BEUDAMED
    FDA Adverse Event Other Summary report: N

    SPECTRA OPTIA EXCHANGE SET

    MDR report key: 2092907 · Received May 5, 2011

    Report

    Report Number
    1722028-2011-00036
    Event Type
    Other
    Date Received
    May 5, 2011
    Date of Event
    February 7, 2011
    Report Date
    February 11, 2011
    Manufacturer
    CARIDIANBCT
    Product Code
    LKN
    PMA / PMN Number
    K071079
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION: THE OPTIA SET WAS RETURNED FOR INVESTIGATION. A KINK/FOLD IN THE INLET LINE ADJACENT TO THE INLET PORT OF THE CHANNEL WAS NOTED (LOCATED 2CM FROM THE CHANNEL). THE DEVICE HISTORY RECORD WAS REVIEWED. THERE WERE NO ISSUES RELATED TO THIS EVENT. ROOT CAUSE: THE COMMON CAUSES OF TUBING KINKS, INDENTATIONS AND COMPRESSIONS ARE TYPICALLY RELATED TO SLIGHT VARIATIONS DURING TRAY PACKING. CONTENTS SHIFTING MAY ALSO OCCUR DURING PACKAGING AND TRANSPORT TO STERILIZATION. FOLLOWING EXPOSURE TO THE HEAT AND HUMIDITY OF THE STERILIZATION CYCLE, THE TUBING MAY ASSUME A DEFORMED SHAPE. THIS MDR IS BEING FILED IN RESPONSE TO THE CUSTOMER FILING WITH THEIR LOCAL AUTHORITIES. NO SAFETY ISSUE OCCURRED.

    Description of Event or Problem · 1

    CARIDIANBCT BECAME AWARE OF NEW INFO THAT CHANGED THIS COMPLAINT TO A REPORTABLE EVENT ON (B)(4) 2011. DURING THE SET-UP, KINKED TUBING WAS FOUND IN THE CENTRIFUGE LINE. THE ISSUE OCCURRED DURING THE SET UP OF THE DISPOSABLE SET, SO NO PT WAS INVOLVED, AND NO INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPECTRA OPTIA EXCHANGE SET SEPARATOR, AUTOMATED, BLOOD CELL AND PL LKN CARIDIANBCT 09S3313

    Patients

    Seq Age Sex Outcome Treatment
    1 Other