BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERAKOS CELLEX SYSTEM

    MDR report key: 3910040 · Received February 25, 2014

    Report

    Report Number
    2523595-2014-00050
    Event Type
    Malfunction
    Date Received
    February 25, 2014
    Date of Event
    January 30, 2014
    Report Date
    January 30, 2014
    Manufacturer
    THERAKOS, INC.
    Product Code
    LNR
    PMA / PMN Number
    P680003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH RECORD REVIEW OF LOT B335 WAS CONDUCTED. THERE WERE NO NON CONFORMANCES RELATED TO THIS TYPE OF FAILURE FOR THIS LOT. LOT MET RELEASE REQUIREMENTS. TRENDS HAVE BEEN REVIEWED ON A LOT BY LOT BASIS FOR THIS COMPLAINT CATEGORY AND NO TREND HAS BEEN DETECTED FOR THIS SPECIFIC LOT. THE ASSESSMENT IS BASED ON INFO AVAILABLE AT THE TIME OF THE INVESTIGATION. PRODUCT WAS RETURNED BY CUSTOMER FOR INVESTIGATION; NO ROOT CAUSE COULD BE DETERMINED AT THIS TIME AS INVESTIGATION IS STILL IN PROGRESS. (B)(4) STILL PENDING.

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT A BLOOD LEAK THAT OCCURRED DURING TREATMENT. NAME AND FUNCTION OF COMPLAINANT: SAME AS REPORTER. CUSTOMER CALLED TO REPORT A DRIVE TUBE BREAK RIGHT ABOVE THE DRIVE TUBE LATCH. ALARMS EARLY IN THE PROCEDURE INCLUDE PRIME #23, RETURN PRESSURE TEST FAILURE, AND A SYSTEM PRESSURE ALARM DURING TREATMENT. AFTER THE CENTRIFUGE RESUMED FROM THE SYSTEM PRESSURE ALARM, THE DRIVE TUBE BROKE RESULTING IN ALARM #7, BLOOD LEAK. CUSTOMER STATED THEY DID NOT TAKE OUT THE BOWL OR OTHER TUBING WHEN THE CENTRIFUGE STOPPED FOR THE SYSTEM PRESSURE ALARM. CUSTOMER STATES THE CENTRIFUGE IS DENTED FROM THE DRIVE TUBE, AND THE LEAK DETECTOR STRIP IS DAMAGED. THE CENTRIFUGE BOWL REMAINED ON THE PLATFORM. CUSTOMER AGREED TO SEND THE TUBING BACK FOR INVESTIGATION. CSS TO DISPATCH SERVICE AND REQUEST A KIT CREDIT. NO KIT WAS RETURNED FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116164 THERAKOS CELLEX SYSTEM CELLEX LNR THERAKOS, INC. 6660 B335 KIT

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR