BEUDAMED
    FDA Adverse Event Summary report: N

    SPECTRA OPTIA

    MDR report key: 3201179 · Received July 2, 2013

    Report

    Report Number
    1722028-2013-01274
    Date Received
    July 2, 2013
    Date of Event
    June 6, 2013
    Report Date
    June 7, 2013
    Manufacturer
    TERUMO BCT
    Product Code
    LKN
    PMA / PMN Number
    BK120012
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: THE LOOP AND CHANNEL FROM AN OPTIA SET WERE RETURNED FOR INVESTIGATION. UPON VISUAL INSPECTION OF THE SET, THE FOLLOWING OBSERVATIONS WERE NOTED:-THE UPPER AND LOWER BEARINGS HAD WITNESS MARKS TO SUGGEST CORRECT LOADING BY THE CUSTOMER- A SMALL PINHOLE TEAR WAS NOTED AT THE TOP OF THE INLET LINE ADJACENT TO THE LOWER HEX (LEAK WAS VERIFIED FROM THIS POINT UNDER PRESSURIZED AIR)-GLUE WAS PRESENT ON THE INLET LINE TO THE TOP OF THE HEX SLEEVE INVESTIGATION EVALUATION AND CORRECTIVE ACTIONS ARE IN-PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: THE DEVICE HISTORY RECORDS (DHR) WERE REVIEWED FOR THIS UNIT AND IT SHOWED NO IRREGULARITIES DURING MANUFACTURING THAT WERE RELEVANT TO THIS ISSUE. 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. 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 THE SOLVENT DISPENSING PUMPS FOR THE ENTIRE MONTH IN WHICH THIS LOT WAS BUILT. 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 PART, 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 AND 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 A DONATION, THERE WAS A LEAK IN THE CENTRIFUGE AND THE PROCEDURE WAS ABORTED DUE TO THE LEAK. THE DONOR DID NOT EXPERIENCE ANY ADVERSE EVENTS IN RELATION TO THIS EVENT. THIS REPORT IS BEING FILED IN RESPONSE TO THE CUSTOMER FILING A SAE REPORT WITH THEIR LOCAL AUTHORITIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303273 SPECTRA OPTIA SPECTRA OPTIA COLLECT SET LKN TERUMO BCT 10U3113

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR