BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FX OXY W/HR & ART FILTER

    MDR report key: 3131087 · Received May 22, 2013

    Report

    Report Number
    9681834-2013-00067
    Event Type
    Injury
    Date Received
    May 22, 2013
    Date of Event
    May 8, 2013
    Report Date
    May 8, 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 RECEIVED THE ACTUAL DEVICE FOR EVAL; HOWEVER, AN INVESTIGATION HAS YET TO BE COMPLETED. TERUMO PLANS ON SUBMITTING A F/U REPORT WHEN THE INVESTIGATION IS COMPLETE AND 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, DURING SETUP, THE PURGE LINE ON TOP OF THE OXYGENATOR WAS SEVERED. NO PT INVOLVEMENT AS THIS OCCURRED DURING SETUP. PRODUCT WAS CHANGED OUT. SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227729 FX OXY W/HR & ART FILTER BLOOD-GAS OXYGENATOR DTZ TERUMO CORPORATION ASHITAKA 1CX FX25RW 130227

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK