BEUDAMED
    FDA Adverse Event Summary report: N

    HOLDER FOR FX15/25 OXYGENATOR

    MDR report key: 2222676 · Received July 20, 2011

    Report

    Report Number
    9681834-2011-00033
    Date Received
    July 20, 2011
    Date of Event
    June 30, 2011
    Report Date
    June 30, 2011
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DTZ
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TERUMO HAS RECEIVED THE ACTUAL DEVICE FOR INVESTIGATION; HOWEVER, THE INVESTIGATION IS NOT YET COMPLETE. TERUMO PLANS ON SUBMITTING A FOLLOW-UP REPORT WHEN THE INVESTIGATION IS COMPLETED AND MORE INFORMATION 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, THE HOLDER FOR THE FX OXYGENATOR WAS BENT. THERE WAS NO PATIENT INVOLVEMENT AS THIS OCCURRED DURING SET-UP. SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOLDER FOR FX15/25 OXYGENATOR HOLDER DTZ TERUMO CORPORATION, ASHITAKA 1XX*CXH15 101201

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK