BEUDAMED
    FDA Adverse Event Death Summary report: N

    SIGMA 8000 INFUSION PUMP

    MDR report key: 791849 · Received December 7, 2006

    Report

    Report Number
    MW1041306
    Event Type
    Death
    Date Received
    December 7, 2006
    Date of Event
    December 5, 2006
    Report Date
    December 7, 2006
    Manufacturer
    SIGMA INTERNATIONAL
    Product Code
    FRN
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    RECEIVED A CALL FROM MD WITH REPORT THAT DURING INFUSION OF MYCOMINE DOSE, THE PT'S WIFE REPORTED HEARING A "LOUD POP" AND THE PT COLLAPSED AND DIED. AUTOPSY RESULTS REVEALED A MASSIVE AIR EMBOLISM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGMA 8000 INFUSION PUMP SIGMA 8000 FRN SIGMA INTERNATIONAL 8000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Death ON OTHER MULTIPLE P.O. MEDICATION, ALSO USING| PREFILLED SALINE AND HEPARIN SYRINGES FOR FLUSHING| OF TRIPLE LUMEN CENTRAL LINE.