BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERAKOS CELLEX PHOTOPHERESIS SYSTEM

    MDR report key: 3834613 · Received March 19, 2014

    Report

    Report Number
    2523595-2014-00083
    Event Type
    Malfunction
    Date Received
    March 19, 2014
    Date of Event
    February 21, 2014
    Report Date
    February 21, 2014
    Manufacturer
    THERAKOS INC
    Product Code
    LNR
    PMA / PMN Number
    P980003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF LOT FILE B335 WAS PERFORMED. THERE WERE NO NONCONFORMANCES ASSOCIATED WITH THIS EVENT TYPE REPORTED FOR THIS LOT NUMBER. THIS LOT MET ALL RELEASE REQUIREMENTS. TRENDS HAVE BEEN RECEIVED FOR THIS COMPLAINT CATEGORY AND NO TREND HAS BEEN DETECTED. SRV#(B)(4) SERVICE ORDER FEEDBACK: FIELD ENGINEER PERFORMED SYSTEM CHECKOUT PROCEDURE, RECALIBRATED PRESSURE TRANSDUCER AND DOUBLE CHECKED TRANSDUCER PER CALIBRATION. THE ASSESSMENT IS BASED ON INFORMATION AVAILABLE AT THE TIME OF THE INVESTIGATION. NO PRODUCT WAS RETURNED BY THE CUSTOMER. THEREFORE, THE ROOT CAUSE FOR THE LEAK CANNOT BE DETERMINED BASED SOLELY ON THE INFORMATION PROVIDED BY THE CUSTOMER. CAPA (B)(4) HAVE BEEN INITIATED TO INVESTIGATE CELLEX PRESSURE DOME LEAKS. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER IS REPORTING A PRESSURE DOME LEAK. NAME AND FUNCTION OF COMPLAINANT: SAME AS REPORTER CUSTOMER CALLED TO REPORT SYSTEM PRESSURE ALARMS X3 FOLLOWED BY A BLOOD LEAK AT THE SYSTEM PRESSURE DOME AFTER 231ML WHOLE BLOOD PROCESSED. TREATMENT WAS ABORTED. CUSTOMER CHOSE TO RETURN THE BLOOD FROM THE RETURN BAG TO THE PT MANUALLY AND START ANOTHER TREATMENT. NO FURTHER TESTS OR INTERVENTIONS WILL BE DONE. PT IS STABLE. SERVICE ORDER SRV# (B)(4) WAS DISPATCHED FOR INSPECTION OF THE INSTRUMENT. CUSTOMER DID NOT RETURN ANY PRODUCT FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162645 THERAKOS CELLEX PHOTOPHERESIS SYSTEM CELLEX SCP SYSTEM LNR THERAKOS INC 6661 B335-KIT

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR