BEUDAMED
    FDA Adverse Event Death Summary report: N

    MULTI-LUMEN CVC KIT: 3-L 7 FR X 8IN (20 C

    MDR report key: 1696651 · Received May 21, 2010

    Report

    Report Number
    1036844-2010-00148
    Event Type
    Death
    Date Received
    May 21, 2010
    Date of Event
    May 6, 2010
    Report Date
    May 20, 2010
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DQO
    PMA / PMN Number
    K862056
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). SAMPLE WILL NOT BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER THE CATHETER WAS PLACED, THE NURSE WAS TRYING TO DRAW BLOOD OUT OF THE PROXIMAL PORT AND WAS UNABLE TO GET A RETURN. THIS OCCURRED RIGHT WHEN THE LINE WAS PLACED, SO IT WASN'T IN THE PT LONG AT ALL TO BE OCCLUDED. THE MEDIAL AND DISTAL LINES WERE OPAQUE AND THE PROXIMAL LUMEN COULD STILL BE FLUSHED BUT NO BLOOD DRAWS. ADDITIONAL INFO RECEIVED ON 5/11/2010 BY THE INTENSIVE CARE UNIT (ICU) RN STATED THAT THE CATHETER HAD BEEN PLACED IN THE PT'S LEFT SUBCLAVIAN VEIN. THE FEMALE PT CAME INTO THE ICU WITH THE CENTRAL VENOUS PRESSURE (CVP) NOT READING WHEN ATTACHED TO THE BROWN PORT. AT WHICH TIME, IT WAS SWITCHED TO THE BLUE PORT AND WORKED FINE. SHE ALSO NOTED THAT THE PT LATER EXPIRED IN THE ICU FROM OTHER MEDICAL CONDITIONS NOT RELATED TO THE CATHETER ISSUE. NO FURTHER DETAILS ARE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LUMEN CVC KIT: 3-L 7 FR X 8IN (20 C ADULT MULTI-LUMEN CATHETER PRODUCTS DQO ARROW INTL., INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death