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 Peritonitis (2252); Malaise (2359); Constipation (3274)

Event Date 12/20/2023

Event Type  Injury  

Event Description

During follow-up for an unrelated cycler alarm that occurred during this patient¿s peritoneal dialysis (pd) treatment on 18/dec/2023, it was reported by the patient that they went to the emergency room (er) due to feeling sick.No further details were provided by the patient.Additional follow-up with the patient¿s pd registered nurse (pdrn) confirmed the patient was admitted to the hospital with a diagnosis of peritonitis.The patient was admitted to the hospital on (b)(6) 2023 due to unspecified symptoms and was diagnosed with peritonitis and constipation.A pd effluent culture was obtained.The patient was administered antibiotic therapy with intraperitoneal (ip) vancomycin (dose, frequency, and duration unknown).The patient¿s white blood cell (wbc) count was elevated to 800 (unknown units).The pd cultures resulted negative for growth; however, initially it was thought the peritonitis would be a gram-negative infection based on the patient¿s concomitant constipation.The patient was discharged on (b)(6) 2023 and continues to complete antibiotic therapy during recovery.The patient is reportedly new to pd therapy.The cause of the patient¿s peritonitis could not be determined.

• 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: 18508547
• MDR Text Key: 332871032
• Report Number: 3023981687-2024-00015
• 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: 01/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2024
• 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: 01/12/2024
• Distributor Facility Aware Date: 12/22/2023
• Device Age: MO
• Event Location: Home
• Date Report to Manufacturer: 01/12/2024
• Date Manufacturer Received: 12/22/2023
• 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: 72 YR
• Patient Sex: Female