BEUDAMED
    FDA Adverse Event Death Summary report: N

    OMNI PUMP - ABBOTT

    MDR report key: 41048 · Received September 25, 1996

    Report

    Report Number
    41048
    Event Type
    Death
    Date Received
    September 25, 1996
    Date of Event
    September 13, 1996
    Report Date
    September 18, 1996
    Manufacturer
    ABBOTT LABS
    Product Code
    FRN
    Report Source
    User Facility report
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WAS POST-OP. HAD HEPARIN RUNNING THRU PUMP. PUMP REGULATED AND FAILED TO FUNCTION. PT RECEIVED TOO MUCH HEPARIN NECESSITATING RETURN TO OR TO EVACUATE CLOTS. RECEIVED 250CC IN 7HRS INSTEAD 21CC/7HR. PER CALL TO RPTR: PROCEDURE WAS FEM POP BYPASS. FACILITY IS OF THE OPINION THAT CLOTTING WAS RESULT OF HYPERINFUSION OF HEPARIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNI PUMP - ABBOTT PUMP 4000 PLUS FRN ABBOTT LABS 40051-04-08 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Death| R