BEUDAMED
    FDA Adverse Event Death Summary report: N

    MVE

    MDR report key: 128153 · Received October 23, 1997

    Report

    Report Number
    60190-1997-90001
    Event Type
    Death
    Date Received
    October 23, 1997
    Date of Event
    October 14, 1997
    Report Date
    October 20, 1997
    Manufacturer
    MVE, INC.
    Product Code
    ECX
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED DUE TO USER ERROR. THE PT WAS IN SURGERY FOR AN EGT PROCEDURE. THE PT WAS BEING ADMINISTERED SUPPLEMENTAL OXYGEN WITH A NASAL CANNULA. THE PT'S BLOOD OXYGEN SATURATION PERCENTAGE CONTINUED TO DECREASE. TO ASSIST IN BOOSTING THE OXYGEN SUPPLY, THE NASAL CANNULA WAS REPLACED WITH AN OXYGEN MASK. THE MASK AND CANNULA RECEIVE OXYGEN FROM THE SAME OXYGEN SUPPLY SYSTEM. EVEN WITH THE OXYGEN MASK, THE PT'S OXYGEN SATURATION PERCENTAGE CONTINUED TO DECREASE. THE PT WAS THEN INTUBATED WITH OXYGEN FROM THE SAME OXYGEN SUPPLY OUTLET. THE INTUBATED OXYGEN RUNS THROUGH AN OXYGEN MONITOR THAT MEASURES THE OXYGEN PERCENTAGE BEING RECEIVED BY THE PT. THE MONITOR READ ZERO OXYGEN. OXYGEN GAS WAS THEN ADMINISTERED TO THE PT WITH A BACKUP EMERGENCY OXYGEN GAS CYLINDER AND REGULATOR. ALL STEPS TAKEN TO REVIVE THE PT FAILED. THE SUPPLY OF OXYGEN FOR THE HOSP COMES FROM AN OXYGEN MANIFOLD SYSTEM ATTACHED TO LIQUID OXYGEN CYLINDERS. AN INDUSTRIAL ARGON LIQUID CYLINDER WAS DELIVERED TO THE HOSP. THE ARGON CYLINDER WAS APPROPRIATELY LABELED IN ACCORDANCE WITH THE DEPT OF TRANSPORATION AND OSHA GUIDELINES. SUPPLEMENTARY LABELING WAS ALSO PRESENT ON THE TOP OF THE ARGON CYLINDER. A CIRCULAR SHAPED LABEL THAT IS BROWN IN COLOR WITH THE WORD "ARGON" WAS ATTACHED TO THE CYLINDER NEXT TO THE VALVE SYTEM. ALSO ALL LINWELD USP MEDICAL LIQUID OXYGEN CYLINDERS INCLUDE A "CERTIFICATE OF ANALYSIS" ATTACHED TO THE TOP OF THE CYLINDER. THE CERTIFICATE INCLUDES THE LOT NUMBER AND THE PURITY OF THE OXYGEN PRODUCT. THIS INFO WAS NOT ON THE ARGON CYLINDER SINCE THE ARGON DELIVERED WAS AN INDUSTRIAL GRADE PRODUCT. EQUIPMENT AND CONTAINERS USED IN OXYGEN SERVICE ARE DESIGNED SO INCOMPATIBLE MATERIALS CANNOT BE MECHANICALLY CONNECTED. THIS SAFETY MECHANISM HAS BEEN IN PLACE FOR MANY YEARS. LINWELD HAS OFFERED SAFETY TRAINING ON THE PROPER USE AND HANDLING OF CYLINDERS TO THE HOSP IN THE PAST. THE HOSP HAS DECLINED SUCH TRAINING. THE HOSP MAINTENANCE PERSON MECHANICALLY REMOVED THE OXYGEN FITTING FROM AN EMPTY OXYGEN CYLINDER, THEN MECHANICALLY REMOVED THE ARGON FITTING FROM THE FULL ARGON CYLINDER AND THEN MECHANICALLY INSTALLED THE OXYGEN FITTING ON AN ARGON CYLINDER. THE ARGON FITTING REMOVED FROM THE ARGON CYLINDER WAS MECHANICALLY ATTACHED TO THE EMPTY OXYGEN CYLINDER. THE OXYGEN CYLINDER WAS THEN MECHANICALLY CONNECTED TO THE OXYGEN SUPPLY SYSTEM USED IN THE HOSP. LINWELD DOES NOT MECHANICALLY HOOK UP CYLINDERS TO AN OXYGEN MANIFOLD SYSTEM. LINWELD ONLY DELIVERS CYLINDERS TO THE STORAGE AREA; HOSP PERSONEEL COMPLETE INSTALLATION. ARGON GAS IS AN INERT GAS THAT CAN CAUSE RAPID SUFFOCATION; THIS INFO IS INCLUDED ON THE WARNING LABEL ATTACHED TO THE ARGON CYLINDER. LINWELD WAS INFORMED BY THE HOSP THAT THE PT WAS BEING ADMINISTERED TO WITH ARGON GAS INSTEAD OF OXYGEN GAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MVE DOT 4L200 CYLINDER ECX MVE, INC. DURA-CYL 180 MP UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death