BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERAKOS CELLEX PHOTOPHERESIS SYSTEM

    MDR report key: 3964294 · Received June 19, 2014

    Report

    Report Number
    2523595-2014-00175
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 20, 2014
    Manufacturer
    THERAKOS, INC.
    Product Code
    LNR
    PMA / PMN Number
    P680003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    TRENDS HAVE BEEN REVIEWED ON A LOT BY LOT BASIS FOR THIS COMPLAINT CATEGORY AND NO TREND HAS BEEN DETECTED FOR THIS SPECIFIC LOT. A REVIEW OF C110 WAS PERFORMED AND THERE WERE NO NON-CONFORMANCES ASSOCIATED WITH THIS LOT. THE LOT MET RELEASE REQUIREMENTS. AT THE TIME OF THIS INVESTIGATION, NO TRENDS WERE OBSERVED FOR THIS EVENT TYPE. HOWEVER, CAPA (B)(4) WAS INITIATED TO INVESTIGATED TUBING LEAK. THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION, THEREFORE, IT COULD NOT BE DETERMINED IF THE PRODUCT MET SPECIFICATIONS. COMPLAINTS OF THIS NATURE ARE KNOWN TO OCCUR IN RARE OCCASION AND ARE BEING MONITORED THROUGH TRACKING AND TRENDING. IF A TREND IS DETECTED, FURTHER INVESTIGATION WILL BE CONDUCTED THROUGH THE CAPA/CONTINUOUS IMPROVEMENT PROCESS. NO FURTHER ACTION IS REQUIRED AT THIS TIME. SERVICE ORDER NUMBER (B)(4) WAS DISPATCHED AND COMPLETED. INSTRUMENT WAS CLEANED AND CHECKED OUT OK. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED A BLOOD LEAK AT THE TUBING AROUND THE COLLECT PUMP #1 WHEN THE RED BLOOD CELL PUMP (PRBC) PATIENT WAS NOT CONNECTED. AFTER HAVING INSTALLED THE KIT, PRIME STARTED AND ALARM # 28 PRIME 4 OCCURRED AND NURSE HAS VERIFIED THAT THE COLLECT LINE FROM THE SYSTEM PRESSURE DOME TO THE BOWL WAS PINCHED. THE NURSE FIXED THE ISSUE AND RESUMED THE PRIME THAT COMPLETED FINE. THEN THE NURSE CONNECTED THE COLLECT LINE TO THE PRBC AND, AT 100 ML OF WHOLE BLOOD PROCESSED, SAW BLOOD LEAK ON THE TUBING AROUND THE COLLECT PUMP. THE NURSE ABORTED THE TREATMENT, REMOVED THE KIT AND CLEANED THE PUMP DESK. HOWEVER, THERE WAS SOME BLOOD UNDER THE COLLECT PUMP HANDLE. SERVICE WAS DISPATCHED PER CUSTOMER'S REQUEST. PRODUCT WAS NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360903 THERAKOS CELLEX PHOTOPHERESIS SYSTEM CELLEX LNR THERAKOS, INC. C110 - KIT

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK