BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® AC.T DIFF ANALYZER

    MDR report key: 2401117 · Received January 6, 2012

    Report

    Report Number
    1061932-2012-00012
    Event Type
    Malfunction
    Date Received
    January 6, 2012
    Date of Event
    December 6, 2011
    Report Date
    December 6, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    GKZ
    PMA / PMN Number
    K973634
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BEC INTERNAL IDENTIFICATION NUMBER IS (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER INC (BEC) TO REPORT AN ONGOING BACKGROUND ISSUE AND A CLEAR LEAK ON THE BOTTOM RIGHT SIDE OF THE ACT DIFF INSTRUMENT. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF A LAB COAT AND GLOVES. PATIENT RESULTS WERE NOT IMPACTED BY THIS EVENT. THE CUSTOMER DID NOT COME IN CONTACT WITH THE FLUID AND DID NOT SEEK MEDICAL ATTENTION. NO EXPOSURE (SPRAYED OR SPLASHED) TO MUCOUS MEMBRANES OR OPEN WOUNDS WERE REPORTED. NO DEATH, INJURY OR CHANGES TO PATIENT TREATMENT ATTRIBUTED ARE ASSOCIATED WITH THIS EVENT. ON THE DAY OF THE EVENT A FIELD SERVICE ENGINEER (FSE) PERFORMED THE FOLLOWING: DECONTAMINATED THE INSTRUMENT, REPLACED THE AIR FILTERS, THE WASTE & DILUENT PERISTALTIC TUBING, VIC (VACUUM ISOLATION CHAMBER), RINSE BLOCK (PROBE WIPE), HGB LAMP, MIXING / CHECK VALVES AND PINCH TUBING LOCATED AT PINCH VALVES LV14 & LV15. THE VL14 AND VL15 ROUTES WASTE OUT OF THE INSTRUMENT TO THE DRAIN OR WASTE RECEPTACLE. FOUND A CLOG IN PINCH TUBING IN PINCH VALVE LV15, WHICH CAUSED THE BATHS TO OVERFLOW. RAN CLOT DETECTION, ADJUSTED VALVES AND HGB LAMP OUTPUT TO 3692, RAN QC ADJUSTED CALIBRATION FACTORS. RERAN QC TO VERIFY RECOVERY AND PERFORMED A REPRODUCIBILITY TEST TO VERIFY REPAIR. SYSTEM VALIDATED. THE ROOT CAUSE FOR THE LEAK WAS A CLOG IN THE WASTE TUBING AT PINCH VALVE LV15; THE BACKGROUND ISSUE WAS RESOLVED BY INSTRUMENT DECONTAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® AC.T DIFF ANALYZER COUNTER, DIFFERENTIAL CELL, GKZ BECKMAN COULTER INC. ACT DIFF N/A

    Patients

    Seq Age Sex Outcome Treatment
    1