BEUDAMED
    FDA Adverse Event Death Summary report: N

    SIMS PORTEX HEPA FILTER

    MDR report key: 270492 · Received March 21, 2000

    Report

    Report Number
    MW1018461
    Event Type
    Death
    Date Received
    March 21, 2000
    Date of Event
    March 18, 2000
    Report Date
    March 20, 2000
    Manufacturer
    SIMS PORTEX, INC.
    Product Code
    CAH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AT APPROX 12:40 AM, PT'S VENTILATOR ALARM SOUNDED. PT WAS ASSESSED IMMEDIATELY BY A NURSE, AND FOUND TO BE CYANOTIC, WITHOUT RESPIRATIONS. CODE BLUE PERFORMED. RESUSCITATION ATTEMPTS WERE UNSUCCESSFUL. AT 4PM THE RESPIRATORY THERAPIST NOTED THAT THE VENT FILTER WAS BLOCKED, NOT ALLOWING AIR EXCHANGE THROUGH THE FILTER. THERE WAS NO VISIBLE EVIDENCE OF BLOCKAGE UPON VISUAL EXAMINATION. BLOCKAGE OF FILTER, AND SUBSEQUENT BLOCKAGE OF AIR EXCHANGE IS FELT TO BE RELATED TO PT'S DEATH. PT RECEIVED AN ALBUTEROL NEBULIZER TREATMENT AT 10 MINS PRIOR TO THE CODE BLUE. RESPIRATORY THERAPISTS HAVE REPORTED THAT THE ALBUTEROL CREATES A "FOAM" WHEN THE TREATMENT IS GIVEN. THE RELATIONSHIP OF THE ALBUTEROL AND THE FILTER BLOCKAGE NEEDS FURTHER TESTING AND INVESTIGATION. HOSP IS QUESTIONING WHETHER THE "FOAM" OR INGREDIENTS IN THE ALBUTEROL CONTRIBUTED TO THE PROBLEM WITH THE FILTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIMS PORTEX HEPA FILTER H.M.E. HEAT MOISTER EXCHANGER CAH SIMS PORTEX, INC. 002895 AA0084 OR AA 0083

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death EXP DATE 11/00| 1) SIEMEN'S 900C VENTILATOR,| 3) ALBUTEROL NEBULIZER .83%, LOT #9MYW621,| 2) HUDSON RCI CONCHA FOUR HEATER.