BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON CX3 DELTA

    MDR report key: 2437365 · Received February 2, 2012

    Report

    Report Number
    2050012-2012-00367
    Event Type
    Malfunction
    Date Received
    February 2, 2012
    Date of Event
    January 11, 2012
    Report Date
    January 11, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJF
    PMA / PMN Number
    K942676
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BECKMAN COULTER IDENTIFIER FOR THIS REPORT IS (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2012, CUSTOMER REPORTED THAT THE GLUCOSE 3 (GLU3) AND CREATININE 3 (CRE3) CUPS WERE OVERFLOWING ON THE CX3 DELTA INSTRUMENT. NO INJURIES WERE REPORTED AND NO ERRONEOUS PATIENT RESULTS WERE GENERATED. FIELD SERVICE ENGINEER (FSE) EXAMINED THE INSTRUMENT AND CHECKED THE DRAIN TUBING. FSE PRIMED THE INSTRUMENT AND THE INITIAL PRIMES DRAINED PROPERLY, BUT AFTER A FEW PRIMES THE CUPS BEGAN OVERFILLING. FSE ALSO FOUND HOLES IN THE C-ARM PINCH TUBING. FSE REPLACED THE PERI-PUMP AND PINCH TUBING. REPAIRS WERE VERIFIED PER ESTABLISHED PROCEDURES. THIS RESOLVED THE ISSUE AND NO FURTHER LEAKS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON CX3 DELTA ANALYZER, CHEMISTRY, MICRO, FOR CLINICAL USE JJF BECKMAN COULTER, INC. CX3 DELTA

    Patients

    Seq Age Sex Outcome Treatment
    1