BEUDAMED
    FDA Adverse Event Death Summary report: N

    NEPTUNE 2 ROVER ULTRA (120V)

    MDR report key: 1888349 · Received October 29, 2010

    Report

    Report Number
    1811755-2010-01563
    Event Type
    Death
    Date Received
    October 29, 2010
    Date of Event
    August 2, 2010
    Report Date
    October 4, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    FYD
    PMA / PMN Number
    K012991
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACCOUNT STATED THAT THERE WAS NO EQUIPMENT FAILURE. THE EQUIPMENT USED IN THE PROCEDURE WAS NOT HELD, SO THE SERIAL NUMBER OF THE NEPTUNE USED IS UNK. THIS REPORT WILL BE UPDATED WHEN THE QUALITY INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE MFR'S SALES REP REPORTED, HE WAS MADE AWARE THROUGH INFORMAL REPORTS FROM HOSPITAL PERSONNEL THAT THERE WAS A DEATH POSSIBLY RELATED TO THE NEPTUNE ROVER. AS A RESULT OF THIS REPORT, THE MFR CONTACTED THE HOSPITAL'S RISK MGMT DEPT AND WAS INFORMED THAT ON JULY 30, 2010, A PNEUMONECTOMY WAS COMPLETED ON A (B)(6) MALE WHO SUFFERED FROM CANCER OF THE LUNG. WHILE PREPPING THE PT FOR RECOVERY, THE OPERATING ROOM TECH SAW DARK BLOOD IN THE PT'S UNCLAMPED CHEST TUBE THAT WAS IN THE PLEURAL SPACE. THE TECH THEN USED THE SUCTION FROM THE NEPTUNE TO SUCTION THE BLOOD SO, IT WOULD NOT CLOT. THIS RESULTED IN BLOOD SUCTIONING OUT OF THE PT AND POURING IN THE NEPTUNE. AFTER SEVERAL ATTEMPTS MADE BY OPERATING ROOM PERSONNEL, THE BLEEDING COULD NOT BE STOPPED AND THE PT DIED. ON AUGUST 9, 2010, THE PRELIMINARY AUTOPSY RESULTS STATED THAT THE CAUSE OF DEATH WAS DUE TO A RIGHT INTRATHORACIC HEMORRHAGE DUE TO THE CONNECTION OF THE CHEST TUBE TO A HIGH POWER SUCTION DEVICE. THE ACCOUNT STATED THAT THEY DID NOT KNOW RIGHT AWAY WHAT HAD CAUSED THE EVENT SO, THE EQUIPMENT USED IN THE PROCEDURE WAS NOT HELD. THE SERIAL NUMBER OF THE NEPTUNE USED IS UNK. THE ACCOUNT DID NOT NOTIFY THE MFR WHEN THIS EVENT OCCURRED BECAUSE THE DEVICE DID NOT MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEPTUNE 2 ROVER ULTRA (120V) AIR-HANDLING APPARATUS FOR A SURGICAL OPERATING ROOM FYD STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death