BEUDAMED
    FDA Adverse Event Death Summary report: N

    KRONNER MEDICAL

    MDR report key: 6233887 · Received January 9, 2017

    Report

    Report Number
    6233887
    Event Type
    Death
    Date Received
    January 9, 2017
    Date of Event
    December 30, 2016
    Report Date
    January 5, 2017
    Manufacturer
    KRONNER MEDICAL
    Product Code
    LKF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    (B)(6) WAS A (B)(6) FEMALE WHO UNDERWENT AN ELECTIVE ROBOTIC HYSTERECTOMY ON (B)(6) 2016. INTRAOPERATIVELY, THE PT HAD A MASSIVE NITROGEN AIR EMBOLISM TO THE HEART. (B)(6) HAD A CARDIAC ARREST AND CPR/ACLS PROTOCOL INITIATED. DESPITE HEROIC MEASURES TAKEN TO REMOVE THE AIR. (B)(6) WAS DECLARED BRAIN DEAD ON (B)(6) 2017 LIFE SUPPORT WAS WITHDRAWN AND PT EXPIRED AT 1633 ON (B)(6) 2017. JUST PRIOR TO STARTING THE ROBOTIC HYSTERECTOMY, IT WAS NOTED THAT AFTER THE VCARE UTERINE MANIPULATOR WAS PLACED AND THE NITROGEN GAS WAS TURNED ON TO THE KRONNER SIDE-KICK, A HISSING SOUND WAS HEARD AND IT WAS NOTED THAT THE TUBING WAS IMPROPERLY CONNECTED. THE GAS WAS IMMEDIATELY TURNED OFF WITHIN SECONDS. THE TUBING THAT SHOULD HAVE BEEN CONNECTED TO THE PORT FOR THE KRONNER SIDE-KICK HAD BEEN CONNECTED TO THE CHROMOTUBATION PORT TO THE VCARE UTERINE MANIPULATOR INSTEAD. THERE WAS NO WARNING LABEL ON ALERT TO DISTINGUISH THE TWO PORTS. THE TUBING INTENDED FOR THE KRONNER SIDE-KICK ALSO FIT THE PORT TO THE VCARE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17325 KRONNER MEDICAL KRONNER SIDE-KICK LKF KRONNER MEDICAL KRONNER 5000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Death KRONNER MEDICAL TUBING: LOT #H1030188, | LOT #201303091, REF #60-6085-202, EXP: 03/09/2018| REF # H08-03059, EXP: 09/30/2019| VCARE UTERINE MANIPULATOR: SIZE MEDIUM,