BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUMED

    MDR report key: 753925 · Received October 27, 2005

    Report

    Report Number
    1723533-2005-00049
    Event Type
    Malfunction
    Date Received
    October 27, 2005
    Report Date
    September 27, 2005
    Manufacturer
    MCKINLEY MEDICAL,LLC
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ANAYLSIS: DEVICE WAS ORIGINALLY MANUFACTURED BY MEDEX, INC. IN 03/1991 AND IS NOW SUPPORTED BY MCKINLEY MEDICAL. MCKINLEY'S SERVICE TECHNICIAN EVALUATED THE PUMP AND WAS UNABLE TO DUPLICATE THE REPORTED MALFUNCTION. WHEN TESTED PER MCKINLEY SERVICING PROCEDURES, THE PUMP FUNCTIONED WITHIN SPECIFICATION THROUGHOUT THE NORMAL RANGE OF OPERATION. THERE WAS NO SIGN OF PHYSICAL DAMAGE. THE UNDER-DELIVERY CANNOT BE CONFIRMED. CAUSE OF FAILURE: THE REPORTED MALFUNCTION COULD NOT BE DUPLICATED AND A CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    MCKINLEY MEDICAL HAS BECOME AWARE OF A REPORTABLE EVENT WITH AN AMBULATORY INFUSION SYSTEM. A CUSTOMER REPORTED THAT AN ELECTROMECHANICAL AMBULATORY INFUSION PUMP UNDER-DELIVERED MEDICATION DURING AN INFUSION REGIMEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUMED ELECTROMECHANICAL AMBULATORY INFUSION PUMP FRN MCKINLEY MEDICAL,LLC IM300 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * DISPOSABLE ADMINISTRATION SET| DISPOSABLE DRUG RESERVOIR