BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERAKOS CELLEX PHOTOPHERESIS SYSTEM

    MDR report key: 4811594 · Received June 2, 2015

    Report

    Report Number
    2523595-2015-00154
    Event Type
    Malfunction
    Date Received
    June 2, 2015
    Date of Event
    May 6, 2015
    Report Date
    May 6, 2015
    Manufacturer
    THERAKOS, INC
    Product Code
    LNR
    PMA / PMN Number
    P860003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THE TIME OF THE INITIAL REPORT, NO PRODUCT HAD BEEN RETURNED. THE HCT CUVETTE AND SMARTCARD WERE RETURNED FOR ANALYSIS. THE SMARTCARD REVIEW INDICATED THAT PRIME WAS COMPLETED SUCCESSFULLY. BLOOD COLLECTION WAS STARTED, 1118ML OF WHOLE BLOOD WAS PROCESSED, AND THE TREATMENT WAS ABORTED DUE TO THE CENTRIFUGE PAUSE WARNING. THE RETURNED HCT CUVETTE WAS PRESSURE TESTED AND BUBBLES FROM ONE OF THE JOINTS BETWEEN TUBING AND THE CUVETTE CONFIRMED THE LEAK. AFTER INSPECTING THE RETURNED CUVETTE, IT ALSO CONFIRMED THE DETACHED TUBING. THE TUBE DETACHED FROM THE CUVETTE INDICATES A LIKELY ROOT CAUSE OF MANUFACTURING ERROR. A NON-UNIFORM SEAL WILL FORM A WEAK BOND, AND IS LIKELY THE ROOT CAUSE OF THE TUBING ISSUE UPON CUSTOMER USE. CORRECTIVE ACTIONS WERE INITIATED AND MANUFACTURING OPERATORS WERE TRAINED. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT. A BATCH RECORD REVIEW WAS PERFORMED FOR LOT D302. THERE WERE NO NON-CONFORMANCES. THIS LOT MET ALL RELEASE REQUIREMENTS. THE UVADEX LOT NUMBER WAS NOT PROVIDED AS IT WAS NOT ADMINISTERED. HOWEVER, A REVIEW OF ALL UVADEX LOTS MANUFACTURED SINCE JANUARY 2013 WAS PERFORMED. NO TRENDS OR NONCONFORMANCES RELATED TO THE COMPLAINT WERE NOTED. TRENDS WERE REVIEWED FOR ALL COMPLAINT CATEGORIES AND NO TREND WAS DETECTED FOR TUBING LEAK. NO CORRECTIVE AND PREVENTIVE ACTION HAS BEEN INITIATED FOR THIS TYPE OF TUBING LEAK. THIS ASSESSMENT IS BASED ON THE INFORMATION AVAILABLE AT THE TIME OF THE INVESTIGATION. NO PRODUCT WAS RETURNED BY THE CUSTOMER FOR INVESTIGATION; THEREFORE, IT COULD NOT BE DETERMINED IF PRODUCT MET SPECIFICATION. COMPLAINTS ARE MONITORED THROUGH TRACKING AND TRENDING. IF A TREND IS DETECTED, FURTHER INVESTIGATION WILL BE CONDUCTED THROUGH THE CAPA/CONTINUOUS IMPROVEMENT PROCESS. (B)(4). DEVICE NOT RETURNED

    Description of Event or Problem · 1

    CUSTOMER REPORTED SALINE WAS OBSERVED LEAKING FROM A TUBING CONNECTION AT THE HEMATOCRIT SENSOR WHEN A SINGLE NEEDLE MODE TREATMENT HAD REACHED 1118 ML WHOLE BLOOD PROCESSED. CUSTOMER REPORTED THE TUBING FELL OFF THE HEMATOCRIT CUVETTE WHEN HE REMOVED THE CUVETTE FROM THE HEMATOCRIT SENSOR. CUSTOMER REPORTED NO ALARMS HAD OCCURRED. CUSTOMER ASKED ABOUT ENDING THE TREATMENT TO RETURN THE BLOOD IN THE KIT TO THE PATIENT. CSS ADVISED CUSTOMER THERAKOS DOES NOT RECOMMEND RETURNING THE BLOOD TO THE PATIENT IF THE STERILITY OF THE KIT HAS BEEN COMPROMISED. CUSTOMER CONSULTED WITH THE ATTENDING PHYSICIAN, AND ELECTED TO ABORT THE TREATMENT WITHOUT RETURNING THE BLOOD IN THE KIT TO THE PATIENT. CUSTOMER ESTIMATED A BLOOD LOSS OF ABOUT 242 ML, INCLUDING THE 140 ML IN THE BOWL AND THE DISPLAYED FLUID BALANCE OF -102 ML WHEN THE TREATMENT WAS ABORTED. CUSTOMER CALLED BACK A SHORT TIME LATER AND REPORTED THEY HAD STARTED A NEW TREATMENT FOR THE PATIENT. CUSTOMER DID NOT RETURN PRODUCT FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355745 THERAKOS CELLEX PHOTOPHERESIS SYSTEM CELLEX LNR THERAKOS, INC D302 - KIT

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR