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 Code	Peritonitis (2252)
Date of Event	10/25/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A peritoneal dialysis registered nurse (pdrn) reported that a peritoneal dialysis (pd) patient was diagnosed with an infection on pd catheter (not a fresenius product).Additional information was obtained through follow-up with the pdrn.The patient went to the emergency room (er) on (b)(6) 2023.No symptoms were provided.The patient was diagnosed with peritonitis.It was confirmed this was not a pd catheter infection.The patient was initiated on antibiotic therapy with intraperitoneal (ip) vancomycin and ceftazidime (dose, frequency, and duration not provided).No culture results were available.The patient¿s hospital records have not been received by the clinic.The clinic has not been able to obtain information from the patient, who has been difficult to get in touch with since the er visit.The patient is reportedly not completing pd treatments.The patient stated the hospital instructed her not to complete pd treatments.The pdrn stated the hospital would not instruct the patient to withhold dialysis.The patient has a history of non-compliance with treatments.Therefore, it is unknown if the patient is compliant with the antibiotic therapy.The cause of the peritonitis has not been confirmed due to the culture results not being available.

• 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: 18124508
• Report Number: 3023981687-2023-00265
• Device Sequence Number: 6403526
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/13/2023
• Report Date (Section F): 11/13/2023

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/25/2023
• Device Age: MO
• Event Location: Home
• Date Report to Manufacturer: 11/13/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/13/2023
• 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 CYCLER SET
• Patient Age: 35 YR
• Patient Sex: Female
• Date Report Sent to FDA: 11/13/2023