BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRA OPTIA APHERESIS SYSTEM

    MDR report key: 2064813 · Received March 25, 2011

    Report

    Report Number
    1722028-2011-00022
    Event Type
    Malfunction
    Date Received
    March 25, 2011
    Date of Event
    February 24, 2011
    Report Date
    February 24, 2011
    Manufacturer
    CARIDIANBCT
    Product Code
    LKN
    PMA / PMN Number
    K071079
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION EVAL AND CORRECTIVE AND PREVENTATIVE ACTIONS ARE IN-PROCESS. INTERIM INVESTIGATION SHOWS THAT A SECOND ANTICOAGULANT (AC) PROTECTION EXISTS. IT IS DESIGNED TO PROTECT THE SYSTEM AGAINST A TOO LOW AC RATIO CONDITION AND ALSO PROTECTS AGAINST AC DIRECTLY TO THE PT. THE SECOND PROTECTION IS NOT IMPACTED BY THE NEWLY DISCOVERED SOFTWARE ANOMALY, AND SO CONTINUES TO WORK PROPERLY EVEN AFTER A POWER FAILURE DURING THE PROCEDURE. THIS SECOND PROTECTION LIMITS AC DIRECTLY TO THE PT, BUT TRIGGERS AT A SOMEWHAT HIGHER LIMIT OF 2ML OF AC. CARIDIANBCT HAS ALSO FOUND NO INCIDENTS OF THIS FAILURE MODE TO DATE OCCURRING IN THE COMPLAINT DATABASE OR THE CUSTOMER DEVICE RUN DATA FILE (RDF) DATABASE.

    Description of Event or Problem · 1

    DURING AN INTERNAL SOFTWARE R AND D QA SOFTWARE TESTING ON A NEW PROTOCOL, AN ANOMALY WAS FOUND RELATED TO A BACKUP SAFETY PROTECTION THAT ENSURES THAT ANTICOAGULANT (AC) DELIVERED DIRECTLY TO THE PT IS LIMITED TO 0.4 ML IN THE EVENT OF A CONTROL SOFTWARE OR HARDWARE FAILURE. THE DEFECT RENDERS THE PROTECTION INEFFECTIVE IF A POWER FAILURE OCCURS AFTER THE PT IS CONNECTED AND THE PROCEDURE STARTED. THIS DEFECT IS PRESENT IN ALL DEVICE PROTOCOLS AND THEREFORE IS PRESENT IN ALL CUSTOMER MACHINES. SINCE THIS INCIDENT WAS DISCOVERED ON A LAB VERSION OF SOFTWARE WHICH WAS NOT INVOLVED IN A PROCEDURE, THERE IS NO ASSOCIATED PT OR DONOR IDENTIFICATION OR PARTICULAR MACHINE FOR THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPECTRA OPTIA APHERESIS SYSTEM SEPARATOR, AUTOMATED, BLOOD CELL AND P1 LKN CARIDIANBCT

    Patients

    Seq Age Sex Outcome Treatment
    1 Other