BEUDAMED
    FDA Adverse Event Death Summary report: N

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

    MDR report key: 292497 · Received August 25, 2000

    Report

    Report Number
    2248146-2000-00012
    Event Type
    Death
    Date Received
    August 25, 2000
    Date of Event
    July 7, 2000
    Report Date
    July 10, 2000
    Manufacturer
    DATASCOPE CORPORATION
    Product Code
    DSP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE PT WENT TO THE CATH LAB IN 2000. THE IAB WAS INSERTED WITH FLUOROSCOPY THE NEXT DAY. THE "SLOW GAS LEAK" ALARM SOUNDED FROM THE PUMP. NO BLOOD WAS NOTED AT FIRST, BUT EVENTUALLY BLOOD WAS NOTED AND THE IAB WAS REMOVED. NO SECOND IAB WAS INSERTED. ON 8/4/00, DATASCOPE REC'D THE FOLLOWING INFO: THE PT WAS ADMITTED TO THE TELEMETRY UNIT AND ON 7/5/00 WAS TRANSFERRED TO CCU DUE TO CHEST PAIN UNRELIEVED BY NITRO. DAYS LATER, AN IAB WAS INSERTED IN THE CATH LAB USING FLUORO. THE PT ARRIVED BACK IN THE UNIT WITH IABP AT 1:1. THAT SAME DAY AT 0530 THE "GAS LEAK" ALARM SOUNDED FROM THE PUMP. THE DR WAS CALLED AND A STAT ECHO WAS ORDERED. BLOOD WAS NOTED IN THE TUBING AND THE IAB WAS REMOVED AT 0700. THE PT EXPIRED THE SAME DAY BEFORE THE PT COULD BE RETURNED TO THE CATH LAB FOR REINSERTION OF ANOTHER IAB. EVENT COMPLICAITONS : EXPIRED - REPORTED 8/4/00. PT'S CURRENT STATUS: EXPIRED-REPORTED 8/4/00.

    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 0884-00-0009 4/14/02

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death