BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FX OXY W/HR & ART FILTER

    MDR report key: 3971138 · Received April 29, 2014

    Report

    Report Number
    9681834-2014-00132
    Event Type
    Malfunction
    Date Received
    April 29, 2014
    Date of Event
    March 27, 2014
    Report Date
    March 27, 2014
    Manufacturer
    TERUMO CORPORATION
    Product Code
    DTZ
    PMA / PMN Number
    K130520
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TERUMO HAS NOT RECEIVED THE ACTUAL DEVICE FOR EVALUATION; THEREFORE, THE INVESTIGATION HAS YET TO BE COMPLETED. 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, DURING PRIME, THE VENOUS RESERVOIR OUTLET LEAKED. NO PATIENT INVOLVEMENT; PRODUCT WAS NOT CHANGED OUT; SURGERY WAS SUCCESSFULLY COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256197 FX OXY W/HR & ART FILTER BLOOD GAS OXYGENERATOR DTZ TERUMO CORPORATION 1CX-FX15RE30 130828

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK