BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREMIER NITROSPRAY PLUS LITE

    MDR report key: 1963705 · Received December 21, 2010

    Report

    Report Number
    2511556-2010-00004
    Event Type
    Malfunction
    Date Received
    December 21, 2010
    Date of Event
    November 29, 2010
    Report Date
    November 29, 2010
    Manufacturer
    PREMIER MEDICAL MANUFACTURING
    Product Code
    GEH
    PMA / PMN Number
    K970992
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PREMIER RECEIVED THE UNIT BACK FROM THE HOSPITAL, INSPECTED, AND TESTED THE UNIT USING AIR PRESSURE. THE UNIT WAS TESTED AS IT WAS RETURNED BY THE HOSPITAL WITH THE SPRAY NOZZLE ASSEMBLY LOOSENED AND ROTATED 180 DEGREES FROM ITS FIXED POSITION HOLDING THE PRESSURE RELIEF VALVE CLOSED. THIS PREVENTED THE AIR FROM ESCAPING AND THE UNIT HELD THE AIR PRESSURE INTRODUCED INTO THE CANISTER. THIS UNIT WOULD HAVE CONTINUED TO BUILD PRESSURE IF IT WOULD HAVE BEEN FILLED AND TESTED WITH LN2. WE FOUND THE PRESSURE RELIEF VALVE WORKING NORMALLY WHEN NOT PURPOSELY HELD CLOSED. THE DOCTOR SAID "IT HAS BEEN USED SUCCESSFULLY WITHOUT INCIDENT UP UNTIL NOW." THE SPRAY NOZZLE IS INSTALLED AND TIGHTENED WITH A WRENCH 180 DEGREES IN THE OPPOSITE DIRECTION FROM THE PRESSURE RELIEF VALVE. THIS INCIDENT WOULD NOT HAVE OCCURRED IF THE PRESSURE RELIEF VALVE WAS NOT BLOCKED PREVENTING IT FROM PERFORMING ITS INTENDED CRITICAL FUNCTION OF RELEASING PRESSURE GREATER THAN OR EQUAL TO 6 PSI. BLOCKING THE PRESSURE RELIEF VALVE ULTIMATELY ALLOWED THE UNIT TO BUILD EXCESSIVE PRESSURE AND EVENTUALLY LED TO THE LID BLOWING OFF. THERE HAVE BEEN NO OTHER REPORTED COMPLAINTS REGARDING THIS TYPE OF PROBLEM. THE UNIT IS USED BY A TRAINED PROFESSIONAL MINIMIZING RISK TO THE USER AND PATIENT. THE PRODUCT LABELING ALSO INCLUDES CAUTION STATEMENTS TO NOT TAMPER OR BLOCK THE PRESSURE RELIEF VALVE AND TO NOT USE THE SPRAY NOZZLE AS A LEVER FURTHER MITIGATING RISK TO THE USER AND PATIENT.

    Description of Event or Problem · 1

    A NITROSPRAY PLUS LITE CRYOGEN CANISTER CONTAINING LN2 WAS LEFT SITTING ON A NORTH FACING WINDOW SILL WHEN IT EXPLODED, THE LID BLEW OFF AND HIT THE CEILING WITH THE DOCTOR IN THE ROOM. THE DOCTOR WAS STANDING 8'-9' FEET AWAY, BUT NO ONE ELSE WAS IN THE ROOM AT THE TIME. THE DOCTOR REPORTED "I HAD A RINGING IN MY LEFT EAR AND DECREASED HEARING FOR 1-2 HOURS, BUT THAT'S ALL COME BACK TO NORMAL." "NO ONE ELSE WAS INJURED." THE DOCTOR BELIEVES THE UNIT WAS FILLED WITH LN2 ON (B)(6) 2010. THE UNIT WAS LEFT ON A NORTH FACING WINDOW SILL AFTER BEING FILLED. THE DOCTOR SAID, "IT HAS BEEN USED SUCCESSFULLY AND WITHOUT INCIDENT UP UNTIL NOW." NOTE: THE LN2 EVAPORATES IN 6 HOURS UNDER NORMAL CONDITIONS, BUT FASTER WHEN IN USE. THE DOCTOR REPORTED THE FOLLOWING: "ALTHOUGH I AM UNCERTAIN WHY THIS EVENT HAPPENED, BUT I CAN SPECULATE THAT THE "NOZZLE" WAS BLOCKING THE SAFETY/VENTING VALVE ON THE TOP." "I AM NOT AWARE WHEN/HOW IT WAS PUT INTO THIS POSITION." "IF THE CANISTER WAS FILLED LAST WEEK, BUT UNUSED, NO GAS WOULD HAVE VENTED." "AS THE LIQUID NITROGEN WARMED, THE GAS BUILDUP WOULD HAVE LED TO THE INCREASED PRESSURE AND THE EXPLOSION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PREMIER NITROSPRAY PLUS LITE CRYOGEN DEVICE GEH PREMIER MEDICAL MANUFACTURING

    Patients

    Seq Age Sex Outcome Treatment
    1 Other