BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECMO MACHINE

    MDR report key: 5636740 · Received May 4, 2016

    Report

    Report Number
    MW5062127
    Event Type
    Injury
    Date Received
    May 4, 2016
    Date of Event
    April 7, 2016
    Report Date
    May 4, 2016
    Manufacturer
    IFM ELECTRONIC
    Product Code
    DTQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT HAD BEEN CANNULATED IN THE RIGHT INTERNAL JUGULAR FOR VV ECMO APPROXIMATELY 30 MINUTES PRIOR, WHEN THE ECMO BEGAN TO ALARM. THE BEDSIDE RN NOTES THE ECMO READ 0/1PM FLOW AND 0 RPM WHEN IT BEGAN ALARMING. DURING THIS TIME, THE PT'S SYSTOLIC BP BEGAN DROPPING TO 40-50S. AS A RESULT, THE PT RECEIVED EPINEPHRINE IV. THE ECMO CIRCUIT WAS EXCHANGED. THE PT NEVER LOST A PULSE AND HAD TO BE STABILIZED WITH EPINEPHRINE AND VASOPRESSIN WHILE EQUIPMENT ISSUE WAS ADDRESSED/CORRECTED. PT SURVIVED THIS EVENT. THE ECMO MACHINE WAS TESTED FOLLOWING THIS EVENT BY THE MANUFACTURER FOLLOWED BY (B)(6) PROFESSIONALS. THE RESULTS OF TESTING, AS REPORTED BY THE MANUFACTURER'S REPRESENTATIVE WERE: "CUSTOMER HAD REPORTED EVENT HAD TAKEN PLACE (B)(6) 2016 AT AROUND 1630. SERVICE ARRIVED ON SITE AND OBTAINED LOG FILES AND PROVIDED TO CLINICAL REP. PERFORMED FUNCTIONAL AND SAFETY TESTING TO FACTORY SPECIFICATION. ALL TESTS OK." BECAUSE OF THIS, IT IS FELT THAT THE CONSUMABLES MAY HAVE BEEN AN ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    286914 ECMO MACHINE HLS MODULE ADVANCED 7.0 DTQ IFM ELECTRONIC HLS MODULE ADV ANCED 7.0 12643
    286915 ECMO CONSUMABLES HLS MODULE ADVANCED 7.0 DTQ MAQUET HLS MODULE ADVANCED 7.0 70102278

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Life Threatening| R