BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERAKOS CELLEX PHOTOPHERESIS SYSTEM

    MDR report key: 3853538 · Received April 3, 2014

    Report

    Report Number
    2523595-2014-00092
    Event Type
    Malfunction
    Date Received
    April 3, 2014
    Date of Event
    March 10, 2014
    Report Date
    March 11, 2014
    Manufacturer
    THERAKOS, INC.
    Product Code
    LNR
    PMA / PMN Number
    P680003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH RECORD REVIEW OF LOT B133 WAS CONDUCTED. THERE WERE NO NON CONFORMANCES RELATED TO THIS TYPE OF EVENT FOR THIS LOT. LOT MET RELEASE REQUIREMENTS. TRENDS HAVE BEEN REVIEWED FOR THIS COMPLAINT CATEGORY AND NO TREND HAS BEEN DETECTED FOR ANY LOT; HOWEVER, (B)(4) HAS ALREADY BEEN INITIATED TO INVESTIGATE FAILURES RELATED TO CELLEX DRIVE TUBE LEAKS/BREAKS. PHOTO EVALUATION WAS CONDUCTED AND IT WAS OBSERVED THAT A BLOOD LEAK OCCURRED; UNFORTUNATELY, EXAMINATION OF THE PHOTOGRAPH DID NOT PROVIDE A DEFINITIVE ROOT CAUSE FOR THE COMPLAINT. A MORE THOROUGH ANALYSIS COULD HAVE BEEN CONDUCTED IF THE KIT HAD BEEN RETURNED. 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 NOTIFIED THEIR ACCOUNT MANAGER OF A DRIVE TUBE BLOOD LEAK ON (B)(6) 2014, AND THE INFORMATION WAS EMAILED TO CSS (B)(6) 2014 AT 6:59 PM. CUSTOMER REPORTED THE KIT PRIMED CORRECTLY, THEN AT THE BEGINNING OF THE TREATMENT A BLOOD LEAK OCCURRED FROM A CUT ON THE DRIVE TUBE. CUSTOMER REPORTED HE WAS FINE AND THAT HIS HEMATOCRIT, HEMOGLOBIN AND BLOOD PRESSURE BEFORE AND AFTER THE TREATMENT WERE NORMAL, AND HE RECEIVED ANOTHER TREATMENT THE SAME DAY. NO PRODUCT WAS RETURNED FOR INVESTIGATION; HOWEVER, CUSTOMER PROVIDED PHOTOS FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201756 THERAKOS CELLEX PHOTOPHERESIS SYSTEM CELLEX LNR THERAKOS, INC. B133 -KIT

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR