BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERAKOS CELLEX PHOTOPHERESIS SYSTEM

    MDR report key: 3853528 · Received April 3, 2014

    Report

    Report Number
    2523595-2014-00106
    Event Type
    Malfunction
    Date Received
    April 3, 2014
    Date of Event
    March 13, 2014
    Report Date
    March 13, 2014
    Product Code
    LNR
    PMA / PMN Number
    P680003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A BATCH RECORD REVIEW OF LOT B303 WAS PERFORMED AND THERE WERE NO NONCONCORDANCES ASSOCIATE WITH THIS EVENT TYPE REPORTED FOR THIS LOT. THIS LOT MET RELEASE REQUIREMENTS. TRENDS HAE BEEN REVIEWED ON A LOT BY LOT BASIS FOR THIS COMPLAINT CATEGORY AND NO TREND HAS BEEN DETECTED FOR THIS LOT; HOWEVER, CAPA (B)(4) HAS ALREADY BEEN INITIATED TO INVESTIGATE DRIVE TUBE LEAKS/BREAKS. (B)(4) SERVICE ORDER FEEDBACK: FIELD ENGINEER REPLACED CENTRIFUGE LEAK DETECTOR, CLEANED INSTRUMENT AND PERFORMED SYSTEM CHECKOUT. ALL PASSED. THE ASSESSMENT IS BASED ON INFORMATION AVAILABLE AT THE TIME OF THE INVESTIGATION. NO PRODUCT WAS RETURNED BY THE CUSTOMER. THEREFORE, NO ROOT CAUSE COULD BE DETERMINED BASED SOLELY ON THE INFORMATION PROVIDED BY THE CUSTOMER. COMPLAINTS OF THIS NATURE ARE MONITORED THROUGH TRACKING AND TRENDING. SHOULD A TREND ARISE, FURTHER ACTION WILL BE TAKEN.

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT THAT HE HAD A DRIVE TUBE BREAK EARLY IN THE PROCEDURE. PATIENT HAD MINIMAL BLOOD LOSS AND WAS DONE IMMEDIATELY AFTER ON ANOTHER INSTRUMENT WITH NO REACTION. INSTRUMENT WITH THE DRIVE TUBE BREAK WAS CLEANED, BUT IS IN NEED OF SERVICE DUE TO THE LEAK STRIP BEING DAMAGED. CUSTOMER STATED THAT THE PATIENT WAS STABLE. CSS WILL DISPATCH SERVICE TO INSPECT INSTRUMENT. (B)(4) WAS DISPATCHED TO INSPECT THE INSTRUMENT. NO PRODUCT WAS RETURNED BY THE CUSTOMER FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203001 THERAKOS CELLEX PHOTOPHERESIS SYSTEM CELLEX LNR B303- KIT

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK