BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SX OXYGENATOR W/HR (STERILE)

    MDR report key: 4047003 · Received August 26, 2014

    Report

    Report Number
    1124841-2014-00130
    Event Type
    Malfunction
    Date Received
    August 26, 2014
    Date of Event
    August 8, 2014
    Report Date
    August 8, 2014
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTZ
    PMA / PMN Number
    K130359
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    TERUMO HAS NOT RECEIVED THE ACTUAL DEVICE FOR EVAL; THEREFORE, THE INVESTIGATION HAS YET TO BE COMPLETED. TERUMO PLANS ON SUBMITTING A FOLLOW-UP REPORT WHEN THE INVESTIGATION IS COMPLETE AND MORE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR SYSTEMS CORP. THAT OUT OF BOX, THE BLUE STOP COCK LUER WAS BROKEN OFF. NO PT INVOLVEMENT AS THIS OCCURRED OUT OF BOX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518414 SX OXYGENATOR W/HR (STERILE) BLOOD GAS OXYGENATOR DTZ TERUMO CARDIOVASCULAR SYSTEMS CORP. 3CXSX18R RF12

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK