BEUDAMED
    FDA Adverse Event Death Summary report: N

    CONTINUOUS FLOW PUMP

    MDR report key: 280124 · Received May 31, 2000

    Report

    Report Number
    MW1019026
    Event Type
    Death
    Date Received
    May 31, 2000
    Date of Event
    May 17, 2000
    Report Date
    May 22, 2000
    Manufacturer
    KARL STORZ CORP. ENDOSCOPY AMERICA, INC.
    Product Code
    HIG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WV, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A PT W/ASA II SCHEDULED FOR D & C AND HYSTEROSCOPY WITH LOCAL AND TIVA. SURGERY BEGUN AT 11:55 AM. PT CODED AT 12 PM, EXPIRED AT 1:01 PM IN OR. CONTINUOUS FLOW PUMP WAS INCORRECTLY CONNECTED. THE MACHINE LABELED FROM PT HAD TUBING THAT WAS CONNECTED TO SUCTION CANISTER. TUBING FROM MACHINE LABELED TO WASTE WAS CONNECTED TO PT. INVESTIGATED EQUIPMENT INVOLVED IN PT INCIDENT. INITIAL FEEDINGS - PUMP SET AT 5 AND HOSES REVERSED. TESTED PUMP OPERATION. PERFORMED ELECTRICAL SAFETY. 15 OHM 10UA, VACUUM WAS 602 MMHG ON "FROM PT" SIDE. ALL CONTROLS AND INDICATORS ARE FUNCTIONING PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTINUOUS FLOW PUMP CONTINUOUS FLOW PUMP HIG KARL STORZ CORP. ENDOSCOPY AMERICA, INC. 27224P *

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Death