BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CVC SET: 3-LUMEN 4FR X 1 3CM

    MDR report key: 1201489 · Received October 17, 2008

    Report

    Report Number
    3006425876-2008-00003
    Event Type
    Injury
    Date Received
    October 17, 2008
    Date of Event
    September 24, 2008
    Report Date
    October 13, 2008
    Manufacturer
    ARROW INTL INC.
    Product Code
    DQO
    PMA / PMN Number
    K862056
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT THIS EVENT INVOLVED A FEMALE PT WITH A DIAGNOSIS OF HEART VCC. THE TRIPLE LUMEN CATHETER WAS INSERTED INTO THE SUBCLAVIAN VEIN FOR CARDIO SURGICAL TREATMENT. CATECHOLAMINES PASSED BACK THROUGH PARALLEL LUMEN, RESULTING IN VARIATIONS IN BLOOD PRESSURE, WITH CONSECUTIVE WORSE BLOOD SUPPLY TO THE LUNGS AND LOW OXYGEN SATURATION VALUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CVC SET: 3-LUMEN 4FR X 1 3CM PEDIATRIC MULTI-LUMEN CATHETER PRODUCTS DQO ARROW INTL INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK