MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. STERILE STAY SAFE CAP; SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

Catalog Number	050-95012
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	01/05/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On 13/jan/2025, fresenius became aware this patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis [cc(pd)] utilizing a liberty select cycler, liberty cycler set and stay safe cap for renal replacement therapy (rrt) contracted peritonitis, and his pd catheter (not a fresenius product) was removed.No additional information was provided during the intake process.Follow-up with the patient¿s pd registered nurse [(pd)rn] 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 (results unavailable) were collected, and the patient was formally admitted.The patient was diagnosed with peritonitis and treated with intraperitoneal (ip) vancomycin 2000 mg every three days and ceftazidime 1500 mg daily for 14 days.The patient¿s peritoneal effluent culture result returned positive for methicillin resistant staphylococcus aureus (mrsa) on (b)(6) 2025, and the patient¿s antibiotics were continued.Upon receiving the peritoneal effluent fluid culture results, the nephrologist ordered the removal of the patient¿s pd catheter on (b)(6) 2025 and a temporary hemodialysis (hd) catheter (not a fresenius product) was surgically placed the same day.The patient transitioned to hd for rrt without any reported issues and will complete the remaining antibiotic course intravenously.The patient was discharged home on (b)(6) 2024 in stable condition and began outpatient hd therapy on (b)(6) 2025.The pdrn attributed causality to the patient¿s reuse of a stay safe end cap.The patient reportedly completed treatment and realized he did not have a replacement cap and reused the pretreatment stay safe end cap.Reeducation was provided.Per the pdrn, the events were unrelated to any fresenius product(s) and/or device(s) deficiency or malfunction.The patient continues to undergo hd on an outpatient basis without any known issues.

• Brand Name: STERILE STAY SAFE CAP
• Common Device Name: SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
• Manufacturer (Section D): ERIKA DE REYNOSA, S.A. DE C.V.; mike allen #1331; parque industrial reynosa; reynosa 88780 ; MX 88780
• MDR Report Key: 21183173
• Report Number: 3023981687-2025-00003
• Device Sequence Number: 11827850
• Product Code: KDJ
• UDI-Device Identifier: 00840861100835
• UDI-Public: 00840861100835
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K083542
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/17/2025
• Report Date (Section F): 01/17/2025

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: 050-95012
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/13/2025
• Device Age: MO
• Event Location: Home
• Date Report to Manufacturer: 01/17/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/17/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LIBERTY CYCLER SET.; LIBERTY SELECT CYCLER.; PD SOLUTION.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 43 YR
• Patient Sex: Male
• Patient Weight: 93 KG
• Date Report Sent to FDA: 01/17/2025