BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DATASCOPE CORPORATION

    MDR report key: 378613 · Received February 21, 2002

    Report

    Report Number
    MW1024141
    Event Type
    Injury
    Date Received
    February 21, 2002
    Date of Event
    January 28, 2002
    Report Date
    January 28, 2002
    Manufacturer
    DATASCOPE CORPORATION
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    INTRA-AORTIC BALLOON CATHETER WAS PLACED DUE TO CARDIOGENIC SHOCK. APPROX 5.5 HRS LATER, BLOOD "FLAKES" WERE NOTED TO BE PRESENT IN THE EXTRACORPOREAL TUBING, INDICATIVE OF A LEAKING BALLOON. THE IAB CONSOLE WAS ALARMING "SLOW GAS LOSS" AT THE TIME. THE PHYSICIAN WAS NOTIFIED OF THE EVENT, IAB CONSOLE PLACED ON "STANDBY" AT HIS REQUEST, AND THE IAB CATHETER WAS REPLACED ABOUT ONE HOUR LATER. THERE WERE NO NEGATIVE OUTCOMES IN PT STATUS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DATASCOPE CORPORATION INTRA-AORTIC BALLOON CATHETER DSP DATASCOPE CORPORATION PROFILE 8.0 FR. 34CC *

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention