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 Code	Peritonitis (2252)
Date of Event	07/15/2026
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 hospitalized on (b)(6) 2026 through (b)(6) 2026 due to peritonitis.Subsequent attempts to obtain additional clinical information (e.G., hospital records, discharge summary, medication records) were unsuccessful.
Additional Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.  clinical review: it is unknown if a temporal relationship exists between ccpd therapy utilizing the liberty select cycler, liberty cycler set and the serious adverse event of peritonitis, which required hospitalization and pd catheter (not a fresenius product) removal.The etiology of the serious adverse events is unknown; therefore, causality could not be established.Esrd patients undergoing pd therapy (manual or cycler based) for rrt are at high risk for infections of the peritoneum.It should be noted that a lack of clinical follow-up precluded a more comprehensive investigation.Based on the information available, the liberty select cycler and liberty cycler set cannot be disassociated from the serious adverse events.There is no allegation or objective evidence indicating the patient¿s fresenius device(s) and/or product(s) caused or contributed to the serious adverse events, nor was there any report that a fresenius device(s) and/or product(s) failed to meet the users¿ expectations and/or manufacturer specifications.However, based on the lack of causality, timeline, medical history and clinical follow-up, this clinical investigation cannot exclude the liberty select cycler or liberty cycler set from having a possible causal or contributory role in the serious adverse events.

• 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: 50297744
• Report Number: 0008030665-2026-02227
• Device Sequence Number: 10698323
• Product Code: FKX
• UDI-Device Identifier: 00840861100736
• UDI-Public: 00840861100736
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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
• Report Date (Section B): 08/18/2026

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?: Yes
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2026
• Initial Report FDA Received Date: 08/18/2026
• 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