BEUDAMED
    FDA Adverse Event Death Summary report: N

    MAQUET CARDIOPULMONARY AG

    MDR report key: 3983084 · Received July 1, 2014

    Report

    Report Number
    8010762-2014-00252
    Event Type
    Death
    Date Received
    July 1, 2014
    Date of Event
    May 30, 2014
    Report Date
    June 1, 2014
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    KFM
    PMA / PMN Number
    K991864
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A MAQUET SERVICE TECHNICIAN EVALUATED THE DEVICE AND COULD NOT DUPLICATE THE REPORTED ISSUE. THE TECHNICIAN VERIFIED THE FLOW SENSOR WAS READING CORRECTLY AND THE BATTERY CHARGE FUNCTION WAS OPERATING ACCORDING TO SPECIFICATION. A COMPLETE PERFORMANCE, FUNCTION AND PREVENTIVE MAINTENANCE INSPECTION WAS PERFORMED. THE DEVICE WAS FOUND TO BE OPERATING ACCORDING TO SPECIFICATION. (B)(4). A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED IF ADD'L INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LPM DISPLAY ON THE DEVICE WAS INTERMITTENTLY INDICATING DASHED LINES. PERFUSION STAFF REAPPLIED ULTRASONIC PASTE TO THE FLOW SENSOR AND THE ISSUE REMAINED. THE PATIENT'S BIS WENT TO ZERO, PUPILS WERE BLOWN AND DILATED. IT WAS SUSPECTED THE PATIENT HAD STROKED- A CT SCAN WAS BEING CONSIDERED. THE CIRCUIT WAS EXAMINED TO DETERMINE THE CAUSE OF THE CONSOLE HAVING PROBLEMS. IT WAS NOTED THE BATTERY CHARGING LIGHT WAS NOT ILLUMINATED SO A CONSOLE CHANGE WAS DECIDED. UPON RETURNING 5 MINUTES LATER WITH ANOTHER CONSOLE, IT WAS NOTED THE VENOUS LINE WAS FULL OF AIR DOWN TO THE OXYGENATOR. THE CIRCUIT WAS REPLACED TO RESOLVE THE AIR ISSUE. THERE WERE NO OTHER AIR ISSUES SINCE THE CIRCUIT WAS CHANGED. THE PATIENT EXPIRED BUT CAUSE OF DEATH IS NOT KNOWN. THERE IS NO INDICATION AT THIS TIME THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385590 MAQUET CARDIOPULMONARY AG ROTAFLOW CONSOLE KFM MAQUET CARDIOPULMONARY AG 70105.1712

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Death| O