BEUDAMED
    FDA Adverse Event Summary report: N

    SPECTRA OPTIA

    MDR report key: 3232845 · Received July 18, 2013

    Report

    Report Number
    1722028-2013-01285
    Date Received
    July 18, 2013
    Date of Event
    June 6, 2013
    Report Date
    June 19, 2013
    Manufacturer
    TERUMO BCT
    Product Code
    LKN
    PMA / PMN Number
    BK120012
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: THE DISPOSABLE SET WAS RETURNED FOR INVESTIGATION. THE SET WAS VISUALLY INSPECTED. A LEAK ON THE 4-LUMEN INLET TUBING AT THE LOWER LOOP SLEEVE HEX WAS LOCATED. THE INLET TUBE WAS TACKED TO THE TOP OF THE LOOP SLEEVE CAUSING THE TUBE TO TEAR DURING CENTRIFUGATION. ROOT CAUSE: POTENTIAL CAUSE MAY INCLUDE A WEAK POINT ON THE INLET TUBE RELATED TO THE PRESENCE OF SOLVENT. SOLVENT IS APPLIED TO THIS PART IN A CONTROLLED MANNER DURING MANUFACTURING, HOWEVER THE MANNER IN WHICH IT ADHERES TO THE PARTS CAN VARY; THIS CAN POTENTIALLY CAUSE A WEAKNESS IN THE TUBING.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A MONONUCLEAR CELL (MNC) COLLECTION PROCEDURE, THERE WAS A LEAK IN THE CENTRIFUGE. THE PROCEDURE WAS STOPPED AND THE PATIENT WAS DISCONNECTED. THIS REPORT IS BEING FILED IN RESPONSE TO THE CUSTOMER FILING A MEDWATCH REPORT ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333244 SPECTRA OPTIA SPECTRA OPTIA COLLECT SET LKN TERUMO BCT 03V3225

    Patients

    Seq Age Sex Outcome Treatment
    1 00054 YR