BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERAKOS CELLEX PHOTOPHERESIS SYSTEM

    MDR report key: 4121534 · Received July 29, 2014

    Report

    Report Number
    2523595-2014-00195
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 2, 2014
    Manufacturer
    THERAKOS, INC.
    Product Code
    LNR
    PMA / PMN Number
    P680003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF LOT C322 WAS CONDUCTED. THERE WERE NO NONCONFORMANCES ASSOCIATED WITH THIS LOT. THE LOT MET RELEASE REQUIREMENTS. TRENDS HAVE BEEN REVIEWED FOR THIS COMPLAINT CATEGORY AND NO TRENDS HAVE BEEN DETECTED FOR DRIVE TUBE LEAK/BREAKS; CAPA (B)(4) IS ALREADY OPENED TO INVESTIGATE DRIVE TUBE LEAK/BREAKS. SERVICE ORDER (B)(4) COMPLETED: SERVICE ENGINEER CLEANED BLOOD FROM CENTRIFUGE AREA THOROUGHLY WITH BLEACH SOLUTION, REPLACED BROKEN LEAK STRIP, REPLACED BLOWN F5 FUSES WHICH CAUSED SYSTEM ERROR#3 DUE TO NO COMPRESSOR POWER; PERFORMED SYSTEM CHECKOUT PROCEDURE; NO FURTHER ACTION REQUIRED. THE ASSESSMENT IS BASED ON INFO AVAILABLE AT THE TIME OF THE INVESTIGATION. NO PRODUCT WAS RETURNED FOR INVESTIGATION; THEREFORE, IT COULD NOT BE DETERMINED IF THE PRODUCT MET SPEC BASED SOLELY ON THE INFO PROVIDED BY THE CUSTOMER. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT DRIVE TUBE LEAK DURING TREATMENT PROCEDURE. SINGLE NEEDLE MODE, VORTEX PORT, 500 ML WHOLE BLOOD PROCESSED. CSS ASKED IF PT WAS OKAY, CUSTOMER STATED YES, PT IS STABLE. CSS ASKED IF ANYONE WAS EXPOSED TO BLOOD/FLUIDS, CUSTOMER STATED NO ONE WAS EXPOSED DUE TO LEAK BEING CONTAINED WITHIN THE CENTRIFUGE. CSS ASKED IF THERE WERE ANY ALARMS DURING PRIME. CUSTOMER STATED SHE DID GET AN AIR DETECTED ALARM, BUT DID NOT SEE ANY AIR IN THE KIT. CUSTOMER STATED SHE CHECKED THE ACCESS AND NOTED IT WAS A POSITIONAL ISSUE WITH ACCESS. SO SHE PASSED THE PROCEDURE TO FLUSH THE LINE. SHE RESTARTED THE PROCEDURE. IT WAS SHORTLY AFTER RESTARTING, THE DRIVE TUBE LEAK OCCURRED. CSS ASKED CUSTOMER IF THERE WERE ANY ALARMS DURING PRIME, CUSTOMER STATED NO THERE WERE NONE. SERVICE ORDER (B)(4) WAS DISPATCHED. CUSTOMER DID NOT RETURN PRODUCT FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442711 THERAKOS CELLEX PHOTOPHERESIS SYSTEM CELLEX LNR THERAKOS, INC. C322 - KIT

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR