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	Abdominal Pain (1685); Peritonitis (2252); Abdominal Distention (2601); Peritoneal effluent abnormal (4904)
Date of Event	08/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A peritoneal dialysis registered nurse "[(pd)rn]" reported a pd patient on continuous cyclic pd (ccpd) therapy utilizing the liberty select cycler experienced peritonitis.There was no specific allegation that this event was related to a deficiency or malfunction of any fresenius device(s) or product(s) in the initial reporting.Upon follow-up with the patient¿s pdrn, it was reported that this patient presented to the outpatient clinic on (b)(6) 2026 following abdominal pain, bloating with gas and turbid, discolored peritoneal effluent fluid.Peritoneal effluent fluid cultures and a white blood cell (wbc) count obtained in the outpatient clinic on (b)(6) 2026 presented with staphylococcus epidermidis in the culture and a wbc count of 3925/mm3.The patient was diagnosed with peritonitis due to a break in asepsis during ccpd therapy on the liberty select cycler at home.The clinic discovered the patient was reusing disposables during pd that are meant for one-time use.The patient was not hospitalized for this event and prescribed intraperitoneal (ip) vancomycin at 2000 mg every four days for two weeks to address the infection at home.The patient is recovering from this event as he remains asymptomatic on his antibiotic regimen.It was reported that the patient¿s peritonitis was not the result of a deficiency or malfunction of any fme product(s) or device(s).The patient continues ccpd therapy on the same liberty select cycler at home as before this event.
Additional Manufacturer Narrative
Clinical review: a temporal relationship exists between ccpd therapy utilizing the liberty cycler set and the adverse event of peritonitis, characterized by abdominal pain, bloating with gas and abnormal 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 breach in asepsis during pd therapy with no indication of a causal or contributing malfunction or deficiency of any fresenius product(s) or device(s) as reported by a medical professional.A majority of peritonitis infections are the result of contamination to the pd catheter or connections by the patient or caretaker.This is further evidenced by the presence of a microorganism that is part of the normal flora of human hands and skin.Therefore, the liberty cycler set can be excluded as a source or contributor to this patient¿s adverse event.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.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

• 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: 50311574
• Report Number: 0008030665-2026-02235
• Device Sequence Number: 21025231
• Product Code: FKX
• UDI-Device Identifier: 00840861102716
• UDI-Public: 00840861102716
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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,Followup
• Report Date (Section B): 09/22/2026

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?: Yes
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2026
• Supplement Date Received by Manufacturer: 09/18/2026
• Initial Report FDA Received Date: 08/18/2026
• Supplement Report FDA Received Date: 09/22/2026
• 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: 167 LB