BEUDAMED
    FDA Adverse Event Other Summary report: N

    SPECTRA OPTIA EXCHANGE SET

    MDR report key: 2092904 · Received May 5, 2011

    Report

    Report Number
    1722028-2011-00035
    Event Type
    Other
    Date Received
    May 5, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 11, 2011
    Manufacturer
    CARIDIANBCT
    Product Code
    LKN
    PMA / PMN Number
    K071079
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION: UPON VISUAL INSPECTION THE MALE/FEMALE LUER CONNECTION BETWEEN THE CASSETTE AND Y CONNECTOR TO THE REPLACEMENT FLUID SPIKES WAS NO LONGER ATTACHED. DURING TESTING IT WAS POSSIBLE TO RECONNECT THE LUER WITH NO NOTED LOOSENESS. DHR: THERE WERE NO IN-PROCESS FAILURES OR NON-CONFORMITIES THAT ARE RELATED TO THE BONDING OF A BAG. THE LOT MET ALL QUALITY LABS, STERILIZATION, AND RELEASE REQUIREMENTS. ROOT CAUSE: THE CAUSE OF THIS DEFECT MAY BE RELATED TO A MISASSEMBLY, WHERE THE OPERATOR HAS NOT APPLIED A PART CORRECTLY DURING MANUFACTURING. 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

    CARDIANBCT BECAME AWARE OF NEW INFORMATION THAT CHANGED THIS COMPLAINT TO A REPORTABLE EVENT ON (B)(6) 2011. DURING SET-UP, THE STERILE BAG TUBING DISCONNECTED. NO INJURY OCCURRED AS NO PATIENT WAS CONNECTED DURING THE SET-UP PROCESS. NO PATIENT WAS INVOLVED THEREFORE, NO PATIENT INFORMATION IS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPECTRA OPTIA EXCHANGE SET SEPARATOR, AUTOMATED, BLOOD CELL AND P1 LKN CARIDIANBCT 05S3120

    Patients

    Seq Age Sex Outcome Treatment
    1 Other