BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O'BRIEN KMI KM 70

    MDR report key: 87962 · Received May 1, 1997

    Report

    Report Number
    MW1011245
    Event Type
    Malfunction
    Date Received
    May 1, 1997
    Date of Event
    April 13, 1997
    Report Date
    April 14, 1997
    Manufacturer
    KNIGHT MEDICAL INC
    Product Code
    LZH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    FIBERSOURCE 330CC/2 HR.(165CC/HR) PER G-TUBE. AT 1915 TUBE FEEDING MACHINE BEEPED COMPLETED & NURSE SHUT IT OFF. RN NOTICED THE DRIP CHAMBER WAS DRIPPING RAPIDLY. THE MACHINE VOLUME READ 330CC AS ORDERED. THIS NURSE SHUT OFF THE DRIP CHAMBER VALVE & LOOKED TO SEE WHEN THE BOTTLE WAS HUNG. IT WAS HUNG AT 1300 ON THIS SAME DAY. THE BOTTLE HAD INFUSED 1125CC TOTAL OUT OF THE POSSIBLE 1500CC IN THE BOTTLE. THE MOST THAT SHOULD HAVE BEEN INFUSED WOULD BE 330CC FROM 1300 & 330CC FROM 1800 TOTAL OF 660CC. (465CC TOO MUCH & POSSIBLY MORE IF THE HAND TIME 1300 WAS NEAR THE END OF THE NOON FEEDING.) NO EMESIS NOTED OVER NEXT 6 HOURS. RESIDENT'S HOB ELEVATED WHEN WENT TO BED AT 2030. LSC, COLOR PINK, SKIN WARM AND DRY. MD NOTIFIED & AGREES TO HOLD 12MN FEEDING & NOTIFY IF ANY PROBLEMS FROM FEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 O'BRIEN KMI KM 70 FEEDING PUMP LZH KNIGHT MEDICAL INC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other