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	06/14/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a peritoneal dialysis (pd) patient was diagnosed with a staphylococcus aureus and peritonitis infection.Follow-up with the patient¿s pd registered nurse (pdrn) revealed the patient presented to the outpatient home dialysis clinic on 14/jun/2024 with complaints of abdominal pain, abdominal cramping, and cloudy peritoneal effluent fluid.A peritoneal effluent fluid culture and cell count (wbc = 412 u/l, neutrophils = 85%) were collected, and the patient was diagnosed with peritonitis.The patient was treated as an outpatient with intraperitoneal (ip) vancomycin 2000 mg every 5 days, and fortaz 2000 mg daily for 21 days.The patient¿s peritoneal effluent culture result returned positive for staphylococcus aureus on 19/jun/2024, and the patient¿s vancomycin and fortaz were discontinued and replaced with cefazolin 2000 mg daily for 21 days.The patient is recovering from the serious adverse events and continues to undergo ccpd therapy at home utilizing the same liberty select cycler without reported issue.The pdrn attributed causality to a touch contamination event, as the patient reported experiencing difficulty opening the stay-safe-cap packaging and touched the caps¿ threading in the process.Per the pdrn, the events were not caused by any fresenius product(s) and/or device(s) deficiency or malfunction.However, the pdrn expressed concern regarding the strength required to open the packaging could lead to similar events given the patient population.

• 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: 19666902
• Report Number: 3023981687-2024-00177
• Device Sequence Number: 6624280
• Product Code: KDJ
• UDI-Device Identifier: 00840861100835
• UDI-Public: 00840861100835
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/03/2024
• Report Date (Section F): 07/03/2024

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/27/2024
• Device Age: MO
• Event Location: Home
• Date Report to Manufacturer: 07/03/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/03/2024
• 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
• Patient Age: 31 YR
• Patient Sex: Female
• Patient Weight: 106 KG
• Date Report Sent to FDA: 07/03/2024