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 Code	Peritonitis (2252)
Date of Event	06/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical review: there is a possible temporal relationship between pd therapy utilizing the liberty cycler set and the patient event of peritonitis.However, it is unknown if this patient was utilizing fresenius product(s) at the time their reported peritonitis event was diagnosed.There is no patient information and no information to confirm if the patient was a fresenius clinic patient.Furthermore, there is no documentation in the complaint file to show a causal relationship between the peritonitis event and use of the liberty select cycler with cycler set.Additionally, there is no allegation of a device malfunction or deficiency, or cycler set defect reported for the event.All pd patients are at risk of peritonitis due to a compromised immune system and the increase of potential for microbial contamination from dialysis techniques.Most cases of peritonitis are caused by touch contamination by the patient with the pd catheter being a source of entry for organisms into the peritoneum.Based on the limited information and no allegation of a malfunction, deficiency or defect and no confirmation that any fresenius product(s) were utilized, the liberty cycler set can be excluded as the cause of the patient¿s reported peritonitis event.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
Event or Problem Description
A registered nurse (rn) reported to fresenius that this patient had been hospitalized due to peritonitis.The nurse did not recall any additional information regarding the event or the patient.Attempts to obtain additional information from the acute clinic was unsuccessful.
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.As a physical evaluation could not be performed, a definitive conclusion regarding the reported incident could not be reached and a cause could not be confirmed.
Event or Problem Description
A registered nurse (rn) reported to fresenius that this patient had been hospitalized due to peritonitis.The nurse did not recall any additional information regarding the event or the patient.Attempts to obtain additional information from the acutes clinic was unsuccessful.

• 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: 22337645
• Report Number: 0008030665-2025-01460
• Device Sequence Number: 15720706
• Product Code: FKX
• UDI-Device Identifier: 00840861102709
• UDI-Public: 00840861102709
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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): 08/28/2025

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: Health Professional
• 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: 06/19/2025
• Supplement Date Received by Manufacturer: 08/20/2025
• Initial Report FDA Received Date: 06/26/2025
• Supplement Report FDA Received Date: 08/28/2025
• 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 Sex: Unknown