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); Peritoneal effluent abnormal (4904)
Date of Event	04/17/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis [cc(pd)] utilizing a liberty select cycler and liberty cycler set for renal replacement therapy (rrt) was diagnosed with peritonitis, due to failing to place a staysafe end cap on the pd catheter (not a fresenius product) at the termination of treatment.Follow-up with the patients¿ 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 = 719 u/l, neutrophils = 62%) were collected, and the patient was formally admitted.The patient was diagnosed with peritonitis and was treated with intraperitoneal (ip) vancomycin and ceftazidime for 14 days.The patient¿s peritoneal effluent culture result returned negative for growth; however, the patient¿s vancomycin and ceftazidime were continued.The patient continued to undergo ccpd while hospitalized and was discharged in stable condition on (b)(6) 2025.The patient is recovering from the serious adverse events, and resumed utilizing the same liberty select cycler at home without reported issues.The pdrn attributed causality to a breach in sterility, as the patient failed to place a staysafe end cap on her pd catheter (not a fresenius product) at the end of treatment.Per the pdrn, the events were not caused by any fresenius product(s) and/or device(s) deficiency or malfunction.

• 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: 21927703
• Report Number: 3023981687-2025-00005
• Device Sequence Number: 9021772
• Product Code: KDJ
• UDI-Device Identifier: 00840861100835
• UDI-Public: 00840861100835
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 04/29/2025
• Report Date (Section F): 04/29/2025

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: 04/22/2025
• Device Age: MO
• Event Location: Home
• Date Report to Manufacturer: 04/29/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/29/2025
• 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: DELFLEX PD FLUID; LIBERTY CYCLER SET ; LIBERTY SELECT CYCLER
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 70 YR
• Patient Sex: Female
• Date Report Sent to FDA: 04/29/2025