BEUDAMED
    FDA Adverse Event Death Summary report: N

    MAQUET CARDIOHELP

    MDR report key: 4113768 · Received September 3, 2014

    Report

    Report Number
    8010762-2014-00324
    Event Type
    Death
    Date Received
    September 3, 2014
    Date of Event
    July 31, 2014
    Report Date
    August 5, 2014
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTQ
    PMA / PMN Number
    K102726
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MAQUET PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT. A MAQUET SERVICE TECHNICIAN EXPLAINED VIA PHONE CALL WITH A NURSE, AN ENGINEER, AND THE FLIGHT NURSE, THAT IF THEY TURNED OFF THE GAS FLOW, THEN THE OXYGENATOR WOULD NOT RECEIVE ANY GAS AND IT WOULDN'T MATTER WHAT THE FIO2 SETTING WAS, THERE WAS NO GAS FLOW TO ALLOW ANY VENTILATION TO THE OXYGENATOR. AFTER THIS CONVERSATION THEY SEEMED TO UNDERSTAND THAT THE EVENT WAS RELATED TO HOW A BLENDER WORKS AND NOT THE CARDIOHELP FUNCTION. THE CARDIOHELP DEVICE HAS BEEN REQUESTED FOR RETURN TO PERFORM EVAL. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED IF ADDITIONAL INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    ORIGINALLY IT WAS REPORTED THAT NO ERROR ON A CARDIOHELP WAS NOTICED WHILE TRANSPORTING A PT. THEN IT WAS REPORTED THAT WHILE TRANSPORTING A PT ON A PLANE, THERE WAS A NO FLOW SITUATION REGARDING A SECHRIST AIR OXYGEN MIXER (BLENDER) BEING USED IN CONJUNCTION WITH A CARDIOHELP DEVICE. ONE OF THE TWO AIR SUPPLY PUMPS QUIT WORKING AND THE BLENDER BLEED-OFF ALARM ACTIVATED. SOMEONE THEN SELECTED 100% FIO2 WHILE THEY SHUT OFF THE BLENDER FLOW METER. IT WAS THEN NOTED THAT THE BLOOD GOT DARK AND THE PT CODED. ADDITIONAL INFO PROVIDED ON (B)(6) 2014 - DURING PT TRANSPORT THE BUBBLE SENSOR CLAMP POPPED OPEN AND THE RPM INDICATOR PORTION OF THE SCREEN BLINKED ON AND OFF. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    536664 MAQUET CARDIOHELP CARDIOHELP DTQ MAQUET CARDIOPULMONARY AG 70104.8012

    Patients

    Seq Age Sex Outcome Treatment
    1 Death