BEUDAMED
    FDA Adverse Event Death Summary report: N

    HUDSON HUMID-VENT FILTER 2

    MDR report key: 1651580 · Received April 1, 2010

    Report

    Report Number
    8040412-2010-00009
    Event Type
    Death
    Date Received
    April 1, 2010
    Date of Event
    March 11, 2010
    Report Date
    March 12, 2010
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CAH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HAS NOT BEEN RECEIVED BY THE MFR FOR INVESTIGATION YET. INVESTIGATION IS INCOMPLETE AT TIME OF THIS REPORT. A F/U REPORT WILL BE SENT WHEN COMPLETED.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: WHEN THE HME WAS DISCONNECTED FROM THE PT WHILE STILL BEING CONNECTED TO THE PRESSURIZED CIRCUIT, WHITE FLAKES BLEW OUT OF THE HME. THIS EVENT OCCURRED 3 TIMES. THIS IS THE THIRD OF 3 REPORTS REGARDING THIS COMPLAINT. THERE WAS A DEATH REPORTED, BUT AFTER CONTACTING THE REPORTER NUMEROUS TIMES, IT IS UNCLEAR WHICH EVENT OF THE 3 INVOLVED A DEATH. IT IS REPORTED THAT THE PHYSICIAN ATTENDING THE PT DID NOT FEEL THIS EVENT CONTRIBUTED TO THE PT'S DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUDSON HUMID-VENT FILTER 2 HUMID-VENT FILTER CAH TELEFLEX MEDICAL NA 200947

    Patients

    Seq Age Sex Outcome Treatment
    1 Death