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); Abdominal Cramps (2543)
Date of Event	12/17/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to fresenius customer service that a peritoneal dialysis (pd) patient was hospitalized due to peritonitis.No additional information was provided during the initial reporting.Follow-up with the patient¿s pd registered nurse (pdrn) confirmed the patient presented to the emergency room (er) on (b)(6) 2024 with complaints of abdominal pain, abdominal cramping, and cloudy peritoneal effluent fluid.A peritoneal effluent fluid culture and cell count (wbc = 9,278 u/l, polymorph cells = 97%) were collected, and the patient was diagnosed with peritonitis.The patient was admitted and treated with intraperitoneal (ip) ceftriaxone 1000 mg daily, oral levofloxacin 250 mg every 48 hours, and oral fluconazole 100 mg daily for 18 days.The patient¿s preliminary peritoneal effluent culture result returned positive for klebsiella oxytoca and enterobacter cloacae on (b)(6) 2024, and the patient¿s antibiotics were continued.The pdrn attributed causality to a poorly tightened end cap which became dislodged and leaked fluid.The patient wrapped the pd catheter (not a fresenius product) with non-occlusive paper tape which was saturated upon their arrival to the er.The patient was discharged on (b)(6) 2024 in stable condition and is recovering from the serious adverse events.The patient reportedly continued to undergo continuous cyclic pd (ccpd) therapy while hospitalized, and resumed ccpd at home following discharge utilizing the same liberty select cycler.Per the pdrn, the serious adverse 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: 21175422
• Report Number: 3023981687-2025-00002
• Device Sequence Number: 8537448
• Product Code: KDJ
• UDI-Device Identifier: 00840861100835
• UDI-Public: 00840861100835
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 01/16/2025

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: 01/06/2025
• Device Age: MO
• Event Location: Home
• Date Report to Manufacturer: 01/16/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/16/2025
• 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: 83 YR
• Patient Sex: Male
• Patient Weight: 68 KG
• Date Report Sent to FDA: 01/16/2025