BEUDAMED
    FDA Adverse Event Death Summary report: N

    CS300

    MDR report key: 7362897 · Received March 22, 2018

    Report

    Report Number
    2249723-2018-00465
    Event Type
    Death
    Date Received
    March 22, 2018
    Date of Event
    February 17, 2018
    Report Date
    March 22, 2018
    Manufacturer
    DATASCOPE MAHWAH
    Product Code
    DSP
    PMA / PMN Number
    K063525
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SY
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCTION DEVICE HISTORY RECORD (DHR) FOR THIS IABP UNIT CANNOT BE REVIEWED PER THE SOP SINCE THE SERIAL NUMBER FOR THE UNIT WAS NOT PROVIDED. (B)(6). (B)(4). THE CUSTOMER HAS NOT REPORTED AN ALLEGED MALFUNCTION OF THE IABP AND THEREFORE HAS NOT REQUESTED GETINGE TO EVALUATE THE UNIT. THE DETAILS OF THE INVOLVED IABP HAVE NOT BEEN PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE CUSTOMER. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING CS300 INTRA-AORTIC BALLOON (IABP) THERAPY, SOME PROBLEMS OCCURRED DURING THE INSERTION OF TWO INTRA-AORTIC BALLOON (IAB) CATHETERS IN THE CARDIAC CENTER. THE FIRST IAB CATHETER HAD ITS AXES BROKEN AFTER COMPLETION OF THE INSERTION PROCEDURE, WHICH CAUSED INFUSION OF BLOOD INTO THE BALLOON. THE CUSTOMER HAS CONCERNS THAT THIS MAY HAVE CAUSED THE DEATH OF THE PATIENT. THE SECOND IAB CATHETER HAD ITS AXES BROKEN DURING THE INSERTION DUE TO THE SHEATH WHICH WAS TOO TIGHT TO INSERT THE CATHETER EASILY INTO IT. THE MEDICAL STAFF USED A THIRD BALLOON CATHETER WHICH WAS INSERTED CORRECTLY, AND THERAPY WAS CONTINUED. THE PATIENT DIED 8 HOURS LATER AND IT IS UNKNOWN WHETHER THE CAUSE OF DEATH WAS DUE TO THE CATHETER OR DUE TO THE CLINICAL STATUS OF THE PATIENT. THERE WAS NO ALLEGED MALFUNCTION OF THE IABP. THIS EVENT IS RELATED TO IAB REPORTS TO BE SUBMITTED UNDER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205016 CS300 SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE MAHWAH N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death LINEAR 7.5 FR. 40CC IAB