BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 1941705 · Received December 20, 2010

    Report

    Report Number
    1828100-2010-02642
    Event Type
    Malfunction
    Date Received
    December 20, 2010
    Date of Event
    November 30, 2010
    Report Date
    December 20, 2010
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING PREPARATION FOR USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE USER REPORTED AN ERROR MESSAGE "SYSTEM COMPUTER ERROR, LOGGING IN PROGRESS" WAS DISPLAYED ON THE CENTRAL CONTROL MONITOR, THEN THE SCREEN WENT BLANK. THE USER ATTEMPTED TO TURN THE DEVICE OFF AND ON AGAIN, BUT THE SCREEN REMAINED BLANK. THE SURGERY CONTINUED WITHOUT THE USE OF THE MONITOR. THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO A PT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO ADVANCED PERFUSION SYSTEM 1 CENTRAL CONTROL MONITOR DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 816300

    Patients

    Seq Age Sex Outcome Treatment
    1