BEUDAMED
    FDA Adverse Event Summary report: N

    *

    MDR report key: 1242183 · Received November 19, 2008

    Report

    Report Number
    1226752-2008-00004
    Date Received
    November 19, 2008
    Date of Event
    September 23, 2008
    Report Date
    October 30, 2008
    Manufacturer
    *
    Product Code
    KFM
    Report Source
    Distributor report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IN 2008, A PERFUSIONIST FROM HOSPITAL CONTACTED THE CENTRIMAG SYSTEM U.S. DISTRIBUTOR AND REPORTED THAT A CENTRIMAG BLOOD PUMP USED TO SUPPORT THE RIGHT HEART OF A PT TRIGGERED A "MOTOR DRIVE FAIL" ALARM. THE CENTRIMAG MOTOR WAS UNPLUGGED FROM CONSOLE 000474 AND CONNECTED TO THE BACK-UP CONSOLE. IN TURN THE BACK-UP CONSOLE THEN ALARMED. THE SPECIFIC ALARM ON THE BACKUP CONSOLE WAS NOT RECORDED. THE MOTOR AND LATER THE BLOOD PUMP WERE EXCHANGED. THE ALARM ON THE BACKUP CONSOLE WAS ACKNOWLEDGED AND SUPPORT RE-ESTABLISHED. DURING MOTOR AND PUMP EXCHANGES, IT WAS REPORTED THAT WHITE AND RED CONCENTRIC RINGS WERE SEEN IN THE BASE OF THE CENTRIMAG BLOOD PUMP. LEVITRONIX REQUESTED THAT THE SUSPECT PUMP AND MOTOR BE RETURNED FOR ANALYSIS. THE PT WAS WITHDRAWN FROM SUPPORT THE FOLLOWING MONTH, AND EXPIRED LATER THAT MORNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * CENTRIMAG BLOOD PUMP KFM * * *

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR