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	11/08/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient's contact reported that this patient on pd therapy has peritonitis.There were no reported allegations that the peritonitis was related to any issues with products.In additional follow-up, the pd nurse stated the patient was having symptoms of abdominal pain and cloudy pd effluent.As a result, on 8/nov/2023, the patient was seen in the outpatient pd clinic.The patient had a pd culture obtained which grew candida tropicalis.The nurse stated the patient is being treated with antibiotic therapy using oral fluconazole (dose unknown) and intravenous vancomycin and ceftazidime (dose unknown) on an outpatient basis.Additionally, the patient was transitioned to back up hemodialysis for renal replacement needs and will undergo removal of the pd catheter (not a fresenius product).The patient¿s nurse was not able to identify the exact cause of the patient¿s peritonitis is unknown.However, the nurse confirmed the patient did not have any fluid leaks or issues with fresenius products in relation to this event.The nurse reported the patient is recovering from peritonitis event.
Additional Manufacturer Narrative
Correction: a.1.,a.5.,a.6.,b.1.,b.2.
Event or Problem Description
A patient's contact reported that this patient on pd therapy has peritonitis.There were no reported allegations that the peritonitis was related to any issues with products.In additional follow-up, the pd nurse stated the patient was having symptoms of abdominal pain and cloudy pd effluent.As a result, on (b)(6) 2023, the patient was seen in the outpatient pd clinic.The patient had a pd culture obtained which grew candida tropicalis.The nurse stated the patient is being treated with antibiotic therapy using oral fluconazole (dose unknown) and intravenous vancomycin and ceftazidime (dose unknown) on an outpatient basis.Additionally, the patient was transitioned to back up hemodialysis for renal replacement needs and will undergo removal of the pd catheter (not a fresenius product).The patient¿s nurse was not able to identify the exact cause of the patient¿s peritonitis is unknown.However, the nurse confirmed the patient did not have any fluid leaks or issues with fresenius products in relation to this event.The nurse reported the patient is recovering from peritonitis event.

• 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: 18234118
• Report Number: 3023981687-2023-00279
• Device Sequence Number: 3226020
• Product Code: FKX
• UDI-Device Identifier: 00840861100743
• UDI-Public: 00840861100743
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 04/04/2024
• Report Date (Section F): 04/04/2024

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: 050-87215
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/04/2024
• Device Age: MO
• Event Location: Home
• Date Report to Manufacturer: 04/04/2024
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 04/04/2024
• Initial Report FDA Received Date: 11/29/2023
• Supplement Report FDA Received Date: 04/04/2024
• 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; DELFLEX PD FLUID; LIBERTY SELECT CYCLER; LIBERTY SELECT CYCLER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Date Report Sent to FDA: 04/04/2024