BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROFILE 8 FR. 40 CC. IAB WITH ACCESSORIES-DOMESTIC

    MDR report key: 288661 · Received August 1, 2000

    Report

    Report Number
    2248146-2000-00009
    Event Type
    Death
    Date Received
    August 1, 2000
    Date of Event
    July 1, 2000
    Report Date
    July 5, 2000
    Manufacturer
    DATASCOPE CORPORATION
    Product Code
    DSP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE IAB WAS INSERTED INTO THE PT IN 2000. TWO DAYS LATER AFTER IABP FOR APPROX 12 HOURS, THE "LEAK IN CIRCUIT" ALARM SOUNDED FROM THE SYSTEM 97 PUMP AT 7:00 A.M. WHEN THE RN INSPECTED THE CATHETER, BLOOD SPECKS WERE VISIBLE IN THE CATHETER. THE DR WAS NOTIFIED AND PUMPING CONTINUED. MULTIPLE ALARMS SOUNDED THROUGHOUT THE DAY. (THERE WERE 10 "LEAK IN IABP CIRCUIT" ALARMS.) SEVERAL HOURS AFTER THE 1ST ALARM, THE DR ATTEMPTED TO REMOVE THE CATHETER BUT IT WAS ENTRAPPED. AT 7:00 P.M., THE PUMP WAS TURNED OFF AND THE DR ATTEMPTED AGAIN TO REMOVE THE CATHETER WITHOUT SUCCESS. THE PT WENT ON TO EXPIRE WITH THE IAB IN PLACE. IT WAS UNKNOWN IF THE DEATH WAS ATTRIBUTED TO THE EVENT. THE PT WAS BALLOON DEPENDENT AND AN ATTEMPT TO INSERT IN THE OTHER LEG WAS UNSUCCESSFUL. EVENT COMPLICATIONS: THE PT WENT ON TO EXPIRE - REPORTED 07/13/2000. PT'S CURRENT STATUS: EXPIRED - REPORTED 07/13/2000.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROFILE 8 FR. 40 CC. IAB WITH ACCESSORIES-DOMESTIC INTRA-AORTIC BALLOON CATHETER DSP DATASCOPE CORPORATION 0684-00-0297-01 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death