BEUDAMED
    FDA Adverse Event Summary report: N

    CENTRIMAG

    MDR report key: 1080712 · Received July 24, 2008

    Report

    Report Number
    1226752-2008-00001
    Date Received
    July 24, 2008
    Date of Event
    December 13, 2007
    Report Date
    July 21, 2008
    Manufacturer
    LEVITRONIX GMBH
    Product Code
    DWA
    Report Source
    Distributor report
    Reporter Location
    AR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THIS EVENT OCCURRED IN ANOTHER COUNTRY 24 HRS AFTER CENTRIMAG PLACEMENT. THE CENTRIMAG SYSTEM WAS USED FOR BIVENTRICULAR SUPPORT OF A MALE PT. THE RVAD CENTRIMAG WAS RUNNING AT 4.7 LPM AND LVAD CENTRIMAG AT 5.8 LPM. PT WAS IN THE OPERATING ROOM FOR A RE-EXPLORATION SURGERY DUE TO BLEEDING. A PERFUSIONIST REPORTED THE RVAD CONSOLE ALARMED AND DISPLAYED AN ERROR MESSAGE "MOTOR FAIL" FOLLOWED BY STOPPAGE OF THE PUMP. THE CENTRIMAG CONSOLE WAS ON AC POWER. THE PERFUSIONIST DECREASED LVAD FLOW TO 4.2 LPM UNTIL THE RVAD MOTOR WAS EXCHANGED. WHEN THE RVAD MOTOR WAS EXCHANGED, CENTRIMAG SUPPORT WAS INITIATED WITHOUT FURTHER ALARMS. THE PT EXPIRED IN 2007 OF OTHER CAUSES AFTER THREE DAYS OF SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CENTRIMAG CENTRIMAG MOTOR DWA LEVITRONIX GMBH * *

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR VALLEYLAB FORCE FX-C (AN ELECTROCAUTERY DEVICE)