BEUDAMED
    FDA Adverse Event Death Summary report: N

    HUDSON HUMID-VENT FILTER 2

    MDR report key: 1651578 · Received April 1, 2010

    Report

    Report Number
    8040412-2010-00007
    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 BEEN RECEIVED BY THE MFR FOR INVESTIGATION, BUT INVESTIGATION IS INCOMPLETE AT THE 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 THREE TIMES. THIS IS THE FIRST OF THREE REPORTS REGARDING THIS COMPLAINT. THERE WAS A DEATH REPORTED, BUT AFTER CONTACTING THE REPORTER NUMEROUS TIMES, IT IS UNCLEAR WHICH EVENT OF THE THREE 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