BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FILTER, PRE BYPASS

    MDR report key: 2494521 · Received February 27, 2012

    Report

    Report Number
    2494521
    Event Type
    Malfunction
    Date Received
    February 27, 2012
    Date of Event
    February 10, 2012
    Report Date
    February 24, 2012
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    KRJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A PRE-BYPASS FILTER USED WITH THE CARDIOPULMONARY BYPASS (CPB) CIRCUIT OCCLUDED DURING SET UP FOR AN UNKNOWN REASON. THERE WAS NO PT EXPOSURE. THE PRE-BYPASS FILTER FAILED TO OPERATE CORRECTLY. IT APPEARS TO HAVE COME FROM THE FACTORY SEALED ON THE INFLOW SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FILTER, PRE BYPASS DISPOSABLE PRODUCT (DESCRIBE BELOW) KRJ TERUMO CARDIOVASCULAR SYSTEMS CORP. PRE-BYPASS PLUS .2 MICRO FILTER NP19

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR