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)
Date of Event	02/19/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A peritoneal dialysis registered nurse (pdrn) reported to fresenius customer support that a patient has peritonitis and is in the hospital at this time.The patient got the infection on (b)(6) and still has it.The patient will be on antibiotics for 14 days.The patient still has the pd catheter (not a fresenius device).Follow-up with the patient¿s pd registered nurse (pdrn) confirmed the patient presented to the emergency room on (b)(6) 2025 with complaints of abdominal pain and cloudy peritoneal effluent fluid.A peritoneal effluent fluid culture and cell count (wbc elevated, result not provided) were collected, and the patient was admitted.The patient was diagnosed with peritonitis and was treated with intraperitoneal (ip) vancomycin and fortaz for 14 days.The patient¿s peritoneal effluent culture result returned positive for staphylococcus aureus on (b)(6) 2025, and the patient's fortaz was discontinued.The patient has recovered from the serious adverse events and continued to undergo ccpd therapy while hospitalized.The patient was discharged home on (b)(6) 2025 in stable condition, and resumed utilizing the same liberty select cycler without any reported issues.The pdrn attributed causality to an unspecified touch contamination event.Per the pdrn, the events were not caused by any fresenius product(s) and/or device(s) deficiency or malfunction.
Additional Manufacturer Narrative
Clinical investigation: a temporal relationship exists between ccpd therapy utilizing the liberty cycler set and the serious adverse events of peritonitis, characterized by abdominal pain and cloudy peritoneal effluent fluid, which required antibiotic therapy.The pdrn attributed causality to an unspecified touch contamination event.Esrd patients undergoing pd therapy (manual or cycler based) for rrt are at high risk for infections of the peritoneum.Staphylococcus aureus is commonly found in the mucus membranes and skin of humans and is the most frequent organism associated with peritoneal infections in pd patients.Per the pdrn, the serious adverse events were not caused by any fresenius product(s) and/or device(s) deficiency or malfunction.Based on the information available, the patient¿s liberty cycler set can be disassociated from the serious adverse events.There is no allegation or objective evidence indicating a fresenius device(s) and/or product(s) caused or contributed to the serious adverse events.Furthermore, there was no report that a fresenius device(s) and/or product(s) failed to meet the users¿ expectations and/or the manufacturers¿ specifications.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
Event or Problem Description
A peritoneal dialysis registered nurse (pdrn) reported to fresenius customer support that a patient has peritonitis and is in the hospital at this time.The patient got the infection on (b)(6) and still has it.The patient will be on antibiotics for 14 days.The patient still has the pd catheter (not a fresenius device).Follow-up with the patient¿s pd registered nurse (pdrn) confirmed the patient presented to the emergency room on (b)(6) 2025 with complaints of abdominal pain and cloudy peritoneal effluent fluid.A peritoneal effluent fluid culture and cell count (wbc elevated, result not provided) were collected, and the patient was admitted.The patient was diagnosed with peritonitis and was treated with intraperitoneal (ip) vancomycin and fortaz for 14 days.The patient¿s peritoneal effluent culture result returned positive for staphylococcus aureus on (b)(6) 2025, and the patient¿s fortaz was discontinued.The patient has recovered from the serious adverse events and continued to undergo ccpd therapy while hospitalized.The patient was discharged home on (b)(6) 2025 in stable condition, and resumed utilizing the same liberty select cycler without any reported issues.The pdrn attributed causality to an unspecified touch contamination event.Per the pdrn, the events were not caused by any fresenius product(s) and/or device(s) deficiency or malfunction.
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.

• 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: 21529229
• Report Number: 0008030665-2025-00525
• Device Sequence Number: 18537987
• Product Code: FKX
• UDI-Device Identifier: 00840861102709
• UDI-Public: 00840861102709
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 04/28/2025

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: 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: 02/27/2025
• Supplement Date Received by Manufacturer: 04/26/2025
• Initial Report FDA Received Date: 03/05/2025
• Supplement Report FDA Received Date: 04/28/2025
• 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: Required Intervention; Hospitalization
• Patient Sex: Female