MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. LIBERTY CYCLER SET, SINGLE PATIENT CONN; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number	050-87215
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	11/07/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On 29/nov/2023, this patient on peritoneal dialysis (pd) therapy reported she had peritonitis the first week of november.There were no reported allegations that the peritonitis was related to any issues with fresenius products.The patient reported she was not hospitalized and received antibiotic treatment.In additional follow-up, the patient¿s pd nurse confirmed that on (b)(6) 2023, the patient was seen in the outpatient pd clinic for symptoms of abdominal pain.The patient had a pd culture obtained which grew the bacteria streptococcus mitis.The patient was treated with intra-peritoneal (ip antibiotic therapy with vancomycin (dose not provided) and ceftazidime (dose not provided) on an outpatient basis.The patient has recovered and is completing pd treatment with the same cycler.The nurse confirmed the patient did not have any fluid leaks or any issues with fresenius products in relation to the peritonitis event.The nurse attributed the peritonitis to a breach in aseptic technique as the patient was not wearing a mask during the pd procedure.

• Brand Name: LIBERTY CYCLER SET, SINGLE PATIENT CONN
• Common Device Name: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): ERIKA DE REYNOSA, S.A. DE C.V.; mike allen #1331; parque industrial reynosa; reynosa 88780 ; MX 88780
• MDR Report Key: 18294945
• Report Number: 3023981687-2023-00287
• Device Sequence Number: 12521441
• Product Code: FKX
• UDI-Device Identifier: 00840861100743
• UDI-Public: 00840861100743
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K173718
• 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): 12/08/2023
• Report Date (Section F): 12/08/2023

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 Catalogue Number: 050-87215
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/29/2023
• Device Age: MO
• Event Location: Home
• Date Report to Manufacturer: 12/08/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/08/2023
• 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: 69 YR
• Patient Sex: Female
• Date Report Sent to FDA: 12/08/2023