BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROFILE 8 FR. 34 CC IAB WITH ACCESSORIES. INTERNATIONAL

    MDR report key: 326697 · Received April 13, 2001

    Report

    Report Number
    2248146-2001-00009
    Event Type
    Death
    Date Received
    April 13, 2001
    Date of Event
    March 8, 2001
    Report Date
    April 3, 2001
    Manufacturer
    DATASCOPE CORPORATION
    Product Code
    DSP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE 8 FR IAB WAS INSERTED INTO THE PT IN 2001. THE NEXT DAY AFTER IABP WAS IMPLANTED FOR 24 HOURS, AN ALARM SOUNDED FROM THE SYSTEM 97 PUMP AND BLOOD WAS NOTED IN THE CATHETER TUBING. THE IAB WAS REMOVED AND NO SECOND IAB WAS INSERTED. EVENT COMPLICATIONS: THE PT EXPIRED - REPORTED 4/3/01. PT'S CURRENT STATUS: EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17137 PROFILE 8 FR. 34 CC IAB WITH ACCESSORIES. INTERNATIONAL INTRA-AORTIC BALLOON CATHETER DSP DATASCOPE CORPORATION 0884-00-0008 4/21/02

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death