BEUDAMED
    FDA Adverse Event Death Summary report: N

    4.5 FR DUAL PICC (18G PROXIMAL) HDC

    MDR report key: 154013 · Received February 27, 1998

    Report

    Report Number
    154013
    Event Type
    Death
    Date Received
    February 27, 1998
    Date of Event
    February 19, 1998
    Report Date
    February 25, 1998
    Manufacturer
    HDC CORP
    Product Code
    DQO
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ENTRAPMENT OF PICC LINE IN TRICUSPID VALVE INTERFERING CARDIAC OUTPUT OF CARDIOWEST ARTIFICAL HEART. (PICC LINE WAS PLACED INTO RT ANTECUBITAL 2/12/98 AND SUTURED AT INSERTION SITE AFTER RADIOLOGICAL VERIFICATION OF CORRECT PLACEMENT, AWAY FROM VALVES. PICC INSERTION SITE REMAINED SUTURED, DRY AND INTACT AT TIME OF DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4.5 FR DUAL PICC (18G PROXIMAL) HDC INTAVENOUS LINE DQO HDC CORP 395-60 1036

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Death CARDIOWEST ARTIFICAL HEART DEVICE