BEUDAMED
    FDA Adverse Event Other Summary report: N

    THERAKOS CELLEX PHOTOPHERESIS SYSTEM

    MDR report key: 3662921 · Received January 24, 2014

    Report

    Report Number
    2523595-2014-00033
    Event Type
    Other
    Date Received
    January 24, 2014
    Date of Event
    December 26, 2013
    Report Date
    December 26, 2013
    Manufacturer
    THERAKOS, INC.
    Product Code
    LNR
    PMA / PMN Number
    P680003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH RECORD REVIEW OF LOT B340 WAS CONDUCTED. THERE WERE NO NON CONFORMANCES RELATED TO THIS ISSUE FOR THIS LOT. LOT MET RELEASE REQUIREMENTS. COMPLAINT LOT REVIEW CONDUCTED AND ONE ADDITIONAL C ADVERSE EVENT WAS REPORTED TO DATE WHEN USING THIS LOT. NO TRENDS DETECTED. THE ASSESSMENT IS BASED ON INFO AVAILABLE AT THE TIME OF THE INVESTIGATION. THE INSTRUMENT PERFORMED AS INTENDED, AND EVEN THOUGH A LOW HEMATOCRIT OR HEMOGLOBIN CAN BE SECONDARY TO THE UNDERLYING DISEASE OR FREQUENT ECP TREATMENTS; A DEFINITE ROOT CAUSE COULD NOT BE DETERMINED; HOWEVER, THERAKOS HAS ELECTED TO REPORT THIS INCIDENT DUE TO THE PT'S TRANSFUSION. MXP (B)(4).

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT PT HAD AN ADVERSE REACTION DURING A TREATMENT PROCEDURE WITH CELLEX INSTRUMENT. NAME AND FUNCTION OF COMPLAINANT: SAME AS REPORTER. CUSTOMER STATED THEY DREW A CBC LAB AND STARTED THE PT TREATMENT, DURING THE TREATMENT, THE PT STATED SHE FELT STRANGE, THE PRESCRIBING PHYSICIAN EVALUATED THE PT AND DETERMINED SHE WAS FINE. CUSTOMER STATED WHEN THEY RECEIVED THE STAT CBC BACK, THE PT HEMATOCRIT WAS AT (B)(6)% AT WHICH POINT THE CUSTOMER ENDED THE TREATMENT AND RETURNED THE BLOOD BACK TO THE PT. CUSTOMER STATED THE PT RECEIVED TWO (2) UNITS OF BLOOD AND WILL BE RE-SCHEDULED NEXT WEEK FOR HER ECP TREATMENT. PT IS STABLE. CUSTOMER DID NOT RETURN THE KIT FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56033 THERAKOS CELLEX PHOTOPHERESIS SYSTEM CELLEX LNR THERAKOS, INC. 6661 B340 KIT

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention