BEUDAMED
    FDA Adverse Event Summary report: N

    SPECTRA OPTIA

    MDR report key: 2771025 · Received October 3, 2012

    Report

    Report Number
    1722028-2012-00779
    Date Received
    October 3, 2012
    Date of Event
    September 7, 2012
    Report Date
    September 7, 2012
    Manufacturer
    TERUMO BCT
    Product Code
    LKN
    PMA / PMN Number
    K113480
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION: THE KIT WAS RETURNED FOR ANALYSIS. UPON INSPECTION, A PINHOLE LEAK AT THE COLLECT CONNECTOR WAS CONFIRMED. THIS PINHOLE LEAK WOULD CAUSE THE CUSTOMER COMPLAINT OF LEAK IN THE CENTRIFUGE CHANNEL. MANUFACTURING RECORD REVIEW: A REVIEW OF THE MANUFACTURING RECORDS WAS CONDUCTED IN RELATION TO THIS FAILURE MODE. FOR THIS DISPOSABLE LOT NUMBER, THERE WERE NO IN-PROCESS NON-CONFORMITIES, NO ENGINEERING CHANGE ORDERS, AND NO IN-PROCESS INSPECTION FAILURES OR OBSERVATIONS RELATED TO THIS FAILURE MODE. THERE WERE NO SIMULATED TESTING OBSERVATIONS OR FAILURES. THE PRODUCT MET ALL ACCEPTANCE CRITERIA FOR RELEASE. ROOT CAUSE: THE ROOT CAUSE FOR THE LEAK IN THE CENTRIFUGE CHANNEL WAS THE PINHOLE FOUND IN THE COLLECT CONNECTOR TUBING. CORRECTIVE/PREVENTIVE ACTION: TERUMO BCT HAS IMPLEMENTED LOT RELEASE TESTING ON THE SPECTRA OPTIA CHANNELS TO REDUCE THE OCCURRENCE OF THIS FAILURE MODE. THIS CORRECTIVE ACTION IS STILL ONGOING AT TERUMO BCT; IT HAS REDUCED BUT NOT ERADICATED THIS FAILURE MODE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A LEAK IN THE CENTRIFUGE AFTER 6 HOURS, DESPITE CORRECT INSTALLATION OF THE SET. PATIENT ID AND AGE ARE NOT AVAILABLE AT THIS TIME. THIS REPORT IS BEING FILED IN RESPONSE TO THE CUSTOMER FILING A SAE REPORT WITH THEIR LOCAL AUTHORITIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPECTRA OPTIA SPECTRA OPTIA COLLECT SET, LKN TERUMO BCT 05U3209

    Patients

    Seq Age Sex Outcome Treatment
    1