BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCHITECT C8000 SYSTEM

    MDR report key: 3942175 · Received July 17, 2014

    Report

    Report Number
    1628664-2014-00141
    Event Type
    Injury
    Date Received
    July 17, 2014
    Date of Event
    June 25, 2014
    Report Date
    June 25, 2014
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    PMA / PMN Number
    K980367
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS PROVIDED ON SEPTEMBER 11, 2014 REGARDING THE CURRENT STATE OF THE LABORATORY EMPLOYEE THAT SLIPPED AND FELL DUE TO WATER UNDERNEATH THE ARCHITECT C8000 ANALYER. THE EMPLOYEE WAS GIVEN 3 DAYS DISABILITY REST BY THE ACCOUNT'S OCCUPATIONAL RISK INSURANCE DEPARTMENT DUE TO HIS SPRAINED KNEE. THE EMPLOYEE RETURNED TO NORMAL WORK DUTIES AFTER THE 3 DAYS. THE INJURY HAS HEALED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER WAS UNABLE TO IDENTIFY THE SOURCE OF THE WATER AND FIELD SERVICE WAS DISPATCHED. AN ABBOTT FIELD SERVICE ENGINEER (FSE) INSPECTED THE ANALYZER AND IDENTIFIED THAT THE TOP BELLOWS PUMP ELBOW FITTING (PART NUMBER 2-89191-02) FOR THE PROBE WASH PUMP WAS LOOSE AND LEAKING WATER. THE FSE TIGHTENED THE EXISTING ELBOW FITTING CONNECTION TO RESOLVE THE LEAKING. THE CAUSE OF THE LOOSE ELBOW FITTING CONNECTION COULD NOT BE DETERMINED. THE ELBOW FITTINGS ARE REMOVED WHEN THE CUSTOMER OR FSE PERFORMS MAINTENANCE OR TROUBLESHOOTING INVOLVING THE BELLOWS PUMP. NEITHER THE FSE NOR THE CUSTOMER HAD RECENTLY PERFORMED DOCUMENTED MAINTENANCE INVOLVING THE ELBOW FITTING CONNECTIONS. HOWEVER, A SERVICE TICKET OPENED TWO DAYS EARLIER INVOLVED VERIFICATION OF FLUIDIC COMPONENTS INCLUDING THE SYRINGES, CHECK VALVES, AND WASH CUPS AND VERIFICATION OF THE REAGENT AND SAMPLE PROBE CALIBRATIONS. NO ADVERSE TRENDS OR PRODUCT ISSUES WERE IDENTIFIED IN A 12 MONTH REVIEW OF BELLOWS PUMP ELBOW FITTING COMPLAINTS AND TRENDING DATA. THE CURRENT COMPLAINT IS THE SOLE TICKET DOCUMENTING A SLIP/FALL INJURY SUSTAINED DUE TO A LEAKING BELLOWS PUMP ELBOW FITTING OVER A THREE YEAR REVIEW PERIOD. THE ARCHITECT SYSTEM OPERATIONS MANUAL PROVIDES ADEQUATE LABELING WITH REGARD TO MAINTENANCE, COMPONENT REPLACEMENT, AND TROUBLESHOOTING THE REPORTED ISSUE. SECTION 9 STATES THE USER MAY NEED TO REPLACE CERTAIN SUPPLY AND PUMP COMPONENTS DUE TO NORMAL WEAR FROM DAILY OPERATIONS. INSTRUCTIONS INCLUDE REMOVING THE TOP OR SIDE ELBOW FITTING SECURING THE TUBING TO THE PUMP CONNECTION. WHEN REATTACHING THE ELBOW FITTING, THE USER IS INSTRUCTED TO FINGER-TIGHTEN THE FITTING AT THE PUMP CONNECTION. THERE IS INSUFFICIENT INFORMATION TO CONCLUDE A MALFUNCTION DID NOT OCCUR. THE CAUSE OF THE LOOSE ELBOW FITTING CONNECTION COULD NOT BE DETERMINED. THERE IS NO INDICATION OF A DEFICIENCY OF BELLOWS PUMP ELBOW FITTING, PART NUMBER 2-89191-02. THE EXISTING FITTING CONNECTION WAS TIGHTENED CORRECTLY AND REMAINS IN USE ON THE INSTRUMENT.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT SHE SAW WATER ON THE FLOOR UNDERNEATH THE LEFT SIDE OF THE ARCHITECT C8000 INSTRUMENT ON (B)(6) 2014. SHE WAS UNABLE TO IDENTIFY THE SOURCE OF THE WATER. SHE STATED THAT A LABORATORY EMPLOYEE FELL DUE TO THE WATER ON THE FLOOR. AN ABBOTT FIELD SERVICE ENGINEER INSPECTED THE C8000 ANALYZER AND REPAIRED A LEAK FROM A LOOSE PUMP FITTING. THE CUSTOMER WAS UNSURE HOW THE FITTING BECAME LOOSE. THE CUSTOMER STATED THAT THE EMPLOYEE WHO FELL WAS DIAGNOSED WITH A SPRAINED KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419585 ARCHITECT C8000 SYSTEM AUTOMATED CHEMISTRY ANALYZER JJE ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability