BEUDAMED
    FDA Adverse Event Summary report: N

    SPECTRA OPTIA

    MDR report key: 3232858 · Received July 18, 2013

    Report

    Report Number
    1722028-2013-01287
    Date Received
    July 18, 2013
    Date of Event
    June 19, 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. THE SOLVENT WAS WITHIN SPECIFICATION. A LEAK WAS LOCATED ON THE INLET TUBING AT THE TOP OF THE LOWER LOOP SLEEVE. INVESTIGATION EVALUATION AND CORRECTIVE ACTIONS ARE IN-PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THIS UNIT SHOWED NO IRREGULARITIES DURING MANUFACTURING THAT WERE RELEVANT TO THIS ISSUE. THE MANUFACTURING PROCESS WAS EVALUATED. THE SETS PRODUCED ON THIS LOT MET ALL ACCEPTANCE CRITERIA FOR RELEASE. THE MAINTENANCE RECORDS WERE EVALUATED. THERE WERE NO PREVENTIVE MAINTENANCE OR REPAIR REPORTS RELATED TO SOLVENT DISPENSING FOR THE ENTIRE MONTH IN WHICH THIS LOT WAS BUILT. THE 4 LUMEN TUBING WAS INVESTIGATED. RECEIVING INSPECTION RESULTS SHOWED THAT THE TUBING WALL THICKNESS HAS BEEN NOMINAL OR ON THE HIGHER SIDE OF THE SPECIFICATION. THE SUPPLIER'S EXTRUSION PROCESS WAS EVALUATED. THERE HAVE BEEN NO CHANGES TO THE MATERIAL OR THE PROCESS AND PROPER PROCEDURES FOR MATERIAL PROCESSING HAVE BEEN FOLLOWED. LIFE TESTING OF THE LOOP AND CHANNEL COULD NOT PRODUCE SIMILAR RESULTS EXPERIENCED BY THE CUSTOMER. ROOT CAUSE: A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED AT THIS TIME. BASED ON THE TESTING, EVALUATION OF THE PROCESS, MATERIALS, AND THE RETURNED PARTS, IT IS LIKELY THAT TOO MUCH SOLVENT WAS DISPENSED INTO THE LOOP SLEEVE, WHICH IN TURN WEAKENED THE TUBING AND OVER THE COURSE OF THE PROCEDURE CAUSED A PREMATURE FAILURE OF THE LOOP. CORRECTION: ALL OF THE PRODUCTION ASSOCIATES HAVE BEEN RETRAINED TO THE LOOP ASSEMBLY PROCEDURE WITH SPECIFIC ATTENTION PAID TO THE SOLVENT DISPENSING METHODOLOGY. IN ADDITION, THE PREVENTIVE MAINTENANCE DOCUMENT FOR THE LOOP DRYER HAS BEEN UPDATED TO INCLUDE THE SOLVENT DISPENSING PUMP PARAMETERS TO HELP SIMPLIFY THE MAINTENANCE ACTIVITIES.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING THE LAST 20 MINUTE OF A MONONUCLEAR CELL COLLECTION (MNC)PROCEDURE, THERE WAS A LEAK AT THE 4-LUMEN TUBING BY THE LOWER BEARING HOLDER. 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
    335119 SPECTRA OPTIA SPECTRA OPTIA COLLECT SET LKN TERUMO BCT 03V3225

    Patients

    Seq Age Sex Outcome Treatment
    1