BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BREG

    MDR report key: 11684624 · Received April 19, 2021

    Report

    Report Number
    11684624
    Event Type
    Malfunction
    Date Received
    April 19, 2021
    Date of Event
    March 19, 2021
    Report Date
    April 8, 2021
    Manufacturer
    BREG, INC.
    Product Code
    ILO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ME
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PATIENT STATUS POST RIGHT KNEE ARTHROSCOPIC SURGERY CAME TO RECOVERY ROOM WITH A BREG POLAR CARE CUBE. CNA FILLED THE MACHINE WITH ICE AND WATER AND ATTACHED THE TUBING TO THE COOLING PAD WHICH WAS ALREADY ON THE PATIENT'S RIGHT KNEE (UNDER A BRACE). WHEN THE PATIENT'S MOTHER ARRIVED TO THE BED SHE MENTIONED THERE WAS WATER ON THE FLOOR. I WENT AROUND TO THAT SIDE OF THE BED AND NOTICED THAT IN ADDITION TO THERE BEING WATER ON THE FLOOR, THE BEDDING WAS WET AND THE PATIENT'S DRESSING WAS SATURATED WITH COLD WATER. I INSPECTED THE TUBING AND COULD SEE WATER WAS LEAKING AT THE CONNECTION SITE OF THE TUBING BETWEEN THE MACHINE AND THE COOLING PAD. THE TUBING APPEARED TO BE CONNECTED PROPERLY. DOCTOR WAS CONTACTED AND HIS PA WAS SENT TO TAKE DOWN AND REPLACE THE PATIENT'S WET DRESSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587791 BREG PACK, HOT OR COLD, WATER CIRCULATING ILO BREG, INC. POLAR CARE CUBE

    Patients

    Seq Age Sex Outcome Treatment
    1 5475 DA