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	Peritonitis (2252); Peritoneal effluent abnormal (4904)
Date of Event	09/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A peritoneal dialysis (pd) patient's wife reported the patient with renal failure (rf) on continuous cyclic peritoneal dialysis \"[cc(pd)]\" utilizing a liberty select cycler and liberty cycler set for renal replacement therapy (rrt) was diagnosed with peritonitis.Follow-up with the patient¿s pd registered nurse (pdrn) revealed the patient presented to the outpatient home dialysis clinic with complaints of cloudy peritoneal effluent fluid.A peritoneal effluent fluid culture and cell count (wbc = 170,700 u/l, polymorphs = 92%) were collected, and the patient was diagnosed with peritonitis.The patient was treated as an outpatient with intraperitoneal (ip) vancomycin 2000 mg and ceftazidime 2000 mg (duration not provided) and continued to undergo ccpd therapy while being treated.The patient¿s peritoneal effluent culture result returned positive for staphylococcus epidermidis (date not provided), and the patient¿s antibiotics were continued.The pdrn stated the patient is recovering but did not provide the cause of the peritonitis.However, the pdrn reported the serious adverse events were not caused by any fme product(s) and/or device(s) deficiency or malfunction.
Additional Manufacturer Narrative
Clinical review: a temporal relationship exists between ccpd therapy utilizing a liberty select cycler, liberty cycler set and the serious adverse events of peritonitis, characterized by cloudy peritoneal effluent fluid,with antibiotic therapy.Pdrn did not provide definitive cause of peritonitis event; however, pdrn did report serious adverse events were not caused by any fme product(s) and/or device(s) deficiency or malfunction.Esrd patients undergoing pd therapy are at high risk for infections of peritoneum.Staphylococcus epidermidis is found in mucus membranes, axillae, and skin of humans, and transmission of bacteria to the peritoneum frequently occurs during touch contamination events.The patient¿s liberty select cycler and liberty cycler set can be disassociated from the serious adverse events.There is no allegation or objective evidence indicating a fme device(s) and/or product(s) caused or contributed to serious adverse events.There is no report a fme device(s) and/or product(s) failed to meet the users¿ expectations and/or manufacturers¿ specifications, as evidenced by the devices¿ continued use.Plant investigation: sample was not returned.Lot number was not provided.Manufacturing review was performed on the products shipped to the patient for the 3 month time frame which immediately preceded the event occurrence date.Review included the lot of cycler sets shipped to this account within the selected time frame.The entire set of lots have been sold and distributed.There were no non-conformances or abnormalities identified during the manufacturing process which could be associated with the reported event.An investigation of the dhr was conducted and confirmed the results of the in-progress and final testing met all requirements.The lots involved met specifications for release.The dhr did not reveal a probable cause for the complaint.A definitive conclusion could not be reached and a cause could not be confirmed.

• 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: 50876521
• Report Number: 0008030665-2026-02561
• Device Sequence Number: 18498348
• Product Code: FKX
• UDI-Device Identifier: 00840861100750
• UDI-Public: 00840861100750
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 09/24/2026

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
• 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: 09/09/2026
• Initial Report FDA Received Date: 09/24/2026
• 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
• Patient Sex: Male
• Patient Weight: 184 LB