BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIGGER BETTER BLADDER

    MDR report key: 5750582 · Received June 27, 2016

    Report

    Report Number
    5750582
    Event Type
    Malfunction
    Date Received
    June 27, 2016
    Date of Event
    May 15, 2016
    Report Date
    June 15, 2016
    Manufacturer
    CIRCULATORY TECHNOLOGY INC.
    Product Code
    DTN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PUMP BEGAN ALARMING WITH AN ACUTE HIGH NEGATIVE BLADDER PRESSURE OF >-100 AND PUMP WAS ALARMING. IT WAS NOTED THE BETTER BLADDER WAS SUCKED INTO ITSELF WITH VERY LITTLE BLOOD IN IT. A 1.1L VOLUME WAS GIVEN TO THE PT AND BLADDER REMAINED CONCAVE. AIR WAS ASPIRATED FROM THE HARD SHELL CASE THAT ENCASES THE BLADDER IN AN ATTEMPT TO EXPAND IT. IT TOOK APPROXIMATELY 240ML OF AIR ASPIRATION TO GET THE BLADDER TO OPEN UP. THERE WAS NO AIR IN THE ACTUAL CIRCUIT. PUMP BEGAN RUNNING AT A HIGHER FLOW BUT BLADDER CONTINUED TO COLLAPSE MULTIPLE TIMES. IT WAS LATER DETERMINED THERE WAS A CRACK IN THE HARD SHELL THAT WAS ALLOWING AIR TO BE SUCKED IN AROUND THE BLADDER. THE LEAK WAS IN A SEAM BACK TO THE INTER CHAMBER AND OUTER HOUSING. THIS CAUSED THE BLADDER TO COLLAPSE. MANUFACTURER RESPONSE FOR ECMO BLADDER, BIGGER BETTER BLADDER (PER SITE REPORTER): THE MANUFACTURER IS IN TOUCH WITH A MEMBER OF THE FDA AND HOSPITAL STAFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406383 BIGGER BETTER BLADDER RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS DTN CIRCULATORY TECHNOLOGY INC. BBB38 014603

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR NO