BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACL 1000

    MDR report key: 2338411 · Received November 9, 2011

    Report

    Report Number
    1217183-2011-00090
    Event Type
    Other
    Date Received
    November 9, 2011
    Date of Event
    October 20, 2011
    Report Date
    November 7, 2011
    Manufacturer
    INSTRUMENTATION LABORATORY CO.
    Product Code
    JPA
    PMA / PMN Number
    K912087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER STATED THAT THEY ARE CURRENTLY USING THE SINK TO DRAIN THE WASTE COMING FROM THE ACL INSTRUMENT AND OTHER HEMATOLOGY ANALYZERS (ACT 5 DIFF AND HMX). ONCE A WEEK, THEY DRAIN THE WASTE FROM THE ACL WASTE CONTAINER INTO THE SINK AND, FOLLOW BY FLUSHING COPIOUS AMOUNT OF WATER (OPEN THE WATER FOR AT LEAST 15 MINUTES). ACCORDING TO THE (B)(6) MSDS, THE WASTE SOLUTIONS 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. OUR DISTRIBUTOR, BECKMAN COULTER, STATES THAT THEY ARE IN RECEIPT OF THE SIGNED CUSTOMER CORRECTIVE ACTION RESPONSE FROM RELATING TO SODIUM AZIDE AND THE ACL COAGULATION ANALYZERS. BASED ON THE REVIEW AND GOOD LABORATORY PRACTICE, THE PRODUCT LABELING IS CORRECT, WITH NO REMEDIAL ACTION REQUIRED.

    Description of Event or Problem · 1

    CUSTOMER STATED THEY HAD THEIR FACILITIES DEPT ON SITE TO FIX A LEAK IN THE PLUMBING. THERE WAS AN EXPLOSION AS THEY WERE CHANGING THE PIPES. THE PERSON CHANGING THE PIPES GOT HURT AND HAD TO BE ATTENDED BY A SPECIALISTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACL 1000 COAGULATION INSTRUMENT JPA INSTRUMENTATION LABORATORY CO. ACL 1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1