BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADMINISTRATION SET

    MDR report key: 135387 · Received November 25, 1997

    Report

    Report Number
    2016493-1997-00216
    Event Type
    Malfunction
    Date Received
    November 25, 1997
    Date of Event
    October 13, 1997
    Manufacturer
    ALARIS MEDICAL SYSTEMS
    Product Code
    FPA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S REPORT DATE 2/9/1998. ONE SET WAS RECEIVED AND WAS VISUALLY AND FUNCTIONALLY TESTED. THE SET WAS TESTED AT SEVERAL RATES AND TIMES ON THE MODEL 598 FSO INSTRUMENT AND NO AIR WAS NOTED IN THE LINE AND THE PUMP ALARMED EMPTY CONTAINER EACH TIME. THERE WAS NO VISIBLE AIR BELOW THE DRIP CHAMBER OR IN THE TUBING BELOW THE AIR IN LINE ADAPTER. THERE WERE NO DEFECTS FOUND WITH THE RETURNED SET. UNABLE TO DUPLICATE THE REPORT OF AIR BELOW THE PUMP.

    Description of Event or Problem · 1

    IT WAS REPORTED ON TWO OCCASIONS AIR IN LINE WAS NOTED IN THE IV SETS. THERE WAS NO RESULTANT PT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADMINISTRATION SET IV TUBING FPA ALARIS MEDICAL SYSTEMS 59593 B75716-4

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN