BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERAKOS CELLEX PHOTOPHERESISI SYSTEM

    MDR report key: 4801947 · Received May 28, 2015

    Report

    Report Number
    2523595-2015-00158
    Event Type
    Malfunction
    Date Received
    May 28, 2015
    Date of Event
    May 8, 2015
    Report Date
    May 8, 2015
    Manufacturer
    THERAKOS INC.
    Product Code
    LNR
    PMA / PMN Number
    P860003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM WAS USED FOR TREATMENT. A BATCH RECORD REVIEW OF KIT LOT D311 WAS PERFORMED. THERE WERE NO NONCONFORMANCES RELATED TO THIS COMPLAINT. THIS LOT MET RELEASE REQUIREMENTS. THE UVADEX LOT NUMBER WAS NOT PROVIDED, SINCE NO UVADEX WAS ADMINISTERED. HOWEVER, A REVIEW OF ALL UVADEX LOTS MANUFACTURED SINCE JANUARY 2013 WAS PERFORMED. NO TRENDS OR NONCONFORMANCES RELATED TO THE COMPLAINT WERE NOTED. TRENDS WERE REVIEWED FOR COMPLAINT CATEGORIES, DRIVE TUBE LEAK/BREAK, ALARM #7: BLOOD LEAK? (CENTRIFUGE CHAMBER), AND ALARM #16: COLLECT PRESSURE. NO TRENDS WERE IDENTIFIED FOR THESE COMPLAINT CATEGORIES. A CORRECTIVE AND PREVENTIVE ACTION WAS INITIATED FOR COMPLAINT CATEGORY, DRIVE TUBE LEAK/BREAK. A CORRECTIVE AND PREVENTIVE ACTION WAS INITIATED FOR COMPLAINT CATEGORY, ALARM #16: COLLECT PRESSURE, AND IS NOW CLOSED. NO CORRECTIVE AND PREVENTIVE ACTION WAS INITIATED FOR COMPLAINT CATEGORY, ALARM #7: BLOOD LEAK? (CENTRIFUGE CHAMBER). SERVICE ORDER, (B)(4), WAS COMPLETED: THE SERVICE TECHNICIAN REPLACED THE LEAK DETECTOR STRIP AND TWO TUBE CLAMPS AND PERFORMED SUCCESSFUL SYSTEM CHECKOUT PROCEDURE. THIS ASSESSMENT IS BASED ON INFORMATION AVAILABLE AT THE TIME OF THE INVESTIGATION. NO PRODUCT WAS RETURNED BY THE CUSTOMER FOR INVESTIGATION; THEREFORE, IT COULD NOT BE DETERMINED IF THIS SPECIFIC PRODUCT MET SPECIFICATION. COMPLAINTS ARE MONITORED THROUGH TRACKING AND TRENDING. IF A TREND IS DETECTED, FURTHER INVESTIGATION WILL BE CONDUCTED THROUGH THE CAPA/CONTINUOUS IMPROVEMENT PROCESS. (B)(4). DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT DRIVE TUBE BREAK AND BLOOD LEAK DURING THE SINGLE NEEDLE MODE TREATMENT PROCEDURE. DUAL VORTEX PORT. A 5ML/MIN COLLECT RATE. A 10 THOUSAND UNIT HEPARIN USED AT 10:1 RATIO. MULTIPLE COLLECT PRESSURE ALARMS OCCURRED DUE TO ACCESS. CUSTOMER STATED THE CENTRIFUGE WAS SPINNING FOR THREE HOURS AND 12 MINUTES WHEN THE DRIVE TUBE BROKE. CENTRIFUGE LEAK ALARM OCCURRED. THE TREATMENT WAS ABORTED. CUSTOMER STATED THE DRIVE TUBE BROKE BETWEEN THE TWO BEARINGS. CUSTOMER DID NOT HAVE A PICTURE, AND THE KIT HAD ALREADY BEEN DISPOSED OF. PHYSICIAN WAS NOTIFIED. PATIENT WAS IN STABLE CONDITION. SERVICE ORDER, (B)(4), WAS DISPATCHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346377 THERAKOS CELLEX PHOTOPHERESISI SYSTEM CELLEX LNR THERAKOS INC. D311/625 - KIT

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR