BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRA OPTIA

    MDR report key: 3885024 · Received June 19, 2014

    Report

    Report Number
    1722028-2014-00242
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 22, 2014
    Manufacturer
    TERUMO BCT
    Product Code
    LKN
    PMA / PMN Number
    K071079
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: A TERUMO BCT SERVICE TECHNICIAN SUCCESSFULLY COMPLETED A PREVENTATIVE MAINTENANCE (PM) THE DAY BEFORE THE INCIDENT. THE FOLLOWING DAY, TERUMO BCT SERVICE TECHNICIAN RE-INSPECTED THE PARAMETERS AND REBOOTED THE DEVICE. AN AUTO TEST WAS SUCCESSFULLY PERFORMED. INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: A QUERY OF ALL RUN DATA FILES ON THE NETWORK SHOWED THAT THIS FAILURE WAS THE FIRST OCCURRENCE OF THIS SOFTWARE PROBLEM. THE SERVICE HISTORY OF THIS MACHINE, FOR THE PAST YEAR WAS EVALUATED AND THERE WAS NO PREVIOUS SERVICE THAT COULD REASONABLY CONTRIBUTE TO THE REPORTED CONDITION. ROOT CAUSE: SOFTWARE DEFECT CORRECTION: THIS ISSUE WAS ADDED TO THE INTERNAL ISSUE TRACKING SYSTEM FOR INVESTIGATION OF POSSIBLE FUTURE SOFTWARE REVISIONS. THE DEVICE WAS REPLACED WITH ANOTHER SPECTRA OPTIA.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: PER THE CUSTOMER, AFTER THE COLLECTION OF THE 1ST CHAMBER (WHICH TOOK MORE THAN 4600 ML TBV), THE COLLECTION VALVE WASN¿T CLOSED ¿ PLASMA STILL FLOWED IN TO THE COLLECTION BAG, DILUTING THE PRODUCT. FOR THE SECOND CHAMBER, THE COLLECTION STATUS SCREEN SHOWED PROCESSED TBV STARTING FROM AROUND -4600ML AND COUNTING TOWARD ZERO. THE PROCEDURE WAS TERMINATED AND CONTINUED SUCCESSFULLY ON A DIFFERENT MACHINE. PER THE CUSTOMER, THE AC INFUSION RATE WAS DISPLAYED AS MORE THAN 53, AND AFTER THE PROCEDURE WAS ENDED, THE REPORT SCREEN SHOWED THAT 12 ML OF ACDA WENT TO THE DONOR, WHEN WAS ACTUALLY MORE THAN 500ML OF AC. MOREOVER, TBV CALCULATIONS WERE ALSO NOT CORRECT. PER THE CUSTOMER, THE OPTIA WORKED PROPERLY WITHOUT ANY ISSUES THE PRIOR DAY. THE RUN DATA FILE (RDF) WAS ANALYZED FOR THIS EVENT. RDF REVIEW CONFIRMED THAT THE RUN WAS TERMINATED AND THAT SAFETY NEVER STOPPED MONITORING AS DESIGNED. PER TERUMO BCT I&D, THIS IS A SOFTWARE ANOMALY. THE SYMPTOMS OF THE REPORTED CONDITION WERE REPRODUCED IN-HOUSE. INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING AN ALLOGENEIC MONONUCLEAR CELL (MNC) COLLECTION PROCEDURE,THE TOTAL BLOOD VOLUME PROCESSED READING, AC INFUSION RATE READING, AND THE AC TO DONOR READING BY THE MACHINE WERE INCORRECT. PER EU PERSONAL PRIVACY PROTECTION LAWS, THE PATIENT INFORMATION IS NOT AVAILABLE FROM THE CUSTOMER. THIS REPORT IS BEING FILED DUE TO A DEVICE MALFUNCTION THAT HAS THE POTENTIAL FOR INJURY IF IT WERE TO RECUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362030 SPECTRA OPTIA SPECTRA OPTIA APHERESIS SYSTEM LKN TERUMO BCT 000000000000061000

    Patients

    Seq Age Sex Outcome Treatment
    1 Other