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	050-87216
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Hemorrhage/Blood Loss/Bleeding (1888); Peritonitis (2252)
Date of Event	08/24/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On 4/sep/2026, a patient contact reported to fresenius medical care (fme) technical services this 60-year-old female peritoneal dialysis (pd) patient on continuous cyclic pd (ccpd) therapy utilizing the liberty select cycler was hospitalized with an infection.There was no specific allegation that this event was related to a deficiency or malfunction of any fme device(s) or product(s) in the initial reporting.Upon follow-up with the patient¿s pd registered nurse, it was reported that this patient was hospitalized on (b)(6)2026 following abdominal pain and scantly blood-streaked peritoneal effluent fluid.It was explained that the outpatient clinic is awaiting hospital discharge paperwork and, as a result, diagnostic laboratory findings were not reported.The patient was diagnosed with peritonitis due to a break in aseptic technique during ccpd therapy on the liberty select cycler at home.The patient was prescribed intraperitoneal (ip) ceftazidime and ip gentamycin (dosages and frequencies not reported) to address the infection while hospitalized.The patient was able to undergo continuous ambulatory pd (capd) utilizing hospital provided manual exchanges as capd was the preference of renal replacement therapy in the admitting facility.The patient had an uneventful hospital course, and she was discharged home on (b)(6)2026.It was reported that the patient¿s peritonitis and associated hospitalization were not the result of a deficiency or malfunction of any fresenius product(s) or device(s).The patient recovered from this event and continues ccpd therapy on the same liberty select cycler as before admission.
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 the liberty cycler set and the adverse event of peritonitis, characterized by abdominal pain and scant blood-streaked peritoneal effluent fluid.It is well established that pd patients are at high risk for peritoneum infections.The root cause of this patient¿s peritonitis can be attributed to a break in aseptic technique during pd therapy.A majority of peritonitis infections are the result of contamination to the pd catheter and/or patient connection during pd therapy.Though diagnostic effluent fluid cultures to confirm the source and nature of infection were not provided, a reduction in symptoms in response to antibiotic therapy provided evidence of resolving peritonitis.Based on the available information, there was no allegation or objective evidence of any fresenius product(s) or device(s) deficiency or malfunction caused or contributed to this patient¿s adverse 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: 50863665
• Report Number: 0008030665-2026-02542
• Device Sequence Number: 9425762
• Product Code: FKX
• UDI-Device Identifier: 00840861100750
• UDI-Public: 00840861100750
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Other,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: 050-87216
• Device Lot Number: Unknown
• 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: 09/04/2026
• Initial Report FDA Received Date: 09/23/2026
• 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: 220 LB