BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIFLO COMPANION ENTERAL NUTRITION PUMP

    MDR report key: 110898 · Received August 1, 1997

    Report

    Report Number
    1528738-1997-00053
    Event Type
    Malfunction
    Date Received
    August 1, 1997
    Date of Event
    July 18, 1997
    Report Date
    July 31, 1997
    Manufacturer
    ROSS PRODUCTS DIVISION ABBOTT LABORATORIES
    Product Code
    LZH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMISSION DATE OF THIS REPORT: 07/07/1998. MFG EVENT ID: RPIC 305843. OBSERVATIONS OF UNIT AS RECEIVED IN LAB: PUMP RELEASES & ATTACHES TO CHARGER CASE WITHOUT DIFFICULTY. EXCESSIVE SPILLAGE ON PUMP CASE. CASSETTE INSERTS INTO CAVITY & RELEASES FREELY. CONTROL KNOB FUNCTIONAL & MOVES FREELY. PUMP-"DC" JACK IS NOT DAMAGED & FREE OF EXCESSIVE SPILLAGE. CHARGER-"DC" CONNECTOR IS NOT DAMAGED & FREE OF EXCESSIVE SPILLAGE. TOUCH PANEL IS FUNCTIONAL, LIGHTS ILLUMINATE & AUDIBLE ALARMS SOUND. PUMP IS OPERATIONAL ON BOTH DIRECT CURRENT AND ALTERNATING CURRENT POWER. PRODUCT DRIED INSIDE OF CASSETTE OPENING. TESTING WAS COMPLETED USING BOTH FEEDING RATES. PUMP WAS RUN FOR 4 HOURS ON BOTH RATES. SAME BAG SET AND STOP WATCH USED FOR BOTH TESTS. RESULTS FOR 100 ML TEST: CALCULATED DELIVERY 400 ML. ACTUAL DELIVERY 430 ML. VOLUME FED 400 ML. TIME FRAME 4 HOURS. PUMP DELIVERED WITHIN SPECIFICATION DURING BOTH TESTS. EMPTY ALARMS WERE TESTED AS PER STANDARD OPERATING PROCEDURES MANUAL TITLE MQH 104, SECTIONS M & N. WITHOUT A CASSETTE ALARMS VISUAL & AUDIBLE ACTIVATED AT 7.25/100 SECONDS. WITH AN EMPTY CASSETTE IN PLACE, BOTH VISUAL & AUDIBLE ALARMS ACTIVATED AT 51.92/100 SECONDS. BOTH TESTS WERE IN SPECIFICATIONS. CUSTOMER COMPLAINT WAS NOT CONFIRMED.

    Description of Event or Problem · 1

    THE REPORTER STATED THE PUMP UNDER-DELIVERED AND THAT THE TUBE WAS EMPTY AND THE PUMP DID NOT ALARM. THE PT IS FED CONTINUOUSLY FROM 4:30PM TO 6:00AM. ENTERNAL FEEDING SOLUTION AND WATER ARE ADDED TO THE FEEDING CONTAINERS 3 TIMES PER DAY. IT WAS UNCLEAR FROM THE REPORTER'S DESCRIPTION AS TO THE EXTENT OF THE UNDER-DELIVERY. THERE WAS NO ILLNESS, INJURY OR MEDICAL INTERVENTION RESULTING FROM THE EVENT. ONE PT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXIFLO COMPANION ENTERAL NUTRITION PUMP 80 LZH PUMP, INFUSION, ENTERAL, EXTERNAL LZH ROSS PRODUCTS DIVISION ABBOTT LABORATORIES 84 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other NONE REPORTED.