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 02/25/2024

Event Type  Injury  

Event Description

A nurse reported a patient on peritoneal dialysis (pd) therapy was hospitalized for peritonitis.There were no reported allegations that the event was related to fresenius products.In additional follow-up, the patient¿s pd nurse reported that on (b)(6) 2024 the patient was hospitalized with symptoms of abdominal pain.During hospitalization, the patient had a pd culture obtained which yielded an elevated white blood cell (wbc) count and no organism growth.The patient was initiated on intra-peritoneal (ip) antibiotic therapy with vancomycin and ceftazidime (dosing not provided).On (b)(6) 2024, the patient was discharged and is reportedly recovering from peritonitis event.The patient continues pd with the same cycler, per the nurse.The nurse stated the patient did not have any fluid leaks or any issues with fresenius products in relation to the event.The nurse stated the peritonitis was due to a breach in aseptic technique during the pd exchange.

• 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: 18913448
• MDR Text Key: 337773620
• Report Number: 3023981687-2024-00077
• 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: 03/15/2024

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
• Device Lot Number: 23KR08052
• 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: 03/15/2024
• Distributor Facility Aware Date: 02/29/2024
• Device Age: MO
• Event Location: Home
• Date Report to Manufacturer: 03/15/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/15/2024
• 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: 42 YR
• Patient Sex: Male