(NON-VALUATED)
• 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: 50869106
• Report Number: 0008030665-2026-02544
• Device Sequence Number: 18470110
• Product Code: FKX
• UDI-Device Identifier: 00840861102068
• UDI-Public: 00840861102068
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K222318
• 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
• Report Date (Section B): 09/23/2026

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: RTLR180343
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2014
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: Delflex PD Fluid.; Liberty Cycler Set.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 187 LB