BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACL TOP 500 CTS

    MDR report key: 2703812 · Received August 8, 2012

    Report

    Report Number
    1217183-2012-00011
    Event Type
    Other
    Date Received
    August 8, 2012
    Date of Event
    July 10, 2012
    Report Date
    August 8, 2012
    Manufacturer
    INSTRUMENTATION LABORATORY
    Product Code
    GKP
    PMA / PMN Number
    073377
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IN (B)(4) 2009, A CUSTOMER NOTIFICATION WAS SENT BY OUR DISTRIBUTOR ((B)(4)) TO ALL ACL TOP CUSTOMERS STATING THE PRECAUTIONS THAT SHOULD BE TAKEN WHEN DISPOSING OF REAGENTS, ROUTINE DECONTAMINATION OF DRAINS, AND ALSO DECONTAMINATION OF PLUMBING CONTAINING EXPLOSIVE AZIDES. ALSO INCLUDED WITH THIS NOTIFICATION WERE SUGGESTIONS FOR A WARNING TAG TO BE PLACED ON "...YOUR PLUMBING IN A PROMINENT LOCATION..." AS A REMINDER OF PROPER DISPOSAL OF REAGENT WASTE. THIS FDA NOTIFIED RECALL ACTION WAS CLOSED WITH 100% CUSTOMER NOTIFICATION BY OUR DISTRIBUTOR. FURTHER, ACCORDING TO THE (B)(6), THE WASTE SOLUTION SHOULD BE SEPARATED FROM ACIDS AND HEAVY METALS BECAUSE OF RISK FOR EXPLOSION. THE 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 PERCUSSIONS. DO NOT EMPTY INTO DRAINS. THE PRODUCT IS ALSO LABELED: CONTENTS: SURFACTANT AND LESS THAN 0.1% OF SODIUM AZIDE. AVOID CONTACT WITH SKIN AND EYES (S24/25). DO NOT EMPTY INTO DRAINS (S 29). CAUTION: CONTAINS SODIUM AZIDE. USE PROPER DISPOSAL PROCEDURE. BASED ON THE REVIEW AND GOOD LABORATORY PRACTICES, THE PRODUCT LABELING IS CORRECT, WITH NO REMEDIAL ACTION REQUIRED.

    Description of Event or Problem · 1

    THE HOSPITAL HAD THE LIQUID WASTE FROM THEIR ACL TOP 500 CTS INSTRUMENT BEING FED INTO THE MAIN HOSPITAL PLUMBING. A PLUMBER REPLACING COPPER WASTE PIPES WAS INJURED WHEN THE PIPE EXPLODED. HE BADLY INJURED HIS HAND, REQUIRING TWO SURGERIES AND WAS SUBSEQUENTLY DISCHARGED FROM THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACL TOP 500 CTS COAGULATION INSTRUMENT GKP INSTRUMENTATION LABORATORY ACL TOP 500 CTS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other