BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARDIOHELP SYSTEM

    MDR report key: 6637009 · Received June 13, 2017

    Report

    Report Number
    8010762-2017-00192
    Event Type
    Death
    Date Received
    June 13, 2017
    Date of Event
    June 6, 2017
    Report Date
    October 16, 2017
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTQ
    PMA / PMN Number
    K102726
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    ON 07/06/2017: IT WAS REPORTED THAT THE PATIENT WAS STABLE AFTER THE REPORTED INCIDENT ON DAY 25 (AND A SIMILAR BRIEF INCIDENT ON DAY 9) OF THE ECLS RUN. IT WAS ALSO REPORTED THAT THE PATIENT¿S LUNGS NEVER SHOWED SIGNS OF RECOVERY AND SHE DIED AFTER 52 DAYS ON ECLS.

    Additional Manufacturer Narrative · 1

    SINCE THE WHOLE DEVICE HAS BEEN SENT TO LIFE CYCLE ENGINEERING (LCE), IT HAS NOT BEEN REPAIRED BY A MAQUET FIELD SERVICE TECHNICIAN. THEREFORE A SERVICE REPORT DOES NOT EXIST. RESULT OF INVESTIGATION REPORT LCE 3355 AND LOG-FILES ANALYSIS: SINCE THE DEVICE RAN ON EMERGENCY MODE, THE SCREEN WAS LOCKED. THEREFORE THE CUSTOMER COULD NOT DEACTIVATE INTERVENTIONS OR TO ACTIVATE THE "GLOBAL OVERRIDE" MODE. BEFORE STARTING THE EMERGENCY MODE THE ARTERIAL BUBBLE SENSOR HAS BEEN REMOVED FROM THE DEVICE. ACCORDING TO THE LOGFILES OF THE CARDIOHELP THE DESCRIBED BEHAVIOR COULD BE RECONSTRUCTED. NO DEVICE-DEFECT COULD BE PROVEN. THE MOST PROBABLE ROOT CAUSE IS A USER ERROR.

    Description of Event or Problem · 1

    (B)(4). DURING A PATIENT TREATMENT NO FLOW ON CARDIOHELP OCCURRED AND BUBBLE DETECTOR ALARM WAS EVIDENT. STAFF ATTEMPTED TO CLEAR THE ALARM, BUT THEY COULD NOT USE THE GLOBAL OVERRIDE FUNCTION, SCREEN APPEARED FROZEN. PATIENT TRANSFERRED TO HAND CRANK. DURING TRANSFER, PATIENT SUFFERED LOSS OF CARDIAC OUTPUT. THE SUSPECT CARDIOHELP WAS REPLACED AND FLOW ESTABLISHED. ALL APPROPRIATE CHECKS CARRIED OUT. IT WAS REPORTED THAT THE PATIENT IS STABLE WHEN ON ECMO.

    Description of Event or Problem · 1

    (B)(4).

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    417328 CARDIOHELP SYSTEM CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ MAQUET CARDIOPULMONARY AG

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Life Threatening