BEUDAMED
    FDA Adverse Event Death Summary report: N

    CADD-1 PUMP

    MDR report key: 14393 · Received May 12, 1994

    Report

    Report Number
    1024597-1994-00001
    Event Type
    Death
    Date Received
    May 12, 1994
    Date of Event
    March 19, 1994
    Report Date
    March 31, 1994
    Manufacturer
    PHARMACIA DELTEC, INC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT WAS ON A STABLE DOSE OF FLOLAN AT 29 NG/KG/MIN. ON MARCH 19, 1994, SHE WAS AT A MOVIE THEATER AAAND INADVERTENTLY DISCONNECTED THE BATTERY FROM HER PORTABLE INFUSION PUMP FOR AN UNKNOWN PERIOD OF TIME. BEFORE SHE COULD REPLACE THE BATTERY, SHE BECAME UNCONSCIOUS AND PULSELESS. SHE WAS RESUSSCITATED BY MEMBERS OF THE AUDIENCE AND SUBSEQUENTLY BY EMTS. THE EMTS TRANSPORTED HEEEER TO A LOCAL HOSPITAL. SHE WAS PERSISTENTLY HYPOTENSIVE (SYSTOLIC BP 55), AND UNRESPONSIVE WITH FIXED AND DIALATED PUPILS FOR THE REMAINDER OF HER HOSPITALIZATION. SHE WAS TREATED WITH DOPPAAAMINE AND LEVOPHED AT HIGH DOSES, BUT HYPOTENSION PRESISTED. FLOOLAN WAS REINSTITUTED AT 2/3 OF THE ORIGINAL DOSE TO TRY TO DECREASE THE PVR AAND IMPROVE CARDIAC OUTPUT. DESPITE THESE MEASURES, THE PT DIED APPROX 6 HRS AFTER THE EVENT BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CADD-1 PUMP PORTABLE INFUSION PUMP FRN PHARMACIA DELTEC, INC. 5100 HSX

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Death| H FLOLAN - 29 NG/KG/MIN IV| WARFARIN - 2.5 MG/DAY ORAL - 6/93-3/19/94| 6/7/93 - 3/19/94