BEUDAMED
    FDA Adverse Event Summary report: N

    SPECTRA OPTIA

    MDR report key: 2962460 · Received February 14, 2013

    Report

    Report Number
    1722028-2013-00939
    Date Received
    February 14, 2013
    Date of Event
    January 14, 2013
    Report Date
    January 16, 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: AN OPTIA SET WAS RETURNED FOR INVESTIGATION. UPON VISUAL INSPECTION OF THE SET,THE FOLLOWING OBSERVATIONS WERE NOTED:-THE UPPER AND LOWER BEARINGS HAD WITNESS MARKS TO SUGGEST CORRECT LOADING BY THE CUSTOMER- A SMALL 1MM TEAR WAS NOTED AT THE TOP OF THE INLET LINE ADJACENT TO THE LOWER HEX (LEAK WAS VERIFIED FROM THIS POINT UNDER PRESSURIZED AIR)-GLUE WAS PRESENT ON THE INLET LINE TO THE TOP OF THE HEX SLEEVE. ROOT CAUSE: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. POTENTIAL CAUSES INCLUDE (BUT ARE NOT LIMITED TO):-A WEAK POINT ON THE TUBE RELATED TO THE PRESENCE OF SOLVENT-STRESSES PUT ON THE DISPOSABLE DURING LOADING OR UNLOADING A REVIEW OF THE LOT FOR SIMILAR REPORTS WAS CARRIED OUT, NONE HAVE BEEN REPORTED.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THIS UNIT SHOWED NO IRREGULARITIES DURING MANUFACTURING THAT WERE RELEVANT TO THIS ISSUE.

    Description of Event or Problem · 1

    NO MEDICAL INTERVENTION WAS REQUIRED FOR THIS EVENT. THE CUSTOMER DECLINED REQUESTS TO PROVIDE ANY FURTHER PATIENT INFORMATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A MONONUCLEAR CELL COLLECTION PROCEDURE, THEY RECEIVED AN ALARM MESSAGE, 'LEAK DETECTED IN CENTRIFUGE'. THE PROCEDURE WAS STOPPED AND THE PATIENT WAS DISCONNECTED. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66023 SPECTRA OPTIA SPECTRA OPTIA COLLECT SET LKN TERUMO BCT 10U3113

    Patients

    Seq Age Sex Outcome Treatment
    1