BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERAKOS UVAR XTS PHOTOPHERESIS SYS

    MDR report key: 3647412 · Received January 6, 2014

    Report

    Report Number
    2523595-2014-00023
    Event Type
    Malfunction
    Date Received
    January 6, 2014
    Date of Event
    February 18, 2013
    Report Date
    February 18, 2013
    Manufacturer
    THERAKOS, INC.
    Product Code
    LNR
    PMA / PMN Number
    P680003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE LOT FILE FOR A739 WAS PERFORMED. THERE WERE NO NON CONFORMANCES ASSOCIATED WITH THIS LOT. TWO ALARMS WERE NOTED DURING INTEGRITY TESTING: BLOOD LEA DURING PRIME: NO LEAK FOUND, TESTING RESTARTED. BLOOD LEAK AT START OF PHOTOACTIVATION: NO LEAK FOUND, TESTING RESTARTED. THIS LOT MET ALL RELEASE REQUIREMENTS. A REVIEW OF COMPLAINTS RECEIVED FOR LOT A739 WAS PERFORMED. THERE WERE 4 COMPLAINTS REPORTED FOR BOWL LEAKS TO DATE FOR THIS LOT. A TREND HAS BEEN DETECTED WHERE 3 COMPLAINTS HAVE BEEN REPORTED REGARDING THE BOTTOM BEING DETACHED FROM THE TOP OF THE BOWL DURING THE TREATMENT. DRA (B)(4) HAS BEEN OPENED FOR AN INVESTIGATION. SERVICE ORDER # (B)(4) FEEDBACK: CENTRIFUGE & VACUUM PUMP EXCHANGE. SETTINGS CHECKED AND PARTIALLY ADJUSTED. REPAIRS HAVE RETURNED THIS INSTRUMENT TO EXPECTED OPERATION. THIS ASSESSMENT IS BASED ON THE INFORMATION AVAILABLE AT THE TIME OF THE INVESTIGATION. THE DATA KEY ONLY, NO KIT, WAS RECEIVED AND ANALYZED. BASED ON THE INVESTIGATION FOR THIS COMPLAINT NO REMEDIAL ACTION WAS TAKEN. A MORE THOROUGH INVESTIGATION WOULD HAVE BEEN POSSIBLE IF THE BOWL WAS RETURNED FOR EXAMINATION. COMPLAINTS OF THIS NATURE ARE MONITORED THROUGH TRACKING AND TRENDING. SHOULD A TREND ARISE, FURTHER ACTION WILL BE TAKEN. MXP# (B)(4). REFER TO CAPA# (B)(4). KIT LOT A739 WAS THE ONLY LOT WITH MORE THEN ONE BOWL BREAK AND RETURN TO INVESTIGATE. THIS LOT, A739, WAS TRACED BACK TO BOWL LOTS BB 120634 AND BB 120903. BATCH RECORDS FOR THESE LOTS WER REVIEWED WITH NO PROBLEMS FOUND. FIRE AND ICE TEST DATA WAS REVIEWED AND MET ALL SPECIFICATIONS. BASED UPON THE REVIEW OF ALL AVAILABLE DATE, NO TRENDS WERE FOUND. ALL DATA SUPPORTING THESE REVIEWS IS ATTACHED TO THIS RECORD. NO FURTHER INVESTIGATION WILL BE CONDUCTED. NO ACTIONS WILL TAKE PLACE. SHOULD FUTURE COMPLAINT DATA INDICATE ADDITIONAL BOWL BREAKS EXCEEDING MONTHLY THRESHOLD LIMITS, FURTHER REVIEW WILL TAKE PLACE. THIS RECORD IS BEING CLOSED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AS CENTRIFUGE BOWL LEAK. COMPLAINT: SAME AS REPORTER. CUSTOMER REPORTED A BOWL LEAK DURING COLLECT 1ST CYCLE. LOUD BANG AUDIBLE. CUSTOMER STATES THAT BOTTOM OF BOWL IS DETACHED FROM REMAINDER OF BOWL. DRAIN BAG FILLED WITH BLOOD. CUSTOMER CLEANED AS MUCH AS POSSIBLE & STATES THAT GLASS OF CENTRIFUGE COVER IS DAMAGED. NO ALARMS DURING PRIME/TREATMENT PRIOR TO ISSUE. SERVICE ORDER # (B)(6) WAS DISPATCHED FOR INSPECTION OF THE INSTRUMENT. CUSTOMER RETURNED DATA KEY FOR INVESTIGATION

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8013 THERAKOS UVAR XTS PHOTOPHERESIS SYS UVAR XTS EXP SYS LNR THERAKOS, INC. 6660 A739-KIT

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR