BEUDAMED
    FDA Adverse Event Summary report: N

    SPECTRA OPTIA

    MDR report key: 3306621 · Received August 26, 2013

    Report

    Report Number
    1722028-2013-01364
    Date Received
    August 26, 2013
    Date of Event
    July 2, 2013
    Report Date
    July 29, 2013
    Manufacturer
    TERUMO BCT
    Product Code
    LKN
    PMA / PMN Number
    BK120012
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: TERUMO BCT (B)(4), INC. HAS CONFIRMED THE CUSTOMER¿S STATEMENT AND FOUND THE FOLLOWING:THERE WAS A SHAVED-OFF PART AND LEAK POINT ON THE UPPER SIDE OF THE CHANNEL BELT NEAR THE INLET PORT ON THE CHANNEL. THERE WAS A STRESS LINE ON THE CHANNEL BELT OF THE CHANNEL. THE DISPOSABLE SET WAS RETURNED TO (B)(4) FOR INVESTIGATION. THE CHANNEL AND LOOP SECTION WAS RECEIVED. THE OBSERVATIONS WERE THE SAME AS TERUMO BCT (B)(4). A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THIS UNIT SHOWED NO EVENTS THAT WOULD HAVE CONTRIBUTED TO THE LEAK THAT WAS EXPERIENCED BY THE CUSTOMER. ROOT CAUSE: THE MARKINGS ON THE CHANNEL ARE CONSISTENT WITH A DISPOSABLE MISLOAD BY THE OPERATOR. THE CHANNEL WAS NOT SEATED FULLY INTO THE FILLER AND MOVED UPWARD DURING THE RUN. THE FORCE PULLED THE CHANNEL OVER THE EDGE OF THE FILLER, CAUSING A CREASE MARK. IT EVENTUALLY PULLED UPWARD HIGH ENOUGH AT THE INLET CONNECTOR END THAT IT HIT THE ARM AND SHEARED OFF PART OF THE CHANNEL, RESULTING IN A LEAK. CORRECTION: MANUFACTURING STAFF WERE MADE AWARE OF THIS INCIDENT ON (B)(4) 2013.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED TO PROVIDE ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A COLLECTION PROCEDURE, THERE WAS A BLOOD LEAK FROM THE CHANNEL AND THEY WERE UNABLE TO PROCEED DUE TO 'LEAK DETECTED' ALARM. PATIENT INFORMATION 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

    DUE TO (B)(4) PRIVACY LAWS, THE CUSTOMER WAS UNABLE TO PROVIDE ANY IDENTIFYING PATIENTINFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    417929 SPECTRA OPTIA SPECTRA OPTIA COLLECT SET LKN TERUMO BCT 06U3214

    Patients

    Seq Age Sex Outcome Treatment
    1