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	11/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported during follow up that this peritoneal dialysis (pd) patient on continuous cyclic pd (ccpd) therapy utilizing the liberty select cycler experienced peritonitis.There was no specific allegation these adverse events were due to a deficiency or malfunction of any fresenius product(s) or device(s) in the initial reporting.Upon follow-up with this patient¿s pd registered nurse, it was reported this patient presented to the outpatient clinic on (b)(6) 2024 following abdominal pain and cloudy peritoneal effluent fluid noted at home.Peritoneal effluent fluid cultures and a white blood cell (wbc) count taken in the outpatient clinic on (b)(6) 2024 presented with gram-negative bacilli (organism not reported) in the culture and a wbc count of 1700/mm3.The patient was diagnosed with peritonitis due to a break in asepsis to his pd catheter (not a fresenius product).It was explained the patient was found not to have the stay-safe cap on his catheter on multiple occasions prior to this infection.There was no indication of an issue with the patient¿s catheter stay-safe cap, rather it was determined the cap was not appropriately replaced by the patient following therapy.The patient was not hospitalized for this event and prescribed intraperitoneal (ip) vancomycin at 2000 mg every 5 days for two weeks and ip ceftazidime at 2000 mg daily for two weeks.The patient recovered from this event at home on antibiotic therapy.It was confirmed the patient¿s peritonitis was not due to a deficiency or malfunction of any fresenius product(s) or device(s).The patient remains on ccpd therapy on a newly received liberty select cycler at home.

• 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: 21103392
• Report Number: 3023981687-2025-00001
• Device Sequence Number: 12927798
• Product Code: KDJ
• UDI-Device Identifier: 00840861100835
• UDI-Public: 00840861100835
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 01/08/2025
• Report Date (Section F): 01/08/2025

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: 12/30/2024
• Device Age: MO
• Event Location: Home
• Date Report to Manufacturer: 01/08/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/08/2025
• 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 SELECT CYCLER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 79 KG
• Date Report Sent to FDA: 01/08/2025