BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 880I SYNCHRON ® ACCESS CLINICAL SYSTEM

    MDR report key: 2944671 · Received February 5, 2013

    Report

    Report Number
    2050012-2013-00079
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Date of Event
    January 9, 2013
    Report Date
    January 9, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K060256 RR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) IS CURRENTLY WORKING WITH A TECHNICAL SUPPORT ENGINEER TO RESOLVE THE ISSUE. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION.

    Description of Event or Problem · 1

    WHILE PERFORMING SERVICE ON THE UNICEL DXC 880I SYNCHRON ACCESS CLINICAL SYSTEM FOR AN UNRELATED ISSUE, THE FIELD SERVICE ENGINEER (FSE) NOTED THAT THE BLOOD UREA NITROGEN (BUN) MODULE ASSEMBLY WOULD NOT STAY IN THE RAISED POSITION. THE FSE INDICATED THAT THE ISSUE WAS CAUSED BY A CUP MODULE LATCH WHICH WAS NOT FUNCTIONING PROPERLY. THE FSE NOTED THAT THE MODULE HAS NOT FALLEN AND THERE WAS NO INJURY REPORTED FOR THIS EVENT. NO ERRONEOUS RESULTS WERE GENERATED AND THERE WAS NO CHANGE TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT.

    Description of Event or Problem · 1

    THE BUN MODULE BRACKETS WERE RETURNED TO BECKMAN COULTER FOR EVALUATION AND WAS RECEIVED ON (B)(6) 2013. THE INVESTIGATORS NOTED THAT THE BRACKETS WOULD CLOSE WHEN A SMALL DOWNWARD PRESSURE WAS APPLIED. FAILURE MODE WAS DETERMINED TO BE A FAULTY BUNM MODULE BRACKETS. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) RESOLVED THE CUSTOMER'S ISSUE BY REPLACING THE SLIDE RAILS (BRACKETS) FOR THE BUNM MODULE. PLEASE SEE MEDWATCH #2050012-2013-00072 FOR THE REPORT OF A SIMILAR EVENT WITH THE SAME CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48556 UNICEL® DXC 880I SYNCHRON ® ACCESS CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1