BEUDAMED
    FDA Adverse Event Other Summary report: N

    THERAKOS UVAR XTS PHOTPHERESIS SYSTEM

    MDR report key: 3452830 · Received October 28, 2013

    Report

    Report Number
    2523595-2013-00155
    Event Type
    Other
    Date Received
    October 28, 2013
    Date of Event
    September 5, 2013
    Report Date
    September 5, 2013
    Manufacturer
    THERAKOS, INC.
    Product Code
    LNR
    PMA / PMN Number
    P680003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF LOT B701 WAS PERFORMED. THERE WERE NO NON CONFORMANCES ASSOCIATED WITH THIS LOT. THIS LOT MET ALL RELEASE REQUIREMENTS. SERVICE ORDER FEEDBACK FOR (B)(4): FIELD ENGINEER INSTALLED A NEW ROCKER MOTOR. HE CALIBRATED THE THERMOCOUPLES AND COMPLETED THE SECTION 7 CHECKOUT. REPAIRS HAVE RETURNED THIS INSTRUMENT TO EXPECTED OPERATION. A REVIEW OF COMPLAINTS RECEIVED FOR LOT B701 WAS PERFORMED. THERE WERE NO OTHER SYSTEM ERROR 204 OR 285 ALARMS REPORTED TO DATE FOR THIS LOT. NO PRODUCT WAS RETURNED BY THE CUSTOMER FOR INVESTIGATION. THEREFORE, THE ROOT CAUSE FOR THE ALARMS CANNOT BE DETERMINED BASED SOLELY ON THE INFO RECEIVED BY THE CUSTOMER. HOWEVER, THE ROCKER MOTOR WAS REPLACED TO PREVENT FUTURE RECURRENCE OF THIS ALARM. THE OPERATOR ACTED CORRECTLY IN ABORTING THE TREATMENT AND RETURNING ALL BLOOD/BLOOD PRODUCTS TO THE PATIENT. THE OPERATOR ELECTED TO SUCCESSFULLY RETREAT THE PATIENT IMMEDIATELY FOLLOWING THE ABORTED TREATMENT ON ANOTHER INSTRUMENT. AFTER THIS TREATMENT THE PATIENT HEMATOCRIT FELL FROM 27.0% ON (B)(6) 2013 TO 21.8% AND THE HEMOGLOBIN FROM 8.7 TO 7.1 G/DL. DUE TO THESE LAB VALUES, A TRANSFUSION WAS PERFORMED. PLEASE REFER TO CAPA (B)(4) FOR LATE REPORTING JUSTIFICATION. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER CALLED, INITIALLY, TO REPORT SYSTEM ERROR F204 DURING PHOTOACTIVATION. CUSTOMER STATED ALARM F204 OCCURRED SO SHE POWERED OFF THE INSTRUMENT, CHECKED TO MAKE SURE THE PHOTOPLATE WAS ON PROPERLY. CUSTOMER THEN POWERED ON THE INSTRUMENT AND GOT A SYSTEM ERROR 285. CTS INFORMED CUSTOMER THAT THE PROCEDURE HAS BEEN ABORTED AND ALL BLOOD/PRODUCTS WILL HAVE TO BE RETURNED MANUALLY. CUSTOMER AGREED TO DO SO. (B)(4) WAS DISPATCHED TO INSPECT THE INSTRUMENT. CUSTOMER CALLED BACK ON (B)(6) 2013 TO REPORT THIS PATIENT WILL RECEIVE AN UNPLANNED TRANSFUSION. CUSTOMER STATED SHE MANUALLY RETURNED ALL BLOOD/PRODUCTS TO PATIENT DUE TO THE TREATMENT PROCEDURE BEING ABORTED. CUSTOMER STATE SHE WAS ABLE TO RETURN ALL BUT APPROX. 100ML OF BLOOD/BLOOD PRODUCTS TO THE PATIENT. CUSTOMER STATED SHE THEN CHOSE TO RETREAT THE PATIENT IMMEDIATELY ON A DIFFERENT INSTRUMENT. THIS PROCEDURE COMPLETED SUCCESSFULLY. CUSTOMER STATED SHE DREW A CBC AFTER THE COMPLETION OF THE SUCCESSFUL TREATMENT PROCEDURE. THE HEMATOCRIT RESULT WAS 21.8%. THUS A TRANSFUSION WAS ORDERED FOR THIS PATIENT. CTS ASKED IF THE PATIENT COMPLAINED OF ANY SYMPTOMS PRIOR TO, DURING OR AFTER THE TREATMENT PROCEDURE. CUSTOMER STATED NO, THE PATIENT DID NOT HAVE ANY COMPLAINTS AT ANY TIME. THE CUSTOMER DID NOT RETURN ANY PRODUCT FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551381 THERAKOS UVAR XTS PHOTPHERESIS SYSTEM UVAR XTS ECP SYSTEM LNR THERAKOS, INC. 6660 B701 KIT

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention