BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERAKOS UVAR XTS

    MDR report key: 3747945 · Received January 22, 2014

    Report

    Report Number
    2523595-2014-00032
    Event Type
    Malfunction
    Date Received
    January 22, 2014
    Date of Event
    December 23, 2013
    Report Date
    December 23, 2013
    Manufacturer
    THERAKOS, INC.
    Product Code
    LNR
    PMA / PMN Number
    P680003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH RECORD REVIEW COULD NOT BE CONDUCTED BECAUSE LOT NUMBER WAS NOT PROVIDED. A FOLLOW-UP ATTEMPT WAS MADE TO OBTAIN A LOT NUMBER, BUT CTS REP WAS NOT ABLE TO OBTAIN THE INFO. COMPLAINT LOT REVIEW COULD NOT BE CONDUCTED SINCE NO LOT NUMBER PROVIDED. THE ASSESSMENT IS BASED ON INFO AVAILABLE AT THE TIME OF THE INVESTIGATION. THE INSTRUMENT PERFORMED AS INTENDED; HOWEVER, THE THERAKOS HAS ELECTED TO REPORT THIS INCIDENT DUE TO THE PT BEING ADMITTED AND TRANSFUSED. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT HE SUSPECTS DROP IN HEMATOCRIT IS DUE TO TREATMENT PROCEDURE WITH UVAR XTS INSTRUMENT. NAME AND FUNCTION OF COMPLAINANT: THERAKOS FIELD TRAINER (FTS) REPORTED ON BEHALF OF CUSTOMER. THERAKOS FTS EMAILED CTS TO REPORT ON BEHALF OF CUSTOMER SUSPICION OF A DROP IN THE HEMATOCRIT LEVELS OF A PT HAD BEEN OBSERVED OVER PERIOD OF MULTIPLE TREATMENT. PT RECEIVED TRANSFUSION ON (B)(6) 2013. STARTED TREATMENTS ON (B)(6) 2013, HGB 11.9. NEXT 2 TREATMENTS ON (B)(6) 2013, HGB 12.1. NEXT 2 TREATMENTS ON (B)(6) 2013, HGB 9.8. PT WAS SYMPTOMATIC AND WAS ADMITTED. COMPLAINED BEING LIGHT HEADED AND SHORT OF BREATH. VS STABLE. HE ALSO STATED THAT HE RAN A TEMP OF 100.3 ON (B)(6) 2013 BUT DID NOT TELL ANYONE. HE ALSO RECEIVED IVIG (B)(6) 2013. CUSTOMER DID NOT RETURN THE KIT FOR INVESTIGATION. FTS SPOKE WITH CUSTOMER AND DISCUSSED THE NEED TO DO A MANUAL RETURN OF RESIDUAL RED BLOOD CELLS FOLLOWING FREQUENT XTS ECP TREATMENTS IN ORDER TO MAINTAIN HEMATOCRIT. CURRENTLY THEY ARE NOT DOING THIS. FTS CONFIRMED THAT CUSTOMER HAS THE MOST RECENT COPY OF THE XTS OPERATOR'S MANUAL (REV J) AND THAT IT CONTAINS THE INSTRUCTIONS FOR MANUAL RETURN OF THE RESIDUAL RED BLOOD CELLS (BCS) TO MAINTAIN HEMATOCRIT. CUSTOMER STATED WILL TRY THIS METHOD WITH THE NEXT TREATMENT PROCEDURE. THEY WILL CALL AT THAT TIME IF THEY NEED FURTHER ASSISTANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53138 THERAKOS UVAR XTS XTS LNR THERAKOS, INC. 6660 UNKWN KIT

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention