BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYO CARDIOPLEGIA DELIVERY TUBE SETS

    MDR report key: 1890681 · Received November 1, 2010

    Report

    Report Number
    1124841-2010-00193
    Event Type
    Malfunction
    Date Received
    November 1, 2010
    Date of Event
    September 25, 2010
    Report Date
    October 12, 2010
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Product Code
    DTR
    PMA / PMN Number
    K823451
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TERUMO HAS NOT RECEIVED THE ACTUAL DEVICE FOR EVAL, THUS, TERUMO PLANS ON 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 THAT PRIOR TO CARDIOPULMONARY BYPASS SURGERY, OUT OF BOX, THE MP4 VENT PORT WAS OCCLUDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYO CARDIOPLEGIA DELIVERY TUBE SETS CARDIOPLEGIA DELIVERY SYSTEM DTR TERUMO CARDIOVASCULAR SYSTEMS CORPORATION 165720 MC22

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK