BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERAKOS XTS SYSTEM

    MDR report key: 3870115 · Received April 29, 2014

    Report

    Report Number
    2523595-2014-00104
    Event Type
    Malfunction
    Date Received
    April 29, 2014
    Date of Event
    April 7, 2014
    Report Date
    April 7, 2014
    Manufacturer
    THERAKOS, INC.
    Product Code
    LNR
    PMA / PMN Number
    P680003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH RECORD REVIEW OF LOT C707 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; HOWEVER THERE IS CURRENTLY A MANUFACTURER'S CAPA ((B)(4)) OPENED TO INVESTIGATE XTS CENTRIFUGE BOWL LEAK/BREAK RELATED FAILURES. SERVICE ORDER (B)(4) COMPLETED: SERVICE FIELD ENGINEER CLEANED CENTRIFUGE AND REPLACED FLUID SENSOR. 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 SPECIFICATION BASED SOLELY ON THE INFO PROVIDED BY THE CUSTOMER. COMPLAINTS ARE MONITORED THROUGH TRACKING AND TRENDING; IF ADD'L INFO IS REC'D THE COMPLAINT WILL BE REOPEN AND PROCESSED ACCORDINGLY. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REQUEST A SERVICE VISIT BECAUSE LEAK ALARMS CANNOT BE RESOLVED. CUSTOMER STATED THERE WAS A BROWN-GRAY MASS IN THE CENTRIFUGE. CSS CALLED CUSTOMER NURSING DEPARTMENT AND ASKED TO SPEAK WITH ONE OF THE NURSES TO BETTER DESCRIBE THE REPORTED ALARM AND MASS IN THE CENTRIFUGE; CUSTOMER STATED THEY WERE TOO BUSY TO SPEAK AT THIS TIME. CSS CALLED CUSTOMER BACK SEVERAL TIMES AND FINALLY WAS ABLE TO SPEAK WITH ONE OF THE NURSES. CUSTOMER REPORTED THAT THE BOWL WAS REMOVED FROM THE CENTRIFUGE, NO BOWL DAMAGE WAS VISIBLE AND NO BLOOD LEAK WAS OBSERVED, BUT THE BOWL WAS THEN PLACED INTO A BAG AND CONDENSATION FROM THE BOWL WAS OBSERVED INSIDE THE BAG. CUSTOMER STATED THEY ESTIMATED THAT 345 ML OF BLOOD WAS NOT RETURNED TO THE PATIENT WHEN THE TREATMENT WAS ABORTED DUE TO THE LEAK ALARM EARLY IN CYCLE 2. SERVICE ORDER (B)(4) WAS DISPATCHED PER CUSTOMER'S REQUEST. NO PRODUCT WAS RETURNED FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256403 THERAKOS XTS SYSTEM XTS LNR THERAKOS, INC. C707-KIT

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR