BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACL TOP CTS

    MDR report key: 1038770 · Received May 2, 2008

    Report

    Report Number
    1217183-2008-00002
    Event Type
    Other
    Date Received
    May 2, 2008
    Date of Event
    April 3, 2008
    Report Date
    May 2, 2008
    Manufacturer
    INSTRUMENTATION LABORATORY CO.
    Product Code
    GKP
    PMA / PMN Number
    K063679
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACL TOP WASTE SOLUTION INCLUDES HEMOSIL RINSE SOLUTION, WHICH CONTAINS SODIUM AZIDE. THEREFORE, ACCORDING TO THE IL MSDS SHEET FOR THE RINSE SOLUTION, THE WASTE SOLUTIONS SHOULD BE SEPARATED FROM ACIDS AND HEAVY METALS BECAUSE OF RISK FOR EXPLOSION. THE DIRECT PRODUCT LABELING FOR THE RINSE SOLUTION INCUDES THE FOLLOWING INDICATIONS: THE BOTTLE READS: "LESS THAN 0.1% OF SODIUM AZIDE", "DO NOT EMPTY INTO DRAINS." "CAUTION: CONTAINS SODIUM AZIDE. USE PROPER DISPOSAL PROCEDURE." THE PRODUCT'S MATERIAL SAFETY DATA SHEET (MSDS) INCLUDES THE FOLLOWING INDICATIONS: KIT HAZARD CLASSIFICATION (EXCERPT): "DO NOT EMPTY INTO DRAINS." "SPECIAL REQUIREMENTS: 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 WHICH MAY EXPLODE ON PERCUSSION. DO NOT EMPTY INTO DRAINS. BASED ON THE REVIEW AND GOOD LABORATORY PRACTICE, THE PRODUCT LABELING IS CORRECT, WITH NO REMEDIAL ACTION REQUIRED.

    Description of Event or Problem · 1

    PER THE CUSTOMER COMPLAINT, THE LABORATORY EMPLOYEE WAS MOVING THE ACL TOP AND THERE WAS AN EXPLOSION IN THE DRAIN USED BY INSTRUMENT. ACCORDING TO THE REPORT OF THE ONSITE CUSTOMER SERVICE ENGINEER (CSE), THE EXPLOSION OCCURRED WHEN THE EMPLOYEE TRIED TO REMOVE THE WASTE TUBE FROM THE DRAIN. A PIECE OF THE PVC DRAINPIPE WAS STUCK UNDER HIS CHIN REQUIRING STITCHES AND HE SUFFERED ABRASIONS ON HIS NOSE AND RIGHT ELBOW. HE WENT DIRECTLY TO THE ER TO BE TREATED. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACL TOP CTS COAGULATION INSTRUMENT GKP INSTRUMENTATION LABORATORY CO. TOP CTS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA