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); Fatigue (1849); Peritonitis (2252)

Event Date 07/27/2023

Event Type  Injury  

Event Description

On (b)(6) 2023 it was reported that this patient was hospitalized for peritonitis due to poor technique.This was the patient¿s third peritonitis event.Additional information was provided through follow-up with the patient¿s peritoneal dialysis registered nurse (pdrn).The patient presented to the peritoneal dialysis (pd) clinic on (b)(6) 2023 with complaints of abdominal pain and fatigue.A pd effluent culture was obtained, and the patient was diagnosed with peritonitis.The patient was initiated on antibiotic therapy with one dose of intraperitoneal (ip) vancomycin 1750mg on (b)(6) 2023 and ip cefepime 2g one dose on (b)(6) 2023 and another on (b)(6) 2023.Additionally, the patient was administered ip meropenem 1g daily from (b)(6) 2023 through (b)(6) 2023 (used due to antibiotics availability).The patient¿s white blood cell (wbc) count on (b)(6) 2023 was 360 and on (b)(6) 2023 it was 583.At that time the doctor changed the antibiotic to ceftazidime 2g daily due to the rising wbc.Another wbc on (b)(6) 2023 was 392.The culture resulted positive for klebsiella pneumoniae.On (b)(6) 2023 the pdrn sent the patient to the emergency room (er) where the patient was admitted.The hospital obtained pd cultures and the patient¿s wbc was nucleated cells 10 and fluid 120.The new cultures obtained on (b)(6) 2023 were positive for candida albicans (moderate growth), candida fermentati (moderate growth), and mold (rare growth).The patient was administered a one-time dose of ip eraxis 200mg on (b)(6) 2023.The patient¿s antibiotics were then changed to ip eraxis 100mg daily from (b)(6) 2023 until present and intravenous (iv) ceftriaxone 1000mg every 24 hours from (b)(6) 2023 until present.The patient had his pd catheter (not a fresenius product) removed on (b)(6) 2023.The patient is not continuing with pd therapy.The patient remains hospitalized.The cause of the peritonitis event is attributed to touch contamination.No further information was provided.

• 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: 17627112
• MDR Text Key: 321992073
• Report Number: 3023981687-2023-00181
• 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: 08/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2023
• 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: 08/25/2023
• Distributor Facility Aware Date: 08/15/2023
• Device Age: MO
• Event Location: Home
• Date Report to Manufacturer: 08/25/2023
• Date Manufacturer Received: 08/15/2023
• 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: 92 KG