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	07/10/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2024 during follow-up, fresenius became aware 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 hospitalized due to drain complications and peritonitis.No additional information was provided during intake.During follow-up, the patient¿s pd registered nurse (pdrn) confirmed the patient presented to the emergency room (er) on 12/jul/2024 with complaints of abdominal pain and cloudy peritoneal effluent fluid.A peritoneal effluent fluid culture and cell count (results unavailable) were collected, and the patient was diagnosed with peritonitis.The patient was admitted and treated with intraperitoneal (ip) vancomycin 2000 mg every 3 days, and gentamycin 160 mg daily (due to ceftazidime allergy) for 21 days.The patient¿s peritoneal effluent culture result returned positive for staphylococcus aureus on (b)(6) 2024, and the patient¿s gentamycin was discontinued.The patient continued to undergo ccpd therapy while hospitalized and is recovering from the serious adverse events.The patient was discharged home on 19/jul/2024 in stable condition and resumed ccpd at home utilizing a replacement liberty select cycler.The pdrn attributed causality to a touch contamination event, as the patient admitted to using a stay-safe-cap after it had been dropped on the ground.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: 19827623
• Report Number: 3023981687-2024-00211
• Device Sequence Number: 20998968
• Product Code: KDJ
• UDI-Device Identifier: 00840861100835
• UDI-Public: 00840861100835
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 07/25/2024
• Report Date (Section F): 07/25/2024

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 Expiration Date: 11/30/2024
• Device Catalogue Number: 050-95012
• Device Lot Number: E1ZM021
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/12/2024
• Device Age: MO
• Event Location: Home
• Date Report to Manufacturer: 07/25/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/25/2024
• Date Device Manufactured: 03/06/2024
• 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: Required Intervention; Hospitalization
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 135 KG
• Date Report Sent to FDA: 07/25/2024