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	050-87216A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Vomiting (2144); Peritonitis (2252)
Date of Event	08/07/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A call was placed to customer support requesting assistance with cancelling this patient¿s peritoneal dialysis (pd) treatment.There were no reported issues with the fresenius cycler.However, it was stated the patient was going to the hospital due to not feeling well.In additional follow-up, the patient¿s pd nurse confirmed that on (b)(6) 2026 the patient was hospitalized with symptoms of vomiting.The nurse stated the patient had a pd culture obtained (in the hospital) which had growth of vancomycin resistant enterococcus (vre).Per the nurse, the patient was diagnosed with peritonitis and was initiated on antibiotic therapy utilizing intravenous (iv) daptomycin (dosing not provided).The patient remained in the hospital at the time follow-up was performed.The nurse could not provide the exact cause for peritonitis.However, it was confirmed the patient did not have fluid leaks or any issues/malfunctions with fresenius products in relation to the event.
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 the pd therapy with the liberty select cycler/liberty cycler set and the patient¿s peritonitis event.Based on the available information, the exact cause for peritonitis cannot be determined.However, there is no allegation nor any objective evidence that a liberty select cycler/liberty cycler set malfunction or product deficiency caused the peritonitis event.Peritonitis is a well-documented complication in patients undergoing pd therapy that is most associated with a patient breach in aseptic technique during the pd exchange.

• 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: 50310981
• Report Number: 0008030665-2026-02232
• Device Sequence Number: 18335530
• Product Code: FKX
• UDI-Device Identifier: 00840861102716
• UDI-Public: 00840861102716
• Combination Product (Y/N): N
• 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
• 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: 050-87216A
• 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: 08/07/2026
• 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: Required Intervention; Hospitalization
• Patient Sex: Male