BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYSTEM 98

    MDR report key: 6425915 · Received March 22, 2017

    Report

    Report Number
    2249723-2017-00008
    Event Type
    Death
    Date Received
    March 22, 2017
    Date of Event
    January 21, 2017
    Report Date
    March 7, 2017
    Manufacturer
    DATASCOPE MAHWAH
    Product Code
    DSP
    PMA / PMN Number
    K961509
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION. IT WAS LATER REPORTED BY THE COMPANY REPRESENTATIVE THAT THE CUSTOMER REPLACED THE FILTER 0008-00-0331 ON (B)(6) 2017 DUE TO BLOOD CONTAMINATION PRIOR TO MAQUET BECOMING AWARE OF THE EVENT ON FEBRUARY 22, 2017. THE PRODUCTION DEVICE HISTORY RECORD (DHR) FOR THIS IABP UNIT WAS REVIEWED AND NO NON-CONFORMANCES RELATED TO THE REPORTED EVENT WERE NOTED. A COMPANY REPRESENTATIVE EVALUATED THE UNIT AND REPLACED THE FILTER (PART NUMBER 0008-00-0331) DUE TO BLOOD CONTAMINATION. THE COMPANY REPRESENTATIVE REPORTED THAT THE UNIT WORKED NORMALLY AT THE TIME OF THE EVENT AND THERE WAS NO MALFUNCTION. THIS EVENT IS NOT INDICATIVE OF A FAILURE OR MALFUNCTION OF THE PUMP BUT SINCE A MAQUET BALLOON WAS INVOLVED AND MALFUNCTIONED AND THE PATIENT DIED WE ARE REPORTING THIS EVENT.

    Description of Event or Problem · 1

    OUR BUSINESS UNIT IN (B)(4) REPORTED THAT AN IAB WAS INSERTED ON (B)(6) 2017 BECAUSE THE PATIENT WAS AMI. THE UNIT WORKED NORMALLY UNTIL (B)(6) 2017 WHEN THE PUMP ALARMED "BLOOD DETECTED" AND BLOOD WAS FOUND IN THE TUBING. THE CUSTOMER REMOVED THE BALLOON AND BECAUSE THE PATIENT WAS OK AT THAT TIME THE DOCTOR NOT INSERT A SECOND BALLOON. A DAY LATER THE PATIENT DIED. THE PATIENT'S DEATH IS NOT ATTRIBUTED TO THE DEVICE. FURTHERMORE, AN ADDITIONAL REPORT IS BEING SUBMITTED WITH THE INFORMATION REGARDING THE INTRA-AORTIC BALLOON ((B)(4)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208300 SYSTEM 98 SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE MAHWAH 0998-00-0446-53

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death LINEAR 7.5FR 40CC IAB