BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER ACT DIFF 2 ANALYZER

    MDR report key: 4241736 · Received November 10, 2014

    Report

    Report Number
    1061932-2014-02792
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Date of Event
    October 22, 2014
    Report Date
    October 22, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K990352
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) NOTED THE RED BLOOD CELL (RBC) BATH OVERFLOWING AND VACUUM ERRORS DUE TO WEAKENED DUAL HEAD PUMP OUTPUT. THE FSE REPLACED THE WET VACUUM FLUID BARRIER AND DUAL HEAD PUMP ASSEMBLY TO RESOLVE THE ISSUES. SERVICE ACTIVITY PERFORMED WAS VERIFIED TO MEET THE SPECIFIED REQUIREMENTS PER ESTABLISHED PROCEDURES. RESULTS MET PUBLISHED PERFORMANCE SPECIFICATIONS. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED PERFORMANCE SPECIFICATIONS AND WAS RETURNED TO NORMAL OPERATION. PUMP ASSEMBLY. IN CONCLUSION, THE LIKELY CAUSE OF THE EVENT IS ATTRIBUTED TO THE PNEUMATIC PUMP. A DEFINITIVE ROOT CAUSE IS UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED APPROXIMATELY 20 MILLILITERS OF CLEAR FLUID LEAKED ONTO THE COUNTER INVOLVING THE COULTER ACT DIFF 2 ANALYZER. THE CUSTOMER STATED FLUID WAS COMING FROM THE BOTTOM OF THE INSTRUMENT AND NOTED THE RED BLOOD CELL (RBC) BATH WAS OVERFLOWING; FLUID WAS ALSO IN THE VACUUM ISOLATOR CHAMBER (VIC) AND VACUUM TRAP. THE OPERATOR WAS WEARING PROPER PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES, A LABORATORY COAT, AND EYE GOGGLES AND DID NOT HAVE DIRECT CONTACT WITH THE FLUID. THERE WAS NO OPERATOR INJURY OR ADVERSE EFFECT ASSOCIATED WITH THIS EVENT. PATIENT RESULTS WERE NOT IMPACTED. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT. THE FACILITY HAS AN EXPOSURE CONTROL PLAN IN PLACE FOR BIOHAZARD MATERIAL. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723742 COULTER ACT DIFF 2 ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1