BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMBU ACTION BLOCK PUMP

    MDR report key: 6995778 · Received November 2, 2017

    Report

    Report Number
    MW5073082
    Event Type
    Injury
    Date Received
    November 2, 2017
    Date of Event
    October 26, 2017
    Report Date
    October 31, 2017
    Manufacturer
    AMBU INC.
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    UT, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PROBLEM WITH AMBU ACTION BLOCK DEVICE. THERE WERE TWO DEVICES THAT EMPTIED IN ABOUT 48 HOURS AND SHOULD HAVE LASTED AT LEAST 70 HOURS. THE LOT FOR THE TWO DEVICES IS 19471805. ONE BAG WAS FILLED TO 550ML AND THE FLOW RATE WAS LOOKED AT 7ML/HR AND THE OTHER BAG WAS FILLED TO 375ML AND SET TO 5ML/HR. THE PT WAS ALWAYS INPATIENT AND WE HAD TO CHANGE PRODUCTS BEFORE SHE WENT HOME. LET ME KNOW WHAT OTHER INFO YOU NEED FROM ME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777426 AMBU ACTION BLOCK PUMP PUMP, INFUSION, ELASTOMERIC MEB AMBU INC. 19471805
    777427 AMBU ACTION BLOCK PUMP PUMP, INFUSION, ELASTOMERIC MEB AMBU INC. 19471805

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention