BEUDAMED
    FDA Adverse Event Death Summary report: N

    ADULT FILTERED HYGROSCOPIC CONDENSER HUMIDIFIER W/GAS SAMPLI

    MDR report key: 474975 · Received July 28, 2003

    Report

    Report Number
    8030928-2003-00001
    Event Type
    Death
    Date Received
    July 28, 2003
    Date of Event
    January 1, 2003
    Manufacturer
    ICOR AB
    Product Code
    BYD
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A CRITICALLY ILL PT WAS ON A VENTILATOR WITH A CHEST TUBE IN THE ICU. AT THE TIME OF INCIDENT, THE HCH FILTER WAS FULL OF WATER AND SECRETIONS AND A PIECE APPEARED TO BE LOOSE INSIDE THE FILTER. THE PT ALLEGEDLY HAD LOW LEVELS OF OXYGEN ON THAT DATE. THE THERAPIST MENTIONED THAT HOSP POLICY IS TO CHANGE THE FILTER EVERY 24 HOURS OR BEFORE IF IT IS NOTICED THAT IT IS FULL OF SECRETIONS. THE THERAPIST DID OT KNOW WHEN THE FILTER WAS LAST CHANGED PRIOR TO THE INCIDENT. THE REPORT ALLEGES THAT THE PT DIED A WEEK LATER. ICOR AB HAS NOT BEEN ABLE TO EXAMINE THE ACTUAL PRODUCT, AS IT IS NOT AVAILABLE FROM THE HOSP. IT SEEMS TO HAVE BEEN DISCARDED ICOR AB HAS BEEN UNABLE TO ASCERTAIN THE EXACT DATE OF INCIDENT. THE INVESTIGATION IS CONTINUING, ALTHOUGH IT APPEARS TO BE DEVICE MAINTENANCE AND USER ERROR CONTRIBUTED TO THE EVENT. ALSO, THE LABEL STATES NOT TO USE PTS WITH THICK, TENACIOUS SECRETIONS THAT THIS PT MAY HAVE BEEN PRODUCING, AND TO CHANGE WHEN REQUIRED OR EVERY 24 HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT FILTERED HYGROSCOPIC CONDENSER HUMIDIFIER W/GAS SAMPLI HYGROSCOPIC CANDENSER HUMIDIFIER BYD ICOR AB NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Death