BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERAKOS CELLEX SYSTEM

    MDR report key: 3837776 · Received March 5, 2014

    Report

    Report Number
    2523595-2014-00069
    Event Type
    Malfunction
    Date Received
    March 5, 2014
    Date of Event
    February 7, 2014
    Report Date
    February 7, 2014
    Manufacturer
    THERAKOS, INC.
    Product Code
    LNR
    PMA / PMN Number
    P680003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH RECORD REVIEW OF LOT B125 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 INFORMATION AVAILABLE AT THE TIME OF THE INVESTIGATION. PRODUCT WAS NOT RETURNED BY CUSTOMER FOR INVESTIGATION, BUT A PHOTO EVALUATION IS STILL IN PROGRESS; THEREFORE, NO ROOT CAUSE COULD BE DETERMINED AT THIS TIME AS EVALUATION IS STILL IN PROGRESS. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT A TUBING LEAK THAT OCCURRED DURING TREATMENT. NAME AND FUNCTION OF COMPLAINANT: SAME AS REPORTER. CUSTOMER CALLED TO REPORT THAT DURING THE TREATMENT THE TUBING SEGMENT INSTALLED IN THE RECIRCULATION PUMP HAS BEEN TORN OFF THE PUMP TUBING ORGANIZER. CUSTOMER STATED THAT THE INCIDENT OCCURRED AT 1036 ML WHOLE BLOOD PROCESSED. PRIME FLUID DID NOT EXIT THE KIT, BUT NO BLOOD SPILLED OVER THE PUMP DECK. NO ALARM DID OCCUR DURING THE LEAK. NO ALARM OR VISIBLE LEAK OCCURRED DURING PRIME AND DURING THE TREATMENT BEFORE THE INCIDENT OCCURRED. OPERATORS PERFORMED ALL THE USUAL CONTROLS DURING KIT INSTALLATION TREATMENT WAS ABORTED AND PATIENT IS STABLE. CUSTOMER THREW KIT AWAY, SO NO INVESTIGATION WILL BE PERFORMED ON THE KIT USED. CUSTOMER PROVIDED ONE PICTURE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131523 THERAKOS CELLEX SYSTEM CELLEX LNR THERAKOS, INC. B125 KIT

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR