BEUDAMED
    FDA Adverse Event Other Summary report: N

    HUMIDIFIER ADAPTER

    MDR report key: 173230 · Received June 16, 1998

    Report

    Report Number
    1419377-1998-00001
    Event Type
    Other
    Date Received
    June 16, 1998
    Date of Event
    April 20, 1998
    Report Date
    June 16, 1998
    Manufacturer
    AUTOMATIC LIQUID PACKAGING, INC.
    Product Code
    BTT
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    FACILITY WAS USING AUTOMATIC LIQUID PACKAGING, INC. HUMIDIFIER ADAPTER AND STERILE WATER INHALATION SOLUTION ON PT. THE OXYGEN FLOW SHOULD BE SET AT 4.0 LITERS PER MINUTE (LABEL INSTRUCTION), ALTHOUGH RATE OF FLOW WAS NOT RECORDED. LABELING INDICATES HUMIDIFIER ADAPTER BE TESTED FOR AUDIBLE ALARM PRIOR TO PT SET-UP. IN THIS INSTANCE ADAPTER WAS NOT TESTED FOR AUDIBLE ALARM PRIOR TO USE. DURING COURSE OF THERAPY, TECHNICIAN ACCIDENTALLY PUSHED BED WHEEL OVER OXYGEN TUBING CRIMPING TUBE, CUTTING OFF OXYGEN TO PT AND AUDIBLE ALARM DID NOT SOUND. THERAPIST REMOVED BED WHEELS AND ONLY SHORT PERIOD OF TIME HAD LAPSED CAUSING NO INJURY TO PT. HUMIDIFIER ADAPTER WAS DISCARDED BY FACILITY AND LOT NUMBER WAS NOT RECORDED. AS SUCH, INTERNAL INVESTIGATION AT AUTOMATIC LIQUID PACKAGING, INC. CANNOT BE INITIATED. IT IS CO'S UNDERSTANDING THAT HOSP IS NOW TESTING HUMIDIFIER ADAPTERS FOR AUDIBLE ALARM PRIOR TO SET-UP. CO IS REPORTING THIS INCIDENT AS 30 DAY MDR PER 21 CFR 803.3(D)(6) USER ERROR. THERE WILL NO FOLLOW-UP INFO--THIS IS FINAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUMIDIFIER ADAPTER HUMIDIFIER ADAPTER BTT AUTOMATIC LIQUID PACKAGING, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other