BEUDAMED
    FDA Adverse Event Summary report: N

    SPECTRA OPTIA

    MDR report key: 3000142 · Received March 12, 2013

    Report

    Report Number
    1722028-2013-01004
    Date Received
    March 12, 2013
    Date of Event
    February 12, 2013
    Report Date
    February 13, 2013
    Manufacturer
    TERUMO BCT
    Product Code
    LKN
    PMA / PMN Number
    BK120012
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: THE DISPOSABLE SET WAS RECEIVED FOR EVALUATION. THE SET WAS VISUALLY INSPECTED. THERE WAS A LEAK AT THE INLET LINE AT THE EXIT OF THE LOWER HEX. NO OBVIOUS MANUFACTURING DEFECTS WERE NOTED. INVESTIGATION EVALUATION AND CORRECTIVE ACTIONS ARE IN-PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED TO PROVIDE INFORMATION INADVERTENTLY OMITTED FROM THE INITIAL REPORT. INVESTIGATION EVALUATION AND CORRECTIVE ACTIONS ARE IN-PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED TO PROVIDE ADDITIONAL INFORMATION. INVESTIGATION: A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THIS UNIT SHOWED NO IRREGULARITIES DURING MANUFACTURING THAT WERE RELEVANT TO THIS ISSUE. ROOT CAUSE: POSSIBLE ROOT CAUSES OF THIS FAILURE, ALTHOUGH NOT DEFINITIVE, CAN BE ATTRIBUTED TO A MISLOAD OF THE SET BY THE OPERATOR PRIOR TO RUNNING THE PROCEDURE, AN INCOMPLETE BOND, OR A BREAKAGE AT A TUBING BOND.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT 181 MINUTES INTO A MONONUCLEAR CELL (MNC) PROCEDURE, THEY RECEIVED THE ALARM, 'LEAK DETECTED IN THE CENTRIFUGE'. THE PROCEDURE WAS STOPPED AND THE PATIENT WAS DISCONNECTED. NO MEDICAL INTERVENTION WAS NECESSARY FOR THIS EVENT. PATIENT IDENTIFIER IS NOT AVAILABLE AT THIS TIME. THIS REPORT IS BEING FILED IN RESPONSE TO THE CUSTOMER FILING A SAE REPORT WITH THEIR LOCAL AUTHORITIES.

    Description of Event or Problem · 1

    THE CUSTOMER DECLINED TO PROVIDE THE PATENT IDENTIFIER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103952 SPECTRA OPTIA SPECTRA OPTIA COLLECT SET LKN TERUMO BCT 10U3113

    Patients

    Seq Age Sex Outcome Treatment
    1 00031 YR