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	04/17/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to fresenius that a patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis [cc(pd)] for renal replacement therapy (rrt) was hospitalized for an unspecified infection, and temporarily transitioned to hemodialysis (hd).During follow-up, the patient¿s pd registered nurse (pdrn) reported the patient presented to the emergency room on (b)(6) 2024 with complaints of abdominal pain and cloudy peritoneal effluent fluid.A peritoneal effluent fluid culture and cell count (wbc elevated) were collected, and the patient was diagnosed with peritonitis.The patient was treated with intraperitoneal (ip) ceftazidime 1500 mg daily, and vancomycin 2000 mg every other day for 21 days.On (b)(6) 2024, the patient¿s peritoneal effluent culture result returned positive for staphylococcus aureus, and the patient¿s ceftazidime and vancomycin were discontinued and replaced with intravenous (iv) rocephin (dosage, frequency, duration not provided).The patient encountered pd catheter (not a fresenius product) issues while hospitalized and required a surgical revision.The patient was temporarily transitioned to hd to allow the patient¿s abdomen time to heal.The patient was discharged on (b)(6) 2024 in stable condition and was recovering from the events.The patient was continuing to undergo incenter hd, and was likely to return to pd therapy the following week.The pdrn attributed causality to an improperly tightened sterile stay safe cap which became dislodged and went undiscovered for approximately 24 hours.Per the pdrn, the events were not related to any fresenius product deficiency and/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: 19316099
• Report Number: 3023981687-2024-00131
• Device Sequence Number: 12660470
• Product Code: KDJ
• UDI-Device Identifier: 00840861100835
• UDI-Public: 00840861100835
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 05/14/2024
• Report Date (Section F): 05/14/2024

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: 05/01/2024
• Device Age: MO
• Event Location: Home
• Date Report to Manufacturer: 05/14/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/14/2024
• 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: Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 148 KG
• Date Report Sent to FDA: 05/14/2024