BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACL TOP CTS

    MDR report key: 2987291 · Received February 22, 2013

    Report

    Report Number
    1217183-2013-00001
    Event Type
    Other
    Date Received
    February 22, 2013
    Date of Event
    February 12, 2013
    Report Date
    February 13, 2013
    Manufacturer
    INSTRUMENTATION LABORATORY (IL) CO.
    Product Code
    GKP
    PMA / PMN Number
    K073377
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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 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 DIRECTION OF THE FDA), ADVISING OUR ACL TOP 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. NOTE: THE CUSTOMER INVOLVED IN THIS INCIDENT, COMMUNITY MEDICAL CENTER, HAD THE URGENT SAFETY NOTIFICATION POSTED ON THE WALL BY THE DRAIN AREA; IN 2011, THE HEMOSIL RINSE SOLUTION FOR THE ACL TOP FAMILY WAS REFORMULATED TO REMOVE SODIUM AZIDE AS THE PRESERVATIVE AND REPLACE IT WITH METHYLISOTHIAZOLONE (MIT). THIS NEW PRESERVATIVE MITIGATES THE HAZARDS ASSOCIATED WITH THE DISPOSAL OF SODIUM AZIDE INTO DRAINS WITH METAL PLUMBING. NOTE: THE HEMOSIL RINSE SOLUTION WAS TARGETED FOR REFORMULATION AS THE PRIMARY CONTRIBUTOR OF SODIUM AZIDE TO THE ACL TOP FAMILY LIQUID WASTE STREAM. BASED ON THE ABOVE ACTIONS PREVIOUSLY TAKEN AND GOOD LABORATORY PRACTICE, NO ADD'L REMEDIAL ACTION IS INDICATED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT A PIPE EXPLODED AS A PLUMBER WAS WORKING ON A CLOGGED DRAIN. THIS WAS A COMMON PIPE SHARED BY THEIR LABORATORY BREAK-ROOM SINK AND THE WASTE FROM THE ACL TOP INSTRUMENTS. ONE OF THE ACL TOP INSTRUMENTS WAS DAMAGED BY THE EXPLOSION. THE EXPLOSION SEEMS TO BE SOLELY RELATED TO THE PLUMBER'S ACTIVITIES. THE CUSTOMER IS NOW PLUMBING WASTE INTO AN EXTERNAL CONTAINER. NOTE: AN IL FIELD SAFETY ENGINEER WAS ON-SITE AT THE TIME OF THE INCIDENT. INITIALLY, THERE WERE NO REPORTS OF MAJOR INJURIES TO EITHER THE IL FIELD SERVICE ENGINEER OR THE PLUMBER. THE IL FIELD SERVICE ENGINEER HAS SUBSEQUENTLY REPORTED RINGING IN HIS EAR AND BURNING IN HIS CHEST DUE TO INGESTION/INHALATION OF THE WASTE, AND IS UNDER THE CARE OF A PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77256 ACL TOP CTS COAGULATION ANALYZER GKP INSTRUMENTATION LABORATORY (IL) CO. 2800-20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1