BEUDAMED
    FDA Adverse Event Summary report: N

    CARDIOVASCULAR PROCEDURE KIT

    MDR report key: 2000447 · Received February 14, 2011

    Report

    Report Number
    1124841-2011-00043
    Date Received
    February 14, 2011
    Date of Event
    January 28, 2011
    Report Date
    January 31, 2011
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Product Code
    DTZ
    PMA / PMN Number
    K062381
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TERUMO HAS RECEIVED THE ACTUAL DEVICE FOR EVALUATION; HOWEVER, THE INVESTIGATION HAS NOT BEEN COMPLETED. TERUMO WILL BE SUBMITTING A FOLLOW-UP REPORT WHEN MORE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR SYSTEMS THAT PRIOR TO CARDIOPULMONARY BYPASS SURGERY, OUT OF BOX, THEY RECEIVED THE INCORRECT OXYGENATOR WITHIN THEIR BUNDLED CARDIOVASCULAR PROCEDURE KIT. THERE WAS NO PT INVOLVEMENT AS THIS OCCURRED OUT OF BOX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDIOVASCULAR PROCEDURE KIT CARDIOVASCULAR PROCEDURE KIT DTZ TERUMO CARDIOVASCULAR SYSTEMS CORPORATION NA MM18

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK