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)
Date of Event	05/27/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.Clinical review: there is a temporal relationship between peritoneal dialysis and the use of the liberty cycler set and the patient event of peritonitis with hospitalization.However, there is no documentation in the complaint file to show a causal relationship between use of the cycler set and the peritonitis event.Additionally, there is no allegation of a cycler set defect reported for this event.The cause of the peritonitis event was attributed to touch contamination.This is supported by the culture results of staphylococcus warneri, a component of the normal skin microbiome as a common saprophyte.Based on available information and no allegation of a defect, the liberty cycler set can be excluded as the cause of the patient¿s reported peritonitis event.
Event or Problem Description
It was reported that this peritoneal dialysis (pd) patient reported being hospitalized due to peritonitis.The patient could not remember the admission date but provided (b)(4) 2026 as the discharge date.Additional information was obtained through follow-up with the patient¿s peritoneal dialysis registered nurse (pdrn).The patient went to the hospital on (b)(6) 2026 due to abdominal pain.The patient was admitted to the hospital and diagnosed with peritonitis.Pd cultures were obtained.The patient was initiated on antibiotic therapy with intraperitoneal (ip) vancomycin every 5 days from (b)(6) 2026 (dose not provided).The cultures were positive for coagulase-negative staphylococcus warneri.The discharge date was not confirmed.The cause of the peritonitis event was touch contamination.The patient continued ccpd treatments during recovery.

• 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: 25860860
• Report Number: 0008030665-2026-01911
• Device Sequence Number: 17459497
• 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: Consumer,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/29/2026

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: 07/20/2026; 09/28/2026
• Initial Report FDA Received Date: 07/17/2026
• Supplement Report FDA Received Date: 07/27/2026; 09/29/2026
• 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 Age: 51 YR
• Patient Sex: Female
• Patient Weight: 176 LB