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); Fever (1858); Peritonitis (2252)

Event Date 03/28/2024

Event Type  Injury  

Event Description

On (b)(6) 2024, this peritoneal dialysis (pd) patient on continuous cyclic pd (ccpd) therapy utilizing the liberty select cycler reported to fresenius technical services they needed to discontinue a pd treatment to go to the hospital for a fever.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 fever, abdominal pain and cloudy peritoneal effluent fluid.It was explained laboratory testing was conducted in the hospital but not reported to the outpatient clinic as the patient was still awaiting discharge to home.The patient was diagnosed with peritonitis due to unknown etiology.The patient was prescribed intravenous levofloxacin at 500 mg daily to address this infection while hospitalized.The patient has been able to undergo ccpd therapy on a hospital provided cycler (unknown brand and model) for the duration of the admission.The patient is recovering from this event while awaiting discharge home.It was confirmed, though the exact cause of this 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 plans to continue ccpd therapy on the same liberty select cycler at home upon discharge.

• 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: 19066475
• MDR Text Key: 339671515
• Report Number: 3023981687-2024-00092
• 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
• Type of Report: Initial
• Report Date: 04/08/2024

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
• Device Operator: Lay User/Patient
• Device Catalogue Number: 050-87216
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/08/2024
• Distributor Facility Aware Date: 03/28/2024
• Device Age: MO
• Date Report to Manufacturer: 04/08/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/08/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DELFLEX PD FLUID; LIBERTY SELECT CYCLER
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 68 KG