BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSION PUMP/CONTROLLER

    MDR report key: 328690 · Received April 19, 2001

    Report

    Report Number
    2016493-2001-00059
    Event Type
    Malfunction
    Date Received
    April 19, 2001
    Report Date
    April 16, 2001
    Manufacturer
    ALARIS MEDICAL SYSTEMS
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE OCCURENCE OF 161, 162, AND 163 ERROR CODES INDICATING PUMP MOTOR STALLS HAD OCCURRED DURING CLINICAL USE OVER THE PERIOD FROM 9/1998 THROUGH 3/1999. WHILE EXACT USE CONDITIONS ARE NOT AVAILABLE, IT IS BELIEVED THAT THE EVENTS WERE NOTED AT FLOW RATES <20ML/HR. THE PTS WERE REPORTEDLY NOT INJURED BY THE EVENTS. THE ALARM SYSTEMS REPORTEDLY FUNCTIONED AS INTENDED, NOTIFYING THE USER OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18008 INFUSION PUMP/CONTROLLER INFUSION PUMP/CONTROLLER FRN ALARIS MEDICAL SYSTEMS 1311AX01AA *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN