BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACL 10000

    MDR report key: 3090307 · Received April 17, 2013

    Report

    Report Number
    1217183-2013-00004
    Event Type
    Other
    Date Received
    April 17, 2013
    Date of Event
    April 3, 2013
    Report Date
    April 3, 2013
    Manufacturer
    INSTRUMENTATION LABORATORY (IL) CO.
    Product Code
    JPA
    PMA / PMN Number
    K000053
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INSTRUMENTATION LABORATORY CO HAS TAKEN THE FOLLOWING ACTIONS OVER THE YEARS TO MITIGATE THE RISK OF SODIUM AZIDE EXPLOSIONS: OUR PRODUCT LABELING IDENTIFIED REAGENTS THAT CONTAIN SODIUM AZIDE. WE ADVISE IN THE MSDS'S FOR THESE PRODUCTS THAT THE WASTE SOLUTION SHOULD BE SEPARATED FROM ACIDS AND HEAVY METALS DUE TO EXPLOSION RISK. IN 2009, AN URGENT SAFETY NOTIFICATION WAS ISSUED (UNDER THE DIRECTIONS OF THE FDA), WARNING ALL IL INSTRUMENT USERS OF THE HAZARDS OF SODIUM AZIDE IN THE INSTRUMENT WASTE. THE LETTER ADVISES OUR CUSTOMERS TO TAKE PRECAUTIONS WHEN DISPOSING OF REAGENTS, ROUTINE DECONTAMINATION OF DRAINS AND ALSO DECONTAMINATION OF PLUMBING CONTAINING SODIUM AZIDE. THE LETTER ALSO CONTAINS A "WARNING" STATING THE DECONTAMINATION OF PLUMBING SYSTEM DOES REDUCE THE RISK OF AN EXPLOSION. HOWEVER, A DECONTAMINATED SYSTEM SHOULD BE TREATED WITH RESPECT IN RECOGNITION OF THE POSSIBILITY OF ITS BEING EXPLOSIVE AND MAINTENANCE PEOPLE SHOULD BE ALERTED SO THE PROPER PRECAUTIONS CAN BE TAKEN BEFORE WORKING ON PLUMBING POTENTIALLY CONTAMINATED WITH HEAVY METAL. NOTE: THE URGENT SAFETY NOTIFICATION WAS SENT TO THE CUSTOMER PRIOR TO THE INCIDENT, WHEN THEY REPORTED CORRODED PIPES ON (B)(6) 2013. ISSUE: PER OUR US DISTRIBUTOR (BECKMAN COULTER) AT THE TIME OF THE ABOVE NOTIFICATION IN 2009, THIS CUSTOMER WAS NOT SENT THE URGENT SAFETY NOTIFICATION. THEY ARE CURRENTLY INVESTIGATING THE SITUATION AND WILL PROVIDE AN UPDATE ON THEIR FINDINGS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT WHEN A PLUMBER ATTEMPTED TO DISCONNECT THE WASTE LINE LEADING TO THE DRAIN, THERE WAS AN EXPLOSION INJURING HIM AND SENDING HIM TO THE EMERGENCY ROOM. NO OTHER PERSONNEL WERE INJURED. THE PLUMBER REQUIRED STITCHES IN HIS FINGERS AND HIS HAND WAS BRUISED. NOTE: PRIOR TO THE ABOVE INCIDENT ((B)(6)), THE HOSPITAL NOTIFIED US THAT SODIUM AZIDE HAD CORRODED THE PIPE IN THE SINK THAT WAS DRAINING THE WASTE FROM THEIR ACL 10000 INSTRUMENT. A WASTE CARBOY WAS OVERNIGHTED, SO THAT THEY COULD DRAIN THE WASTE TO THE CARBOY IN ORDER TO CONTINUE TO RUN THE ACL 10000 SYSTEM. A COPY OF AN URGENT SAFETY NOTIFICATION WAS ALSO SENT AT THIS TIME ADVISING THEM OF THE HAZARDS OF SODIUM AZIDE IN THE INSTRUMENT WASTE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165763 ACL 10000 COAGULATION ANALYZER JPA INSTRUMENTATION LABORATORY (IL) CO. 9100-11 NA

    Patients

    Seq Age Sex Outcome Treatment
    1