BEUDAMED
    FDA Adverse Event Death Summary report: N

    PALL SMALL VOLUME HEAT & MOISTURE EXCHANGER

    MDR report key: 58349 · Received December 27, 1996

    Report

    Report Number
    2432733-1996-00010
    Event Type
    Death
    Date Received
    December 27, 1996
    Report Date
    December 24, 1996
    Manufacturer
    PALL BIOMEDICAL PRODUCTS COMPANY
    Product Code
    BYD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION/ANALYSIS: FROM INITIAL DESCRIPTION: VOMITTING INTO DEVICE, WHICH WAS PLACED IN BREATHING CIRCUIT, INDICATES THAT BREATHING TUBE WAS IMPROPERLY PLACED. DEVICE LABEL STATES THAT "IF PT PRODUCES EXUDATES OR BLEEDING, WHICH ENTERS FILTER, THEN FILTER MUST BE REMOVED." USER APPARENTLY DID NOT ADHERE TO THAT INSTRUCTION. FROM LIMITED INFO AVAILABLE, THIS EVENT APPEARS MOST LIKEY CAUSED BY USER ERROR, NOT BY DEVICE FAILURE. THIS IS ONLY SUCH REPORT (VOMITTING IN DEVICE) EVER RECEIVED FOR THIS TYPE OF DEVICE. UNLESS SUBSTANTIALLY SIGNIFICANT INFO BECOMES AVAILABLE, THIS CONSTITUTES FINAL REPORT.

    Description of Event or Problem · 1

    A 13 YR OLD BOY WAS IN FOR MINOR KNEE OPERATION, WHEN PT VOMITED DURING ANAESTHESIA WHICH CAUSED BLOCKAGE OF THE DEVICE. PT DIED UNDER ANAESTHESIA. NO FURTHER INFO IS AVAILABLE AT THIS TIME. IT SHOULD BE NOTED THAT THE DEVICE HOUSING IS TRANSPARENT TO ALLOW ANY SECRETIONS IN THE HOUSING TO BE IMMEDIATELY APPARENT. IN ADDITION, THE INSTRUCTIONS FOR USE FOR THE DEVICE INCLUDES A PRECAUTION TO IMMEDIATELY REMOVE THE DEVICE IF PT PRODUCES EXUDATES OR BLEEDING WHICH ENTER THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALL SMALL VOLUME HEAT & MOISTURE EXCHANGER SMALL VOLUME HEAT & MOISTURE EXCHANGER BYD PALL BIOMEDICAL PRODUCTS COMPANY BB25 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Death