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 050-87216

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Peritonitis (2252)

Event Date 03/05/2024

Event Type  Injury  

Event Description

A peritoneal dialysis (pd) patient on continuous cyclic pd (ccpd) therapy utilizing the liberty select cycler reported experiencing peritonitis.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.Peritoneal effluent fluid cultures and a white blood cell (wbc) count taken in the hospital on (b)(6) 2024 presented with no growth 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 (ip) vancomycin at 2000 mg and ip ceftazidime at 2000 mg (frequency and duration not reported) to address the infection.The patient¿s pd catheter (not a fresenius product) was removed on (b)(6) 2024 during this hospitalization due to the severity of infection.The patient was transitioned to hemodialysis (hd) for renal replacement therapy through an existing arteriovenous access on a hospital provided hd machine (unknown brand and model) for the duration of the admission.The patient had an uneventful hospital course and was discharged to home on (b)(6) 2024.It was confirmed, though the exact source of infection remains unknown, there was no indication the patient¿s peritonitis, and the associated hospitalization were due to a deficiency or malfunction of any fresenius product(s) or device(s).The patient recovered from this event as remains asymptomatic on antibiotic therapy.The patient continues hd therapy on an in-center basis with a plan to return to pd therapy on the same liberty select cycler once cleared by his physician.

• Brand Name: LIBERTY CYCLER SET, SINGLE CONN./EXT. DL
• Type of Device: 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: 18966487
• MDR Text Key: 338434480
• Report Number: 3023981687-2024-00083
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861100750
• UDI-Public: 00840861100750
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173718
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Report Date: 03/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 050-87216
• Device Lot Number: 23JR08051
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/24/2024
• Distributor Facility Aware Date: 03/08/2024
• Device Age: MO
• Event Location: Home
• Date Report to Manufacturer: 03/24/2024
• Date Manufacturer Received: 03/08/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DELFLEX PD FLUID; LIBERTY SELECT CYCLER
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 73 KG