BEUDAMED
    FDA Adverse Event Death Summary report: N

    CUSTOM PERFUSION SYSTEM

    MDR report key: 6194142 · Received December 19, 2016

    Report

    Report Number
    MW5066830
    Event Type
    Death
    Date Received
    December 19, 2016
    Date of Event
    December 5, 2016
    Report Date
    December 19, 2016
    Manufacturer
    MEDTRONIC
    Product Code
    KFM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT WAS HEMODYNAMICALLY UNSTABLE WITH RESPIRATORY FAILURE AND REQUIRED ECMO SUPPORT. ARTERIAL AND VENOUS CANNULAS WERE INSERTED VIA LEFT GROIN AFTER HEPARINIZATION. CANNULA POSITION WAS CONFIRMED BY TEE ECMO CIRCUIT WAS BROUGHT TO SURGICAL FIELD. CIRCUIT HAS TWO ENDS, WHICH WERE LABELED RED AND BLUE BY MFR. THE RED CANNULA SHOULD CONNECT TO ARTERIAL ACCESS FOR PERFUSION, AND THE BLUE CANNULA SHOULD CONNECT TO VENOUS ACCESS FOR DRAINAGE, WHICH WAS COMPLETED. ONCE ECMO WAS INITIATED, PT WAS FOUND TO BE HYPOTENSIVE (30-40MMHG) WITH RIGHT VENTRICULAR DISTENTION. ECMO WAS NOT FLOWING SUFFICIENTLY, AND PERFUSIONIST FOUND CIRCUIT CONNECTION WAS WRONG; RED LABELED LINE WAS VENOUS, AND BLUE LABELED LINE WAS ARTERIAL. DIAGNOSIS OR REASON FOR USE: FAILED COMPLETION PNEUMONECTOMY. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    836162 CUSTOM PERFUSION SYSTEM CUSTOM PERFUSION SYSTEM KFM MEDTRONIC ADULTE 211403627

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Death