MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. LIBERTY CYCLER SET, SINGLE PATIENT CONN; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number	050-87215A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Peritonitis (2252); Peritoneal effluent abnormal (4904)
Date of Event	12/20/2025
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: a temporal relationship exists between ccpd therapy utilizing the liberty cycler set and the adverse event of peritonitis, characterized by abdominal pain and cloudy peritoneal effluent fluid.It is well established that pd patients are at high risk for peritoneum infections.The root cause of this patient¿s infection can be attributed to a break in aseptic technique during pd therapy with no indication of a contributing deficiency or malfunction of any fresenius product(s) or device(s) as reported by a medical professional.Nonadherence to asepsis during pd is the leading source of transmission of peritonitis causing pathogens.This is further evidenced by the presence of a microorganism that is part of the normal flora of human gastrointestinal (gi), genitourinary (gu) and aerodigestive tracts.Therefore, the liberty cycler set can be excluded as a potential 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.
Event or Problem Description
A peritoneal dialysis registered nurse [(pd)rn] reported to fresenius customer service that this peritoneal dialysis (pd) patient on continuous cyclic pd (ccpd) therapy utilizing the liberty select cycler was hospitalized with 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 was hospitalized on (b)(6) 2025 following abdominal pain and cloudy peritoneal effluent fluid noted at home.Peritoneal effluent fluid cultures and a white blood cell (wbc) count obtained and tested in the hospital on (b)(6) 2025 presented with klebsiella pneumoniae in the culture and a wbc count of approximately 6000/mm3 (exact count not reported).The patient was diagnosed with peritonitis due to a break aseptic technique during ccpd therapy on the liberty select cycler art home.The patient was prescribed intraperitoneal (ip) vancomycin at 2000 mg and ip ceftazidime at 2000 mg (frequencies not reported) to address the infection while hospitalized.The patient has been able to undergo ccpd therapy on a hospital-provided baxter cycler (not a fresenius product) for the duration of the admission.The patient is recovering from this event as he remains admitted and awaiting discharge home.It was reported that the patient¿s peritonitis and associated hospitalization were not the result of a deficiency or malfunction of any fresenius product(s) or device(s).The patient will remain on ccpd therapy on the same liberty select cycler at home upon discharge.
Additional Manufacturer Narrative
Plant investigation: the sample was not returned to the manufacturer and the lot number was not provided.A manufacturing review was performed on the products shipped to the patient for the three (3) month time frame which immediately preceded the event occurrence date.This review included the lot numbers for all fresenius liberty 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 device history records (dhr) was conducted and confirmed that the results of the in-progress and final quality control (qc) testing met all requirements.The product lots involved met all specifications for release.A review of the dhr did not reveal a probable cause for the customer complaint.There is no allegation of cassette malfunction based in the complaint description and information provided, the reported peritonitis was attributed to a breach in aseptic technique.There is no allegation of cassette malfunction.As there is no allegation related to product manufacture, the complaint is deemed unconfirmed.
Event or Problem Description
A peritoneal dialysis registered nurse [(pd)rn] reported to fresenius customer service that this peritoneal dialysis (pd) patient on continuous cyclic pd (ccpd) therapy utilizing the liberty select cycler was hospitalized with 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 was hospitalized on (b)(6) 2025 following abdominal pain and cloudy peritoneal effluent fluid noted at home.Peritoneal effluent fluid cultures and a white blood cell (wbc) count obtained and tested in the hospital on (b)(6) 2025 presented with klebsiella pneumoniae in the culture and a wbc count of approximately 6000/mm3 (exact count not reported).The patient was diagnosed with peritonitis due to a break aseptic technique during ccpd therapy on the liberty select cycler art home.The patient was prescribed intraperitoneal (ip) vancomycin at 2000 mg and ip ceftazidime at 2000 mg (frequencies not reported) to address the infection while hospitalized.The patient has been able to undergo ccpd therapy on a hospital-provided baxter cycler (not a fresenius product) for the duration of the admission.The patient is recovering from this event as he remains admitted and awaiting discharge home.It was reported that the patient¿s peritonitis and associated hospitalization were not the result of a deficiency or malfunction of any fresenius product(s) or device(s).The patient will remain on ccpd therapy on the same liberty select cycler at home upon discharge.

• Brand Name: LIBERTY CYCLER SET, SINGLE PATIENT CONN
• 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 ; 6174175172
• MDR Report Key: 23959846
• Report Number: 0008030665-2026-00018
• Device Sequence Number: 17545762
• Product Code: FKX
• UDI-Device Identifier: 00840861102709
• UDI-Public: 00840861102709
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 03/12/2026

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: 050-87215A
• 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: 12/22/2025
• Supplement Date Received by Manufacturer: 03/11/2026
• Initial Report FDA Received Date: 01/05/2026
• Supplement Report FDA Received Date: 03/12/2026
• 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; DELFLEX PD FLUID; LIBERTY SELECT CYCLER; LIBERTY SELECT CYCLER
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 70 KG