BEUDAMED
    FDA Adverse Event Other Summary report: N

    HEMOSIL REFERENCE EMULSION

    MDR report key: 756683 · Received November 10, 2005

    Report

    Report Number
    2431530-2005-00001
    Event Type
    Other
    Date Received
    November 10, 2005
    Date of Event
    October 24, 2005
    Report Date
    November 10, 2005
    Manufacturer
    INSTRUMENTATION LABORATORY CO.
    Product Code
    LXG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INSTRUMENTATION LABORATORY CONDUCTED AN INTERNAL REVIEW OF THE LABELED WARNINGS FOR HEMOSIL REFERENCE EMULSION RELATED TO ITS SODIUM AZIDE CONTENT. THE DIRECT PRODUCT LABELING INCLUDES THE FOLLOWING INDICATIONS: THE BOX READS: "SODIUM AZIDE 0.1%, "DO NOT EMPTY INTO DRAINS". BOTH THE BOX AND BOTTLE LABEL READ: "CAUTION: CONTAINS SODIUM AZIDE THAT MAY FORM EXPLOSIVE AZIDES IN METAL PLUMBING. USE PROPER DISPOSAL PROCEDURES." FURTHER, THE PRODUCT'S MATERIAL SAFETY DATA SHEET (MSDS) INCLUDES THE FOLLOWING INDICATIONS: KIT HAZARD CLASSIFICATION (EXCERPT): "DO NOT EMPTY INTO DRAINS." "SPECIAL REQUIRMENTS: KEEP AWAY FROM ACIDS (SODIUM AZIDE REACTS STRONGLY) AND AWAY FROM CONTAMINATION WITH HEAVY METALS. SODIUM AZIDE HAS BEEN REPORTED TO FORM LEAD OR COPPER AZIDE IN LABORATORY PLUMBING THAT MAY EXPLODE ON PERCUSSION. FLUSH DRAINS WITH WATER THOROUGHLY AFTER DISPOSING OF FLUIDS CONTAINING SODIUM AZIDE." THE ABOVE REVIEW DETERMINED THAT THE DIRECT PRODUCT LABELING WAS CORRECT WITH NO NEED FOR MODIFICATION. THERE WAS NO PRODUCT MALFUNCTION INDICATED IN THE INCIDENT AND THE PRODUCT IS APPROPRIATELY LABELED.

    Description of Event or Problem · 1

    PER THE INITIAL CUSTOMER REPORT, A CUSTOMER SERVICE ENGINEER (CSE) WAS WORKING ON THE LABORATORY'S SINK DRAIN AND THERE WAS AN ELECTRICAL SPARK FROM A 24-VOLT WIRE THAT RESULTED IN THE COPPER PIPE EXPLODING. THE CSE WENT TO THE EMERGENCY ROOM FOR STITCHES. TWO TECHNICIANS HAD RINGING IN THEIR EARS FROM THE EXPLOSION. ACCORDING TO THE LABORATORY MANAGER, NO LABORATORY PERSONNEL WERE SERIOUSLY INJURED. HE CONTACTED THE EPA AND THE STATE DEPARTMENT OF NATURAL RESOUCES REGARDING THE CLEAN UP AND STATED THAT THEY HAVE THEIR HAZMAT TEAM DOING THE CLEAN UP. PER FOLLOW-UP COMMUNICATION WITH THE CSE, THE WASTE FROM THE LABORATORY'S ACL COAGULATION ANALYZER HAD BEEN DISCARDED INTO THE DRAINPIPE FOR A CONSIDERABLE LENGTH OF TIME AND AT SOME POINT THE INSTRUMENT TUBING BECAME DISCONNECTED AND FLOODED THE FLOOR. WHEN THE CSE NOTICED THE DRAIN TUBING HANGING LOOSE, HE INSERTED IT IN THE DRAIN TRAP HOLE. HE ATTRIBUTES THE RESULTING EXPLOSION TO THE EXISTING SODIUM AZIDE IN THE DRAIN TRAP THAT REACTED WITH THE COPPER PIPE FOR AN EXTENDED TIME AND PRODUCED DANGEROUS VAPORS. THE WASTE WOULD HAVE INCLUDED HEMOSIL REFERENCE EMULSION, WHICH IS A FLUSH (RINSE) SOLUTION USED ON THE ANALYZER AND CONTAINS SODIUM AZIDE (0.1%).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMOSIL REFERENCE EMULSION FLUSH (RINSE) SOLUTION LXG INSTRUMENTATION LABORATORY CO. NA N1242147

    Patients

    Seq Age Sex Outcome Treatment
    1