BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARDIOHELP

    MDR report key: 5284913 · Received December 10, 2015

    Report

    Report Number
    5284913
    Event Type
    Death
    Date Received
    December 10, 2015
    Date of Event
    July 12, 2015
    Report Date
    November 13, 2015
    Manufacturer
    MAQUET, INC
    Product Code
    DTQ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    WV, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD SUCCESSFUL COMPLETION OF SURGICAL REPAIR OF COMPLETE ATRIOVENTRICULAR CANAL DEFECT. TWO DAYS POST-OP, PATIENT ASPIRATED, AND ECMO WAS REQUIRED FOR RECOVERY. AFTER 72 HOURS, CLINICIANS NOTED A GRADUALLY INCREASING OUTFLOW PRESSURE WITHIN THE PATIENT'S ECMO CIRCUIT. THERE WAS NO TRANSMEMBRANE GRADIENT NOTED. NO CLOTS COULD BE SEEN BY VISUAL/FLASHLIGHT INSPECTION. IN THE 76TH HOUR OF SUPPORT THERE WAS SUDDEN CESSATION OF FLOW. FLOW COULD NOT BE RESUMED, A CLOT WAS SUSPECTED AND THE CIRCUIT CHANGED OUT. DURING REPLACEMENT OF THE CIRCUIT, THE CANNULA BECAME DISLODGED AND THE PATIENT EXSANGUINATED DURING CARDIAC COMPRESSIONS. THE PATIENT WAS RECANNULATED AND ECMO THERAPY WAS RESUMED USING THE NEW CIRCUIT. THE PATIENT EXPIRED ON (B)(6) 2015 AS CARE WAS WITHDRAWN DUE TO HER NEUROLOGICAL STATUS. MANUFACTURER RESPONSE FOR HEART-LUNG SYSTEM, CARDIOHELP (PER SITE REPORTER): MANUFACTURER INSPECTED THE DEVICE SOMETIME AFTER IT WAS RETURNED TO THEM ON 17 JULY 2015. (DEVICE WAS A LOANER UNIT PROVIDED BY MFR WHILE OUR OWN UNIT WAS SENT FOR REPAIR.) MFR CONFIRMED FROM A REVIEW OF THE DEVICE LOGS THAT IT WAS THE ONE INVOLVED IN OUR INCIDENT. MANUFACTURER RESPONSE FOR PATIENT CIRCUIT, CARDIOHELP (PER SITE REPORTER): PATIENT CIRCUIT WAS DISCARDED BEFORE MANUFACTURER'S AGENT COULD EXAMINE IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    816161 CARDIOHELP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ MAQUET, INC CARDIOHELP

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR Death| H| L| R