BEUDAMED
    FDA Adverse Event Death Summary report: N

    CS100

    MDR report key: 3141783 · Received May 30, 2013

    Report

    Report Number
    2249723-2013-00036
    Event Type
    Death
    Date Received
    May 30, 2013
    Date of Event
    April 25, 2013
    Report Date
    April 25, 2013
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    PMA / PMN Number
    K031636
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP OBSERVED THAT THE FILL TUBING, WHICH IS EXTERNAL TO THE DEVICE, WAS STRETCHED AND HAD BEEN CUT INTO TWO PIECES, CAUSING THE INABILITY TO AUTOFILL. WHILE WE CANNOT CONCLUSIVELY DETERMINE HOW THE FILL TUBING WAS STRETCHED AND BROKEN, THIS TYPE OF PHYSICAL DAMAGE IS CONSISTENT WITH THE TUBING HAVING BEEN CAUGHT ON SOMETHING WHILE THE IABP WAS BEING MOVED. THE COMPANY REP REPAIRED THE FILL TUBING. THE IABP WAS TESTED TO FACTORY SPEC. IT FUNCTIONED NORMALLY AND WAS RETURNED TO THE CUSTOMER. ADDITIONAL INFO HAS BEEN REQUESTED. A SUPPLEMENTAL MEDWATCH FORM WILL BE FILED WHEN OUR INVESTIGATION IS COMPLETED. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT PRIOR TO USE ON A CRITICALLY ILL PT, THE IABP GENERATED AN AUTOFILL FAILURE ALARM. THEY WERE UNABLE TO INITIATE THERAPY. THE PT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238407 CS100 INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP. CS100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Death