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

Catalog Number	050-87215
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Peritonitis (2252)
Date of Event	06/22/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On 1/jul/2024, it was reported that this patient on peritoneal dialysis (pd) was hospitalized for peritonitis.There were no reported allegations that the event was related to any issues with fresenius products.In additional follow-up, the patient¿s pd nurse confirmed the patient was admitted to the hospital on (b)(6) 2024 for peritonitis.However, the nurse was not able to provide any details about the hospitalization, including pd culture results and treatment information.The nurse stated the patient is being transitioned to hemodialysis for renal replacement needs.The patient remained in the hospital at the time follow-up was performed.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.
Event or Problem Description
On (b)(6) 2024, it was reported that this patient on peritoneal dialysis (pd) was hospitalized for peritonitis.There were no reported allegations that the event was related to any issues with fresenius products.In additional follow-up, the patient¿s pd nurse confirmed the patient was admitted to the hospital on (b)(6) 2024 for peritonitis.However, the nurse was not able to provide any details about the hospitalization, including pd culture results and treatment information.The nurse stated the patient is being transitioned to hemodialysis for renal replacement needs.The patient remained in the hospital at the time follow-up was performed.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.

• Brand Name: LIBERTY CYCLER SET, SINGLE CONN./EXT. DL
• 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: 19748156
• Report Number: 3023981687-2024-00198
• Device Sequence Number: 6532709
• Product Code: FKX
• UDI-Device Identifier: 00840861100743
• UDI-Public: 00840861100743
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2024
• Report Date (Section F): 07/16/2024

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/01/2024
• Device Age: MO
• Event Location: Home
• Date Report to Manufacturer: 07/16/2024
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 07/19/2024
• Initial Report FDA Received Date: 07/16/2024
• Supplement Report FDA Received Date: 07/22/2024
• 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: LIBERTY SELECT CYCLER; LIBERTY SELECT CYCLER; PD SOLUTION; PD SOLUTION
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male
• Date Report Sent to FDA: 07/16/2024