BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOEKEL BLOOD COLLECTION MIXER

    MDR report key: 23051238 · Received September 15, 2025

    Report

    Report Number
    23051238
    Event Type
    Malfunction
    Date Received
    September 15, 2025
    Date of Event
    April 16, 2025
    Report Date
    August 7, 2025
    Manufacturer
    BOEKEL SCIENTIFIC.
    Product Code
    KSQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    BLOOD SCALE W/ [WITH] SERIAL NUMBER [REDACTED], BIO MED NUMBER 10001773 USED FOR TP [TRANSFUSION PROTOCOL]. CALIBRATED AND TARED PER PROTOCOL. AS BLOOD STARTED TO FLOW EVERYTHING APPEARED NORMAL UNTIL BAG SEEMED TO LOOK LIKE IT WAS CLOSE TO 500 BUT SCALE WAS READING 340ML. CALLED OVER RN [REDACTED] TO GET HER OPINION. GRABBED SECOND SCALE TO CHECK IF WEIGHT WAS THE SAME AT THIS POINT THE FIRST SCALE WAS READING 425ML. PAUSED SCALE AND PLACED BAG ON SECOND SCALE WHICH READ 660ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2519136 BOEKEL BLOOD COLLECTION MIXER DEVICE, BLOOD MIXING AND BLOOD WEIGHING KSQ BOEKEL SCIENTIFIC. 302000

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown