BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEVEL 1 FLUID WARMER ACCESSORY

    MDR report key: 12024867 · Received June 18, 2021

    Report

    Report Number
    3012307300-2021-06250
    Event Type
    Malfunction
    Date Received
    June 18, 2021
    Date of Event
    May 21, 2021
    Report Date
    June 18, 2021
    Manufacturer
    ST PAUL
    Product Code
    KZL
    UDI-DI
    20695085410017
    PMA / PMN Number
    BK860023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PHONE: (B)(6).

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL FLUID WARMER ACCESSORY WAS LEAKING. THERE WAS NO INJURY AND NO REPORTED ADVERSE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    920130 LEVEL 1 FLUID WARMER ACCESSORY DEVICE, WARMING. BLOOD AND PLASMA KZL ST PAUL DI-100 3887775 20695085410017

    Patients

    Seq Age Sex Outcome Treatment
    1