BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOMEDICUS EXTERNAL DRIVE UNIT

    MDR report key: 3911252 · Received July 2, 2014

    Report

    Report Number
    2184009-2014-00047
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Date of Event
    April 15, 2014
    Report Date
    June 26, 2014
    Manufacturer
    PERFUSION SYSTEMS
    Product Code
    DWA
    PMA / PMN Number
    K070286
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT MEDTRONIC¿S SERVICE DEPOT, ANALYSIS OF THE EXTERNAL MOTOR DRIVE DETERMINED THAT THE MOTOR SPEED INCREASED TO MAXIMUM SPEED DUE TO AN INTERMITTENT MOTOR CABLE CONNECTION IN THE EXTERNAL MOTOR DRIVE. THE PRODUCT WAS SCRAPPED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT DURING BYPASS A BIO-CONSOLE USED IN CONJUNCTION WITH THIS EXTERNAL MOTOR DRIVE DISPLAYED A MOTOR CONTROLLER MALFUNCTION ERROR AND THE RPM (REVOLUTIONS PER MINUTE) INCREASED TO THE MAXIMUM LIMIT. THE FLOW WAS CONTROLLED BY USING THE CLAMP ON THE ARTERIAL-LINE. THE USER TURNED OFF THE PUMP SPEED KNOB TO RESET THE RPMS AND THE PUMP RETURNED TO NORMAL STATUS. THE UNIT WAS THEN USED TO COMPLETE THE CASE WITH NO ADVERSE EFFECTS ON THE PATIENT. THE EXTERNAL MOTOR DRIVE IS EXPECTED TO BE RETURNED TO MEDTRONIC FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385932 BIOMEDICUS EXTERNAL DRIVE UNIT CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS DWA PERFUSION SYSTEMS 540T

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR