BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERAKOS CELLEX PHOTOPHERESIS SYSTEM

    MDR report key: 3964307 · Received June 19, 2014

    Report

    Report Number
    2523595-2014-00165
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    May 27, 2014
    Report Date
    May 27, 2014
    Manufacturer
    THERAKOS, INC.
    Product Code
    LNR
    PMA / PMN Number
    P680003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH RECORD REVIEW OF LOT B352 WAS CONDUCTED. THERE WERE NO NON CONFORMANCES RELATED TO THIS LOT. LOT MET RELEASE REQUIREMENTS. TRENDS HAVE BEEN REVIEWED FOR THIS COMPLAINT CATEGORY AND NO TREND HAS BEEN DETECTED; HOWEVER, CAPA'S (B)(4) ARE ALREADY OPENED TO INVESTIGATE PTO LEAKS. SERVICE ORDER (B)(4) COMPLETED: SERVICE FIELD ENGINEER PULLED PUMP DECK OUT AND CLEANED THE BLOOD. CHECKED THE CONDITION OF ALL AFFECTED PARTS. PERFORMED SYSTEM CHECKOUT. NO FURTHER ACTION REQUIRED. THE RETURNED KIT WAS RECEIVED FOR ANALYSIS AND TESTED. TESTING DETERMINED THAT THE SYSTEM PRESSURE DOME WAS NOT INSTALLED CORRECTLY. OPERATOR ERROR WAS THE CAUSE OF THE LEAK AND NOT A PROBLEM WITH THE KIT. BASED ON THE ANALYSIS FOR THIS COMPLAINT, NO REMEDIAL ACTION WAS TAKEN. COMPLAINTS OF THIS NATURE ARE MONITORED THROUGH TRACKING AND TRENDING. SHOULD A TREND ARISE, FURTHER ACTION WILL BE TAKEN. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT A BLOOD LEAK FROM THE SYSTEM PRESSURE DOME, CUSTOMER STATES THAT WHEN SHE INSTALLED THE KIT, SHE DID NOT NOTICE ANYTHING WRONG WITH THE PRESSURE DOME MEMBRANES, NO ALARMS OCCURED DURING PRIME, NO LEAKS WERE SEEN AFTER PRIME WAS COMPLETE. CUSTOMER STATED THAT ABOUT 15-20 MINUTES INTO THE PATIENT TREATMENT, SHE NOTICED BLOOD LEAKING FROM THE SYSTEM PRESSURE DOME ONTO THE PUMP DECK. SHE IMMEDIATELY ABORTED THE TREATMENT. MALE PATIENT IN DOUBLE NEEDLE CONFIGURATION, CUSTOMER ESTIMATES THE TOTAL BLOOD LOSS TO BE APPROXIMATELY 170ML. CUSTOMER STATES SHE PLANS TO TREAT THIS PATIENT AGAIN TODAY. UPDATE (B)(4) 2014: CSS CALLED THE CUSTOMER BACK TO FOLLOW UP, CUSTOMER STATED THAT THE PATIENT TREATMENT WAS PROGRESSING WITHOUT ANY ALARMS OR LEAKS USING THE SAME CELLEX INSTRUMENT AND THE PATIENT IS DOING GREAT, STABLE. SERVICE ORDER (B)(4) WAS DISPATCHED. CUSTOMER WILL RETURN THE KIT FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359406 THERAKOS CELLEX PHOTOPHERESIS SYSTEM CELLEX LNR THERAKOS, INC. B352/88-KIT

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR