BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 1033269 · Received April 4, 2008

    Report

    Report Number
    1033269
    Event Type
    Malfunction
    Date Received
    April 4, 2008
    Date of Event
    March 6, 2008
    Report Date
    April 4, 2008
    Manufacturer
    MEDTRONIC CARDIAC SURGICAL PRODUCTS DIVISION
    Product Code
    DTQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A PIECE OF HAIR WAS FOUND WITHIN THE DEVICE WHEN WASHING OUT THE BYPASS CIRCUIT. THE HAIR COULD ONLY HAVE GOTTEN IN AT THE TIME OF ASSEMBLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * CARDIOPULMONARY BYPASS SYSTEM DTQ MEDTRONIC CARDIAC SURGICAL PRODUCTS DIVISION * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * NO OTHER THERAPIES| NO OTHER THERAPIES