BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERAKOS CELLEX PHOTOPHERSIS SYSTEM

    MDR report key: 4172845 · Received October 10, 2014

    Report

    Report Number
    2523595-2014-00273
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    September 23, 2014
    Report Date
    September 23, 2014
    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 BATCH RECORD REVIEW OF LOT C128 WAS CONDUCTED. THERE WERE NO NONCONFORMANCES ASSOCIATED WITH THIS LOT. THE LOT MET RELEASE REQUIREMENTS. TRENDS WERE REVIEWED FOR COMPLAINT CATEGORIES, ALARM #52: COLLECT LINE AIR DETECTED AND ALARM #53: RETURN LINE AIR DETECTED. NO TRENDS WERE DETECTED FOR COMPLAINT CATEGORIES, ALARM #52: COLLECT LINE AIR DETECTED AND ALARM #53: RETURN LINE AIR DETECTED. NO CAPAS WERE INITIATED FOR EITHER OF THESE COMPLAINT CATEGORIES. THIS COMPLAINT IS BEING REPORTED DUE TO THE MEDICAL INTERVENTION (UNPLANNED TRANSFUSION) AND NOT DUE TO THE INSTRUMENT ALARMS. THIS ASSESSMENT IS BASED ON INFO AVAILABLE AT THE TIME OF INVESTIGATION. THE KIT WAS NOT RETURNED FOR EVALUATION; HOWEVER, THE SMARTCARD WAS RETURNED FOR EVALUATION. ANALYSIS OF THE RETURNED SMARTCARD DATA IS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE FILED WHEN THIS ANALYSIS IS COMPLETE. (B)(4); (B)(4) 2014.

    Description of Event or Problem · 1

    THE CUSTOMER CALLED AFTER THEY HAD ALREADY ABORTED THE TREATMENT, TO REPORT MULTIPLE ALARM #52: COLLECT LINE AIR DETECTED AND ALARM #53: RETURN LINE AIR DETECTED ALARMS AFTER ABOUT 700ML OF WHOLE BLOOD PROCESSED. THE CUSTOMER COULD NOT FIND FROM WHERE THE AIR WAS COMING. THE CUSTOMER THEN STATED THAT THE POWER CORD WAS PULLED OUT BY FAULT AFTER ABOUT 700ML OF WHOLE BLOOD PROCESSED. THE ALARMS RECURRED AFTER THE RESTART OF THE INSTRUMENT. THE CUSTOMER DECIDED TO ADMINISTER ONE RBC TRANSFUSION, IN ORDER TO COMPENSATE FOR THE VOLUME LOST IN THE ABORTED TREATMENT. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. NO SERVICE ORDER WAS GENERATED. THE KIT WAS NOT RETURNED FOR EVALUATION; HOWEVER, THE CUSTOMER SENT THE SMARTCARD FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642665 THERAKOS CELLEX PHOTOPHERSIS SYSTEM CELLEX LNR THERAKOS, INC. C128-KIT

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Required Intervention