MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. STAY SAFE/LUER LOCK CATHETER EXT. 12 IN.; SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

Model Number	050-95004
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	02/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A peritoneal dialysis (pd) patient on continuous cycling peritoneal dialysis (ccpd) for renal replacement therapy (rrt) contacted customer support and reported they got peritonitis while on the machine.Upon follow up, the peritoneal dialysis registered nurse (pdrn) stated that the patient presented to the outpatient home dialysis unit on (b)(6) 2023 with complaints of abdominal pain and cloudy peritoneal effluent fluid.A peritoneal effluent fluid culture and cell count (wbc = 3305 u/l, polymorphs = 88%) were collected, and the patient was diagnosed with peritonitis.The patient was treated as an outpatient with intraperitoneal (ip) vancomycin (per vancomycin level) and ceftazidime 1500 mg daily for 14-21 days.The patient¿s peritoneal effluent culture result returned negative for growth on (b)(6) 2023, and the patient¿s antibiotics were continued.The patient continues to undergo continuous cyclic pd (ccpd) utilizing the same liberty select cycler and is recovering from the serious adverse events.The pdrn attributed causality to a disconnection event, when the patient¿s pd catheter extension set disconnected from the liberty cycler set due to inadequate tightening.The patient reported the liberty cycler set fell to the floor, and they reconnected without utilizing a new set-up.Per the pdrn, the events were unrelated to any fresenius product(s), drug(s), and/or device(s) deficiency or malfunction.

• Brand Name: STAY SAFE/LUER LOCK CATHETER EXT. 12 IN.
• 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: 16491560
• Report Number: 3023981687-2023-00050
• Device Sequence Number: 6787680
• Product Code: KDJ
• UDI-Device Identifier: 00840861100781
• UDI-Public: 00840861100781
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K173593
• 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): 03/06/2023
• Report Date (Section F): 03/06/2023

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 Model Number: 050-95004
• Device Catalogue Number: 050-95004
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/27/2023
• Device Age: MO
• Event Location: Home
• Date Report to Manufacturer: 03/06/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/06/2023
• 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: Female
• Patient Weight: 47 KG
• Date Report Sent to FDA: 03/06/2023