BEUDAMED
    FDA Adverse Event Death Summary report: N

    VKMO 78000 #QUADROX-I HMO 70000+VHK7000

    MDR report key: 4101385 · Received August 27, 2014

    Report

    Report Number
    8010762-2014-00334
    Event Type
    Death
    Date Received
    August 27, 2014
    Date of Event
    July 24, 2014
    Report Date
    July 28, 2014
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTQ
    PMA / PMN Number
    K102726
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED AND EVALUATED. INITIAL VISUAL INSPECTION SHOWS THE DEVICE HAD BEEN RINSED BY THE HOSPITAL, SO NO CLOTTING OR OTHER IRREGULARITIES WERE VISUALLY PRESENT. THE DEVICE WAS THEN CLEANED AND DISINFECTED WITH 5% NATRIUM HYPOCHLORITE, WITH NO CLOTS NOTED. FURTHER INVESTIGATION AND TESTING IS ONGOING. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR THE LOT. THE DEVICE PASSED THE FINAL 100% TEST, WITH NO DEVIATIONS OR ABNORMALITIES NOTED FOR THIS PRODUCTION LOT. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 30 MINUTES INTO OPEN HEART SURGERY, THE OXYGEN PA02 VALUE IN THE ARTERIAL LINE DROPPED TO 50 MMHG AND STOPPED. THE GAS SUPPLY WAS SWITCHED FORM THE WALL TO AN OXYGEN BOTTLE. NO DIFFERENCE WAS OBSERVED. THE PATIENT EXPIRED DURING THE OPERATION. ON (B)(6) 2014 THE OXYGEN SATURATION IN THE OR WAS MEASURED AS 70% BY THE HOSPITAL BIOMEDICAL ENGINEER. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    519009 VKMO 78000 #QUADROX-I HMO 70000+VHK7000 QUADROX-I DTQ MAQUET CARDIOPULMONARY AG 70097487

    Patients

    Seq Age Sex Outcome Treatment
    1 Death