BEUDAMED
    FDA Adverse Event Death Summary report: N

    V-VAC SUCTION UNIT

    MDR report key: 2021828 · Received March 11, 2011

    Report

    Report Number
    9610483-2011-00001
    Event Type
    Death
    Date Received
    March 11, 2011
    Date of Event
    November 1, 2010
    Report Date
    December 23, 2010
    Manufacturer
    LAERDAL MEDICAL A.S.
    Product Code
    BTA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LAERDAL MEDICAL A.S. PERSONNEL HAVE MET WITH (B)(6) AMBULANCE TO LEARN ABOUT THEIR USE OF THE V-VAC. THEY STORE THE V-VAC (W/CARTRIDGE, ADAPTER TIP, DOUBLE MALE CONNECTOR, BUT NO CATHETER) IN THE OXYGEN BAG WITHIN THE AMBULANCE AND CHECKED AT THE BEGINNING OF EACH SHIFT. NO SPARE V-VAC CARTRIDGES ARE KEPT IN THE AMBULANCE; THEY ARE ONLY AVAILABLE AFTER EXCHANGE AT THE HOSPITAL. THE AMBULANCE ARE EQUIPPED WITH A PERMANENTLY MOUNTED SUCTION PUMP IN ADDITION TO V-VAC. THE AMBULANCE DO NOT HAVE PORTABLE ELECTRICAL SUCTION UNITS. DURING THE LMAS AND (B)(6) MEETING ON (B)(6) 2010, THE DFU WAS REVIEWED. ACCORDING TO THE AMBULANCE PERSONNEL, THEY WERE NOT FAMILIAR WITH THE DFU NOR ITS CONTENTS. LMAS STATES (B)(6) AMBULANCE NEEDS TO PROVIDE THEIR STAFF WITH MORE TRAINING AND OFFERED TO HELP AND RECOMMENDED THE USE OF THE 985100 V-VAC TRAINING KIT. THE V-VAC HAS A 425ML CARTRIDGE THAT CAN BE REPLACED WITH A NEW CARTRIDGE, WITHIN SECONDS, WITHOUT THE NEED FOR TOOLS. THE V-VAC OPERATED PROPERLY, BUT DUE TO HAVING NO EMPTY REPLACEMENT CARTRIDGES AVAILABLE, IT WAS NOT ABLE TO REMOVE ALL OF THE PATIENT'S FLUIDS. NO PRODUCT CORRECTIVE ACTIONS ARE RECOMMENDED.

    Description of Event or Problem · 1

    LAERDAL MEDICAL A.S. (LMAS) HAS INFORMED LAERDAL MEDICAL CORPORATION OF A SECOND PATIENT INCIDENT FROM (B)(6) INVOLVING A V-VAC MANUAL SUCTION UNIT. SOMETIME IN (B)(6) 2010, AN AMBULANCE CREW FROM (B)(6) AMBULANCE SERVICE OF (B)(6) RESPONDED TO A FEMALE WHO DROWNED HERSELF IN THE BATHTUB. THE CREW PERFORMED CPR AND THE V-VAC WITH CATHETER (NON-LAERDAL, TYPE "ORANGE") WAS USED TO REMOVE LARGE AMOUNTS OF WATER AND STOMACH CONTENTS FROM THE PATIENT'S MOUTH AND UPPER AIRWAY. REPORTEDLY, THE V-VAC DID NOT PROVIDE SUFFICIENT SUCTION. THE PATIENT WAS TRANSFERRED TO AN AMBULANCE WHERE ANOTHER SUCTION PUMP WAS AVAILABLE AND REMOVED A LARGE AMOUNT OF WATER FROM THE LUNGS. THE INTUBATION ATTEMPT WAS GIVEN UP AND PATIENT WAS THEN VENTILATED WITH A BAG-MASK. REPORTEDLY, THE PATIENT WAS DECLARED DEAD UPON ARRIVAL AT THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 V-VAC SUCTION UNIT MANUAL ASPIRATOR BTA LAERDAL MEDICAL A.S. V-VAC

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death