BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SABRATEK HOMERUN

    MDR report key: 330158 · Received April 24, 2001

    Report

    Report Number
    330158
    Event Type
    Malfunction
    Date Received
    April 24, 2001
    Date of Event
    April 6, 2001
    Report Date
    April 20, 2001
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT REPORTED THAT INFUSION BAG WAS EMPTY. RN MADE VISIT & FOUND THAT INDEED THE BAG WAS EMPTY, BUT SHOULD HAVE HAD JUST OVER 99CC LEFT OF ITS ORIGINAL 100CC VOLUME. PROGRAM DOWNLOAD WAS DONE ON 04/16/2001. (UNABLE TO DO PRIOR AS CABLE CONNECTOR WAS BROKEN & MFR SENT WRONG REPLACEMENT.) PUMP WAS PROGRAMMED TO DELIVER MEDICATION INTERMITTENTLY EVERY 8 HOURS BUT DELIVERED ENTIRE BAG IN 3 HRS PERIOD BETWEEN 13:42-16:45.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18849 SABRATEK HOMERUN AMBULATORY INFUSION PUMP FRN BAXTER HEALTHCARE 6060 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other