BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACROBAT-I POSITIONER

    MDR report key: 4195965 · Received October 21, 2014

    Report

    Report Number
    2242352-2014-01130
    Event Type
    Injury
    Date Received
    October 21, 2014
    Date of Event
    November 25, 2013
    Report Date
    September 25, 2014
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    DWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THE DEVICE IS NOT AVAILABLE TO BE RETURNED TO US, A TECHNICAL EVALUATION CANNOT BE PERFORMED. PER OUR STANDARDS SOP'S, ALL EVENTS ARE TRACKED AND TRENDED TO DETERMINE WHETHER OR NOT ANY TRENDS DEVELOP. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT WHILE USING ACROBAT-I POSITIONER, IN ALMOST ALL CASES, THEY HAVE NOTICED THAT THE DEVICE CAUSES A EPICARDIAL HEMATOMA WHILE USING 200 MMHG PRESSURE. THE SURGEON EXPERIENCED SIMILAR HEMATOMAS IN A COUPLE OF SURGERIES AND PRESSED IT WITH GAUZE AND THERE WAS NO ADVERSE CONSEQUENCES. HOWEVER THE SURGEON IS WORRIED ABOUT USING THE POSITIONER IN VERY SICK PATIENTS WITH A TENDER MYOCARDIUM BECAUSE OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670262 ACROBAT-I POSITIONER CLAMP-LESS BEATING HEART DWS MAQUET CARDIOVASCULAR, LLC XP-5000

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other