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 04/11/2024

Event Type  Injury  

Event Description

On (b)(6) 2024, during a follow up, a hospital peritoneal dialysis registered nurse [(pd)rn] reported to fresenius this peritoneal dialysis (pd) patient on continuous cyclic pd (ccpd) therapy utilizing the liberty select cycler was hospitalized for 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 pdrn, it was reported this patient was hospitalized on (b)(6) 2024 following abdominal pain and cloudy peritoneal effluent fluid.Peritoneal effluent fluid cultures taken in the hospital on (b)(6) 2024 presented with klebsiella pneumoniae and a white blood cell (wbc) count of 9271/mm3.The patient was diagnosed with peritonitis due to touch contamination during ccpd therapy on the liberty select cycler at home.The patient was prescribed intraperitoneal (ip) vancomycin and ip ceftazidime initially (unknown dosages and frequency), but the antibiotic was changed to ip meropenem (dosage and frequency unknown) as they experienced nausea with other antibiotics.The patient was able to undergo ccpd therapy on a hospital provided liberty cycler 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 the patient¿s peritonitis, and the associated hospitalization were not due to a deficiency or malfunction of any fresenius product(s) or device(s).The patient recovered from this event as he remains asymptomatic and continues ccpd therapy on the same liberty select cycler at home.

• 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: 19180351
• MDR Text Key: 341019954
• Report Number: 3023981687-2024-00106
• 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: Nurse
• Type of Report: Initial
• Report Date: 04/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 050-87216
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/25/2024
• Distributor Facility Aware Date: 04/17/2024
• Device Age: MO
• Event Location: Home
• Date Report to Manufacturer: 04/25/2024
• Date Manufacturer Received: 04/17/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LIBERTY SELECT CYCLER; PD SOLUTION
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 95 KG