BEUDAMED
    FDA Adverse Event Death Summary report: N

    SENSATION 7FR 34CC IAB

    MDR report key: 5742650 · Received June 22, 2016

    Report

    Report Number
    2248146-2016-00052
    Event Type
    Death
    Date Received
    June 22, 2016
    Date of Event
    May 27, 2016
    Report Date
    January 30, 2018
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    PMA / PMN Number
    K041281
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2016 06:05 PM (GMT-4:00) ADDED BY (B)(6) (B)(4): THE IAB WAS NOT RETURNED AND SO IT COULD NOT BE EVALUATED. A SHIP HISTORY REVIEW AND TREND EVALUATION WAS COMPLETED FOR THE REPORTED PRODUCT. NO NONCONFORMANCES WERE FOUND THAT ARE CONSIDERED TO BE RELATED TO THE EVENT. EVALUATION OF DEVICE COULD NOT BE PERFORMED SINCE IT WAS NOT RETURNED. NO ROOT CAUSE COULD BE IDENTIFIED FOR FIR/CAPA EVALUATION. THE COMPLAINT COULD NOT BE CONFIRMED.

    Additional Manufacturer Narrative · 1

    CORRECTION: DATE WAS NOT ENTERED IN THE INITIAL MDR. DATE: (B)(6) 2016

    Description of Event or Problem · 1

    THE BALLOON CATHETER WAS INSERTED WHILE ATTACHED TO THE BALLOON PUMP, EVERYTHING APPEARED TO BE OKAY. THE PATIENT'S ANATOMY WAS TORTUOUS AND A LONGER THAN NORMAL SHEATH WAS NECESSARY. THE AUGMENTATION WAS INITIALLY OK BUT THEN IT APPEARED LOW. IT WAS DETERMINED THAT THERE WAS A PROBLEM WITH THE PRESSURE BAG, IT WAS CHANGED OUT AND THEN THE AUGMENTATION APPEARED TO BE OKAY AGAIN. AFTER ABOUT 15 MINUTES THE PUMP STOPPED AND ALARMED, "CHECK IAB CATHETER." THE CLINICIANS CHECKED ALL CONNECTIONS, CHECKED FOR BLOOD IN THE TUBING, CHECKED THE POSITION OF THE CATHETER, AND EVEN ASKED THE MD TO ENSURE THAT THE CATHETER WAS PROPERLY POSITIONED. THE PATIENT'S CONDITION STARTED TO DETERIORATE DURING THIS TIME. THE CLINICIANS DOUBLE CHECKED EVERYTHING IN THE HELP MENU ON THE BALLOON PUMP AND ATTEMPTED TO RESTART THE PUMP AND RECEIVED ANOTHER MESSAGE, "CHECK IAB CATHETER." THE CHECK IAB CATHETER ALARM COULD NOT BE RESOLVED AND THE DECISION WAS MADE TO PUT THE PATIENT ON THE IMPELLA RATHER THAN ANOTHER IAB/PUMP. THE PATIENT WAS CODING WHEN THEY FIRST HAD HIM ON THE IMPELLA BUT THEN AFTER AN HOUR HE DIED AND THE IAB WAS DISCARDED.

    Description of Event or Problem · 1

    THE BALLOON CATHETER WAS INSERTED WHILE ATTACHED TO THE BALLOON PUMP, EVERYTHING APPEARED TO BE OKAY. THE PATIENT'S ANATOMY WAS TORTUOUS AND A LONGER THAN NORMAL SHEATH WAS NECESSARY. THE AUGMENTATION WAS INITIALLY OK BUT THEN IT APPEARED LOW. IT WAS DETERMINED THAT THERE WAS A PROBLEM WITH THE PRESSURE BAG, IT WAS CHANGED OUT AND THEN THE AUGMENTATION APPEARED TO BE OKAY AGAIN. AFTER ABOUT 15 MINUTES THE PUMP STOPPED AND ALARMED, "CHECK IAB CATHETER." THE CLINICIANS CHECKED ALL CONNECTIONS, CHECKED FOR BLOOD IN THE TUBING, CHECKED THE POSITION OF THE CATHETER, AND EVEN ASKED THE MD TO ENSURE THAT THE CATHETER WAS PROPERLY POSITIONED. THE PATIENT'S CONDITION STARTED TO DETERIORATE DURING THIS TIME. THE CLINICIANS DOUBLE CHECKED EVERYTHING IN THE HELP MENU ON THE BALLOON PUMP AND ATTEMPTED TO RESTART THE PUMP AND RECEIVED ANOTHER MESSAGE, "CHECK IAB CATHETER." THE ¿CHECK IAB CATHETER¿ ALARM COULD NOT BE RESOLVED AND THE DECISION WAS MADE TO PUT THE PATIENT ON THE IMPELLA RATHER THAN ANOTHER IAB/PUMP. THE PATIENT WAS CODING WHEN THEY FIRST HAD HIM ON THE IMPELLA BUT THEN AFTER AN HOUR HE DIED AND THE IAB WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396378 SENSATION 7FR 34CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Death