BEUDAMED
    FDA Adverse Event Death Summary report: N

    GEMSTAR PAV SPLIT SET

    MDR report key: 673189 · Received February 7, 2006

    Report

    Report Number
    9615050-2006-00214
    Event Type
    Death
    Date Received
    February 7, 2006
    Date of Event
    January 1, 2004
    Report Date
    January 19, 2006
    Manufacturer
    HOSPIRA DE COSTA RICA LTD.
    Product Code
    FPA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE USTOMER CONTACT REPORTED AN EPIDURAL TUBING SET DELIVERING AN UNSPECIFIED MEDICATION WAS INADVERTENTLY CONNECTED TO THE PT'S IV CANNULA; SUBSEQUENTLY, A PT DEATH OCCURRED. NO SPECIFIC PT INFO INCLUDING CAUSE OF DEATH, PUMP PROGRAMMING, OR EVENT DETAILS WERE PROVIDED. THE CUSTOMER CONTACT INDICATED THAT THERE WAS NO FAULT ON THE PART OF THE PUMP OR THE SET, BUT AN ANESTHETIST AND A WIDWIFE HAD APPARENTLY MISTAKENLY CONNECTED THE EPIRURAL SET TO AN INTRAVENOUS CANNULA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEMSTAR PAV SPLIT SET ADMINISTRATION SET FPA HOSPIRA DE COSTA RICA LTD. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death