BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERAKOS CELLEX PHOTOPHERESIS SYSTEM

    MDR report key: 4892933 · Received July 6, 2015

    Report

    Report Number
    2523595-2015-00189
    Event Type
    Malfunction
    Date Received
    July 6, 2015
    Date of Event
    June 22, 2015
    Report Date
    June 22, 2015
    Manufacturer
    THERAKOS, INC
    Product Code
    LNR
    PMA / PMN Number
    P860003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IN THE INITIAL REPORT IT WAS STATED THAT THE PRODUCT RETURN INVESTIGATION WAS PENDING. THERAKOS MADE MULTIPLE ATTEMPTS TO GET THE CUSTOMER TO RETURN THE KIT FOR INVESTIGATION. THE PRODUCT WAS NEVER RECEIVED FROM THE CUSTOMER. HENCE, NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME FOR THIS EVENT. THIS COMPLAINT WILL BE CLOSED; IF ADDITIONAL INFORMATION IS RECEIVED, COMPLAINT WILL BE RE-OPENED AND INVESTIGATED ACCORDINGLY. (B)(4). DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 1

    SYSTEM WAS USED FOR TREATMENT. A BATCH RECORD REVIEW WAS PERFORMED FOR LOT D309. THERE WERE NO NON-CONFORMANCES. THIS LOT MET ALL RELEASE REQUIREMENTS. THE UVADEX LOT NUMBER WAS NOT PROVIDED AS IT WAS NOT ADMINISTERED. HOWEVER, A REVIEW OF ALL UVADEX LOTS MANUFACTURED SINCE JANUARY 2013 WAS PERFORMED. NO TRENDS OR NONCOFORMANCES RELATED TO THE COMPLAINT WERE NOTED. TRENDS WERE REVIEWED FOR ALL COMPLAINT CATEGORIES AND NO TREND WAS DETECTED FOR CENTRIFUGE BOWL LEAK/BREAK, ALARM #7: BLOOD LEAK? (CENTRIFUGE CHAMBER) NOR FOR SYSTEM ERROR. A CORRECTIVE AND PREVENTIVE ACTION HAS BEEN INITIATED AND IS ONGOING TO INVESTIGATE COMPLAINT CATEGORY CENTRIFUGE BOWL LEAK/BREAK. SERVICE ORDER (B)(4) COMPLETED: SERVICE ENGINEER CLEANED INSTRUMENT, REPLACED COLLECT PUMP HEAD BINDING ROLLERS AND PERFORMED SYSTEM CHECKOUT TEST SUCCESSFULLY. NO FURTHER ACTION REQUIRED. THE ASSESSMENT IS BASED ON INFORMATION AVAILABLE AT THE TIME OF THE INVESTIGATION. NO PRODUCT HAS BEEN RECEIVED FOR INVESTIGATION AT THE TIME OF THIS REPORT. ONCE THE KIT IS RECEIVED FOR INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETE. (B)(4). DEVICE NOT YET RECEIVED FOR EVALUATION.

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT BLOOD LEAK IN CENTRIFUGE FOLLOWED BY SYSTEM ERROR 130. CUSTOMER STATED CENTRIFUGE LEAK DETECTOR STRIP WAS DAMAGED AND THERE WAS BLOOD IN THE CENTRIFUGE. CUSTOMER STATED DRIVE TUBE AND CENTRIFUGE BOWL WERE BOTH STILL INTACT SO THEY COULD NOT FIND THE SOURCE OF THE BLOOD LEAK. A 1100 ML WHOLE BLOOD PROCESSED. CLINICAL SERVICES SPECIALIST (CSS) ASKED CUSTOMER IF ANYONE WAS SPLASHED WITH BLOOD/FLUIDS DUE TO THE LEAK, CUSTOMER STATED NO ONE WAS SPLASHED WITH BLOOD AS THE LEAK WAS CONTAINED WITHIN THE CENTRIFUGE. CSS ASKED CUSTOMER IF THERE WERE ANY ALARMS DURING PRIME, CUSTOMER STATED NO THERE WERE NO ALARMS DURING PRIME. CUSTOMER STATED THERE WAS ONE RED BLOOD CELL PUMP ALARM AT 500 ML WHOLE BLOOD PROCESSED. CUSTOMER STATED SHE CLEARED THE ALARM BY STOPPING AND REPURGING. CSS ASKED CUSTOMER IF DRIVE TUBE AND CENTRIFUGE BOWL WERE REMOVED AT ANY TIME WHEN THE INSTRUMENT WAS STOPPED, CUSTOMER STATED NOTHING WAS UNLOADED. CUSTOMER STATED SHE WAS ABLE TO CONTINUE WITH THE PROCEDURE TILL BLOOD LEAK ALARM OCCURRED. CSS ASKED CUSTOMER IF THERE WAS ANY CLOTTING OR OCCLUSIONS NOTED IN THE PROCEDURE. CUSTOMER STATED NO THERE WAS NO CLOTTING OR OCCLUSIONS NOTED IN ANY PART OF THE KIT. CSS ASKED CUSTOMER IF PATIENT IS ALRIGHT, CUSTOMER STATED PATIENT WAS STABLE. SERVICE ORDER (B)(4) WAS DISPATCHED. CUSTOMER WILL RETURN THE KIT FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435981 THERAKOS CELLEX PHOTOPHERESIS SYSTEM CELLEX LNR THERAKOS, INC D309 - KIT

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR