BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACL 1000

    MDR report key: 3254760 · Received July 2, 2013

    Report

    Report Number
    1217183-2013-00013
    Event Type
    Other
    Date Received
    July 2, 2013
    Date of Event
    June 13, 2013
    Report Date
    June 18, 2013
    Manufacturer
    INSTRUMENTATION LABORATORY CO. (IL)
    Product Code
    JPA
    PMA / PMN Number
    K912087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, 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 IDENTIFIES REAGENTS THAT CONTAIN SODIUM AZIDE. WE ADVISE IN THE MSDSS 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 DIRECTION OF THE FDA), ADVISING OUR COAGULATION SYSTEM CUSTOMERS TO TAKE PRECAUTIONS WHEN DISPOSING OF REAGENTS, ROUTINE DECONTAMINATION OF DRAINS AND ALSO DECONTAMINATION OF PLUMBING CONTAINING SODIUM AZIDE. THIS URGENT SAFETY NOTIFICATION CONTINUES TO BE PROVIDED TO CUSTOMERS WITH ALL NEW INSTRUMENT UNITS. A REMINDER NOTIFICATION WILL BE SENT TO THE FIELD TO REINFORCE THE PREVIOUS URGENT SAFETY NOTIFICATION REGARDING SODIUM AZIDE PRECAUTIONS.

    Description of Event or Problem · 1

    A COMPLAINT CAME IN INVOLVING A SODIUM AZIDE EXPLOSION. THE CUSTOMER REPORTED THAT THEIR ACL 1000 ANALYZER HAD BEEN DRAINING INTO THE SINK FOR THE PAST TEN YEARS. THERE WERE NO INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300647 ACL 1000 COAGULATION ANALYZER JPA INSTRUMENTATION LABORATORY CO. (IL) 9103-16

    Patients

    Seq Age Sex Outcome Treatment
    1