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	06/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On 10/jul/2024, a patient contact reported to fresenius customer service this peritoneal dialysis (pd) patient on continuous cyclic pd (ccpd) therapy utilizing the liberty select cycler experienced an infection and was hospitalized.There was no specific allegation this adverse event was related to a deficiency or malfunction of any fresenius product(s) or device(s) in the initial reporting.Upon follow up with the patient¿s pd registered nurse, it was reported this patient was hospitalized on (b)(6) 2024 following abdominal pain and cloudy peritoneal effluent fluid.Peritoneal effluent fluid cultures and a white blood cell (wbc) count taken in the hospital on 29/jun/2024 presented with candida parapsilosis in the culture and an elevated wbc count (exact count not reported).The patient was diagnosed with peritonitis due to unknown etiology.The patient was prescribed intraperitoneal vancomycin at 2000 mg every three days for two weeks and oral fluconazole at 200 mg daily for two weeks.The patient¿s pd catheter was removed due to the nature of this fungal infection.The patient received a central vascular catheter in favor of hemodialysis (hd) as the patient was transitioned to hd for renal replacement therapy on a hospital provided hd device for the duration of admission.The patient had an uneventful hospital course and was discharged to home on (b)(6) 2024.It was confirmed, though the exact cause of this patient¿s infection remains unknown, there was no indication the peritonitis and associated hospitalization were due to a deficiency or malfunction of any fresenius product(s) or device(s).The patient recovered from this event as he remains on hd therapy on an in-center basis post-discharge, and he plans to return to pd therapy on the same liberty select cycler.

• 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: 19797149
• Report Number: 3023981687-2024-00206
• Device Sequence Number: 7077426
• Product Code: FKX
• UDI-Device Identifier: 00840861100743
• UDI-Public: 00840861100743
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 07/22/2024
• Report Date (Section F): 07/22/2024

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: 07/10/2024
• Device Age: MO
• Event Location: Home
• Date Report to Manufacturer: 07/22/2024
• Initial Date Received by Manufacturer: Not provided
• Initial 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: DELFLEX PD FLUID; LIBERTY SELECT CYCLER
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 64 KG
• Date Report Sent to FDA: 07/22/2024