BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERAKOS CELLEX PHOTOPHERESIS SYSTEM

    MDR report key: 4172876 · Received October 10, 2014

    Report

    Report Number
    2523595-2014-00266
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    September 18, 2014
    Report Date
    September 18, 2014
    Manufacturer
    THERAKOS, INC.
    Product Code
    LNR
    PMA / PMN Number
    P680003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH RECORD REVIEW OF LOT C335 WAS CONDUCTED. THERE WERE NO NONCONFORMANCE ASSOCIATED WITH THIS LOT. THE LOT MET RELEASE REQUIREMENTS. TRENDS WERE REVIEWED FOR COMPLAINT CATEGORY, PRESSURE DOME MEMBRANE LEAK AND NO TREND WAS DETECTED FOR THIS COMPLAINT CATEGORY. CAPA (B)(4) HAVE ALREADY BEEN INITIATED TO INVESTIGATE PRESSURE DOME MEMBRANE LEAKS. A REVIEW OF LOT C335 SHOWS NO TRENDS. (B)(4) COMPLETED: SERVICE TECH REPLACED ALL FIVE PUMP HEADS TO ENSURE THAT BLOOD INTRUSION INTO PUMP ROLLERS DOES NOT SEIZE THE ROLLERS. CLEANED AFFECTED AREAS AND PERFORMED SYSTEM CHECKOUT. THIS 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 THIS SPECIFIC PRODUCT MET SPECS BASED SOLELY ON INFO PROVIDED BY THE CUSTOMER. COMPLAINTS ARE MONITORED THROUGH TRACKING AND TRENDING. IF A TREND IS OBSERVED, FURTHER ACTION WILL BE TAKEN. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED A BLOOD LEAK WAS OBSERVED AT THE SYSTEM PRESSURE DOME AREA DURING THE BUFFY COLLECT PHASE OF A SINGLE NEEDLE MODE TREATMENT. THE TREATMENT WAS ABORTED AT THAT TIME, AND THE BLOOD IN THE KIT WAS NOT RETURNED TO THE PT. CUSTOMER ESTIMATED APPROX 20 TO 30 ML OF BLOOD HAD LEAKED ONTO THE PUMP DECK. THE SPECIFIC LOCATION OF THE LEAK WAS NOT READILY VISIBLE. THE PT WAS REPORTED TO BE IN STABLE CONDITION. CUSTOMER REPORTED THAT THE KIT HAD BEEN DISCARDED. SERVICE ORDER (B)(4) WAS DISPATCHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642754 THERAKOS CELLEX PHOTOPHERESIS SYSTEM CELLEX LNR THERAKOS, INC. C335-KIT

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR