BEUDAMED
    FDA Adverse Event Other Summary report: N

    SPECTRA OPTIA COLLECT SET

    MDR report key: 2142994 · Received June 21, 2011

    Report

    Report Number
    1722028-2011-00184
    Event Type
    Other
    Date Received
    June 21, 2011
    Date of Event
    March 21, 2011
    Report Date
    May 30, 2011
    Manufacturer
    CARIDIANBCT
    Product Code
    LKN
    PMA / PMN Number
    K103090
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION: UPON VISUAL INSPECTION OF THE DISPOSABLE SET, THE FOLLOWING OBSERVATIONS WERE NOTED: THE UPPER BEARING WAS LACKING A WITNESS MARK TO INDICATE CORRECT LOADING (THE LOWER BEARING DOES HAVE SUCH A MARK). THE UPPER BEARING WAS WORN ADJACENT TO THE BRAID, WHICH CAN OCCUR WHEN THE BEARING IS INCORRECTLY LOADED IN TO THE HOLDER. THE BRAID WAS ALSO WORN ADJACENT TO THE BEARING, A LEAK WAS NOTED UNDER THE 4-LUMEN TUBING AT THIS LOCATION. AN IMAGE SUPPLIED WITH THIS COMPLAINT REPORT SHOWED THE BEARING TO BE IN THE CORRECT POSITION AFTER THE LEAK OCCURRED. UNFORTUNATELY, WE ARE UNABLE TO EXPLAIN THIS OBSERVATION. TRENDS SUGGEST THAT THE EVENT REPORTED IS RANDOM AND OCCURS AT A LOW LEVEL ON A GENERAL BASIS. ROOT CAUSE: BASED ON THE RETURNED DISPOSABLE, THE LOOP FAILURE IS BELIEVED TO HAVE BEEN CAUSED BY THE OPERATOR INCORRECTLY LOADING THE DISPOSABLE.

    Description of Event or Problem · 1

    DURING THE PROCEDURE, WITH ONE HOUR LEFT, THERE WAS AN ALARM FOR A CENTRIFUGE LEAK. THE COLLECTION WAS STOPPED. WHEN THE COVER WAS OPENED, IT WAS NOTED THAT THERE WAS SHEARING AND LEAKING OF A SMALL AMOUNT OF BLOOD IN THE MACHINE. ALSO, THE WEBBING ON THE TUBING WAS FRAYED, BUT NOT TWISTED. THE PATIENT INFORMATION IS UNAVAILABLE AT THIS TIME. PER INFORMATION AVAILABLE TO CARIDIANBCT, NO SAFETY ISSUE OCCURRED. CARIDIANBCT BECAME AWARE THAT THE CUSTOMER REPORTED THIS EVENT TO THEIR LOCAL AUTHORITIES ON (B)(4) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPECTRA OPTIA COLLECT SET SEPARATOR, AUTOMATED, BLOOD CELL AND PL LKN CARIDIANBCT 12S3114

    Patients

    Seq Age Sex Outcome Treatment
    1 Other