BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FX OXY W/HR & ART FILTER

    MDR report key: 2980811 · Received February 21, 2013

    Report

    Report Number
    9681834-2013-00028
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    February 5, 2013
    Report Date
    February 5, 2013
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DTZ
    PMA / PMN Number
    K071494
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    TERUMO HAS NOT RECEIVED THE ACTUAL DEVICE FOR EVALUATION; THEREFORE, AND INVESTIGATION HAS YET TO BE COMPLETED. TERUMO PLANS ON SUBMITTING A FOLLOW-UP REPORT WHEN THE INVESTIGATION IS COMPLETE 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, DURING PRIME, THE OXYGENATOR LEAKED AT THE CONNECTOR SITE. NO PATIENT INVOLVEMENT AS THIS OCCURRED DURING PRIME. PRODUCT WAS CHANGED OUT. SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77043 FX OXY W/HR & ART FILTER BLOOD-GAS OXYGENATOR DTZ TERUMO CORPORATION, ASHITAKA 1CX*FX15RW30 85921

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK