BEUDAMED
    FDA Adverse Event Summary report: N

    SPECTRA OPTIA

    MDR report key: 3092669 · Received May 3, 2013

    Report

    Report Number
    1722028-2013-01188
    Date Received
    May 3, 2013
    Date of Event
    April 2, 2013
    Report Date
    April 15, 2013
    Manufacturer
    TERUMO BCT
    Product Code
    LKN
    PMA / PMN Number
    BK870022
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    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. PER THE CUSTOMER, THE PROCEDURE WAS STOPPED AFTER THE LEAK WAS DISCOVERED AND THE PATIENT WAS DISCONNECTED. THE COLLECTION WAS CONTINUED ON A NEW MACHINE. ROOT CAUSE: THIS DISPOSABLE SET WAS UNAVAILABLE FOR SPECIFIC ROOT CAUSE ANALYSIS. THE CUSTOMER REPORTED THAT THE LEAK WAS CAUSED BY THE MISLOADING OF THE KIT.

    Additional Manufacturer Narrative · 1

    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 AND TO CORRECT EVALUATION CONCLUSION CODE FROM (B)(4) TO (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE INCORRECT SET-UP OF THE DISPOSABLE SET CAUSED A BREAK OF THE TUBINGS AND A LEAK OF BIOLOGICAL MATERIAL INTO THE CENTRIFUGE CHAMBER. PATIENT INFORMATION IS NOT AVAILABLE AT THIS TIME. THE DISPOSABLE SET IS NOT AVAILABLE FOR RETURN BECAUSE THE CUSTOMER DISCARDED IT. THIS REPORT IS BEING FILED IN RESPONSE TO THE CUSTOMER FILING A SAE REPORT WITH THEIR LOCAL AUTHORITIES.

    Description of Event or Problem · 1

    PATIENT INFORMATION HAS NOT YET BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193654 SPECTRA OPTIA SPECTRA OPTIA COLLECT SET LKN TERUMO BCT 12U3212

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR