BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERAKOS CELLEX PHOTOPHERESIS SYSTEM

    MDR report key: 4883109 · Received July 1, 2015

    Report

    Report Number
    2523595-2015-00197
    Event Type
    Malfunction
    Date Received
    July 1, 2015
    Date of Event
    June 17, 2015
    Report Date
    June 17, 2015
    Manufacturer
    THERAKOS, INC
    Product Code
    LNR
    PMA / PMN Number
    P860003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM WAS USED FOR TREATMENT. A BATCH RECORD REVIEW OF KIT LOT D302 WAS CONDUCTED. THERE WERE NO NONCONFORMANCES ASSOCIATED WITH THIS LOT. THE LOT MET 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 COMPLAINT CATEGORIES, DRIVE TUBE LEAK/BREAK, NOISE, AND SYSTEM ERROR. NO TRENDS WERE DETECTED FOR THESE COMPLAINT CATEGORIES. HOWEVER, CORRECTIVE AND PREVENTIVE ACTIONS WERE ALREADY INITIATED FOR COMPLAINT CATEGORIES, DRIVE TUBE LEAK/BREAK AND NOISE. NO CORRECTIVE AND PREVENTIVE ACTION WAS INITIATED FOR COMPLAINT CATEGORY, SYSTEM ERROR. SERVICE ORDER, (B)(4), FEEDBACK: THE SERVICE TECHNICIAN REPLACED THE CENTRIFUGE LEAK STRIP AND CLEANED THE BLOOD FROM THE AREAS THAT THE CUSTOMER COULD NOT GET TO. THE TECHNICIAN EXAMINED THE BOWL OPTIC ASSEMBLY AND SUCCESSFULLY COMPLETED THE SYSTEM CHECKOUT PROCEDURE. THIS ASSESSMENT IS BASED ON INFORMATION AVAILABLE AT THE TIME OF THE INVESTIGATION. THE ANALYSIS OF THE KIT IS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE FILED WHEN THE ANALYSIS IS COMPLETE. (B)(4).

    Additional Manufacturer Narrative · 1

    THE KIT AND SMARTCARD WERE RETURNED FOR ANALYSIS. THE DATA INDICATED THAT THE PRIME WAS COMPLETED. AFTER 148ML OF WHOLE BLOOD PROCESSED, A BLOOD LEAK ALARM OCCURRED AND THE TREATMENT WAS ABORTED. A SYSTEM ERROR #130 (BOWL LEAK SENSOR FAULT) WAS SEEN WHEN THE INSTRUMENT WAS POWERED ON AGAIN AFTER CLEANING. UPON EXAMINATION OF THE KIT, THE DRIVE TUBE WAS FOUND TO BE IN TWO PIECES. NEITHER BEARING STOP MOVED WHEN PULLED, THUS ELIMINATING BEARING STOP DELAMINATION AS THE CAUSE. THE CENTRIFUGE BOWL SHOWED SIGNS THAT IT HAD COME IN CONTACT WITH SOMETHING INSIDE THE CENTRIFUGE CHAMBER, AND TWO OF THE FOUR LOCATING TABS WERE BENT. ALL THE TABS SHOWED SIGNS OF SOME DAMAGE AND THERE WERE SCUFFS ON A SECTION AT THE BASE OF THE BOWL. CRACKS IN THE BASE OF THE BOWL WERE ALSO SEEN IN THE SAME AREA AS THE SCUFF MARKS. THIS TYPE OF BOWL OUTER DAMAGE USUALLY INDICATES THE BOWL HAD BECOME DISLODGED FROM THE PLATEN, AND THEN CAME IN CONTACT WITH OTHER PARTS WITHIN THE INSTRUMENT. THE DISLODGED BOWL IS LIKELY THE CAUSE FOR BOTH THE LEAK DETECTOR STRIP DAMAGE AND THE DRIVE TUBE BREAK. THE ONLY WAY FOR THE BOWL TO DISLODGE FROM THE PLATEN, FULLY INTACT, IS IF THE LOCATING TABS WERE NOT PROPERLY LOCKED INTO THEIR FIXTURE. NO MANUFACTURING DEFECTS WERE IDENTIFIED DURING THE REVIEW. THE DHR REVIEW OF THE COMPLAINT LOT FOUND NO RELATED NONCONFORMANCES. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DRIVE TUBE WAS SEVERED JUST ABOVE THE LOWER DRIVE TUBE BEARING; RESULTING IN A BLOOD LEAK IN THE CENTRIFUGE. THE CUSTOMER REPORTED THAT THE BOWL ALSO CAME OUT OF THE BOWL HOLDER, HOWEVER THE BOWL DID NOT BREAK. THE CUSTOMER REPORTED THAT THE TREATMENT WAS ABORTED AND THE REMAINING BLOOD IN THE KIT WAS NOT RETURNED TO THE PATIENT. THE CUSTOMER STATED THAT THE PATIENT WAS AN OUT-PATIENT, AND WAS STABLE. THE CUSTOMER STATED THAT THE CENTRIFUGE LEAK SENSOR STRIP WAS DAMAGED, AND THAT NO ALARMS HAD OCCURRED PRIOR TO THE DRIVE TUBE BREAK. THE CUSTOMER NOTICED A NOISE WHICH WAS DESCRIBED AS A VIBRATION JUST BEFORE THE DRIVE TUBE BREAK. THE CUSTOMER STATED THAT SHE HAD ALREADY DONE A PRELIMINARY CLEANING OF THE CENTRIFUGE, HOWEVER A SYSTEM ERROR 130 OCCURRED WHEN SHE POWERED ON THE INSTRUMENT. THE CUSTOMER WAS ADVISED THAT THIS SYSTEM ERROR WAS CAUSED BY THE DAMAGED LEAK SENSOR STRIP. SERVICE ORDER, (B)(4), WAS DISPATCHED TO REPLACE THE LEAK STRIP AND PERFORM A THOROUGH CLEANING OF THE CENTRIFUGE. THE KIT WAS RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425987 THERAKOS CELLEX PHOTOPHERESIS SYSTEM CELLEX LNR THERAKOS, INC D302-KIT

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR