BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 1860420 · Received September 27, 2010

    Report

    Report Number
    1828100-2010-01746
    Event Type
    Malfunction
    Date Received
    September 27, 2010
    Date of Event
    June 10, 2010
    Report Date
    September 27, 2010
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION IN PROGRESS, BUT NOT YET CONCLUDED.

    Description of Event or Problem · 1

    THE USER REPORTED THAT WIRES OF THE LAMP WERE EXPOSED. A BIOMEDICAL TECHNICIAN ATTEMPTED TO REPAIR THE EXPOSED WIRES, BUT SPLICES DURING THE REPAIR CAUSED SHORTING AND INACCURATE VOLTAGE READINGS FROM THE HEART LUNG MACHINE POWER SUPPLY. THE DEVICE WAS USED FOR THE PROCEDURE. THE USER REPORTED THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO ADVANCED PERFUSION SYSTEM 1 ASSEMBLY SHORT NECK LAMP DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 801558

    Patients

    Seq Age Sex Outcome Treatment
    1