BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERAKOS CELLEX PHOTOPHERESIS SYSTEM

    MDR report key: 3787250 · Received February 4, 2014

    Report

    Report Number
    2523595-2014-00054
    Event Type
    Malfunction
    Date Received
    February 4, 2014
    Date of Event
    January 7, 2014
    Report Date
    January 7, 2014
    Manufacturer
    THERAKOS, INC.
    Product Code
    LNR
    PMA / PMN Number
    P680003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF LOT FILE (B)(4) WAS PERFORMED. THERE WERE NO NON-CONFORMANCES ASSOCIATED WITH THIS LOT. THIS LOT MET ALL RELEASE REQUIREMENTS. A COMPLAINT LOT REVIEW OF (B)(4) WAS CONDUCTED AND THERE WERE NO OTHER PHOTOACTIVATION MODULE LEAKS REPORTED TO DATE FOR THIS LOT. NO TRENDS WERE DETECTED. SERVICE ORDER FEEDBACK (B)(4): THE FIELD ENGINEER CHECKED PLATE LEAK DETECTOR. OK. FE INSTALLED A NEW SET OF LAMPS AS THE OLD ONES WERE CONTAMINATED. FE COMPLETED A FULL CHECKOUT PROCEDURE. THIS HAS RETURNED THE INSTRUMENT TO ITS INTENDED PERFORMANCE. THE ASSESSMENT IS BASED ON INFO AVAILABLE AT THE TIME OF THE INVESTIGATION. NO PRODUCT WAS RETURNED FOR INVESTIGATION. THEREFORE, THE ROOT CAUSE OF THE LEAK CANNOT BE DETERMINED BASED SOLELY ON THE INFO PROVIDED BY THE CUSTOMER. CAPA # (B)(4) HAS BEEN OPENED FOR CELLEX TUBING BOND LEAKS. MXP# (B)(4).

    Description of Event or Problem · 1

    CUSTOMER IS REPORTING A PHOTOACTIVATION MODULE LEAK. NAME AND FUNCTION OF COMPLAINANT: SAME AS REPORTER. SYSTEM HAS BEEN SETUP FOR A BLOOD PRIME. TREATMENT WORKED FINE. BUFFY COAT (BC) HAD BEEN COLLECTED. SYSTEM SHOWED A VERY SHORT PHOTOACTIVATION TIME OF 2 MINS WHILE CUSTOMER EXPECTED AROUND 15 MINS. CUSTOMER PRESSED THE PHOTOACTIVATION BUTTON, THE BC EMPTIED AND WAS LEAKING OUT OF THE PHOTOACTIVATION CHAMBER INTO THE LIGHT BOX. THE BOX WAS FULL OF BUFFY COAT. CUSTOMER STATED THAT THE LEAK APPEARED TO BE AT THE SEAL OF THE PHOTOACTIVATION CHAMBER. CUSTOMER STATED THAT THE PT WAS FINE AND NO FLUID HAS BEEN LOST AS HE WAS SETUP IN A BLOOD PRIME TREATMENT. SERVICE ORDER# (B)(6) WAS DISPATCHED FOR INSPECTION OF THE INSTRUMENT. NO PRODUCT WILL BE RETURNED BY THE CUSTOMER FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72824 THERAKOS CELLEX PHOTOPHERESIS SYSTEM CELLEX ECP SYSTEM LNR THERAKOS, INC. 6661 B131/237 KIT

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR