BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERAKOS CELLEX PHOTOPHERESIS SYSTEM

    MDR report key: 2833148 · Received November 14, 2012

    Report

    Report Number
    2523595-2012-00066
    Event Type
    Injury
    Date Received
    November 14, 2012
    Date of Event
    August 31, 2012
    Report Date
    October 24, 2012
    Manufacturer
    THERAKOS
    Product Code
    LNR
    PMA / PMN Number
    P680003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW UP WITH THE CUSTOMER ON 05 DECEMBER 2012: PATIENT WAS TREATED ONCE SINCE EVENT WAS REPORTED (1 TREATMENT/MONTH). PATIENT WAS ADMINISTERED HYDROCORTISONE + PIRITON IV PRIOR TO ECP TREATMENT: NO SYMPTOMS OCCURRED. THIS INFO DOES NOT CHANGE THE INITIAL ASSESSMENT. MXP: 31735959; QERTS: 273809.

    Additional Manufacturer Narrative · 0

    THE ETIOLOGY OF THE PATIENT'S SYMPTOMS ARE NOT CLEAR. THE SYMPTOMS APPEAR TO BE TEMPORALLY ASSOCIATED WITH THE RE-INFUSION OF THE BUFFY COAT CELLS WHICH CONTAINS TREATED CELLS, UNACTIVATED METHOXYPSORALEN, PLASMA, HEPARIN AND POTENTIALLY ETHYLENE OXIDE. THE DIZZINESS, LIGHTHEADEDNESS AND FLUSHING SENSATION WITHOUT A CHANGE IN BLOOD PRESSURE EXPERIENCED BY THE PATIENT ON MORE THAN ONE OCCASION WOULD BE UNUSUAL FOR AN ALLERGIC REACTION. WHILE WE CANNOT RULE OUT AN ALLERGIC REACTION TO METHOXYPSORALEN, THE SYMPTOMS ARE SUGGESTIVE OF A SEROTONIN-LIKE RELEASE SYNDROME WITH THE PATIENT'S PLATELETS BEING A POSSIBLE SOURCE. WE HAVE ASKED THE TREATING HCP IF HE HAS CONSIDERED THIS POSSIBILITY AND HAVE NOT RECEIVED A RESPONSE FROM THE SITE TO DATE. (B)(4). QERTS: 267310.

    Description of Event or Problem · 0

    CUSTOMER IS COMPLAINING ABOUT: LIGHT-HEADEDNESS/ DIZZINESS 'DURING TREATMENT. ISSUE STARTED IN AUGUST 2012, DURING 11TH TREATMENT OF THIS PATIENT. REPORTED ON 24-0CT-2012, AT THE SAME TIME AS MOST RECENT EVENT REPORTED FOR THIS PATIENT, SEE (B)(4). 2.4 ML UVADEX ADMINISTERED. AFTER THIS EVENT, PATIENT WAS ADMINISTERED HYDROCORTISONE + PIRITON IV PRIOR TO ECP TREATMENT: CUST FELL ASLEEP DURING TREATMENT, NO SYMPTOMS. PATIENT REQUESTED NOT TO GET HYDROCORTISONE + PIRITON IV AGAIN, BUT THAT REINFUSION RATE BE LOWERED FOR NEXT ECP. NO MORE DETAILS PROVIDED. CELLEX SYSTEM SERIAL NUMBER UNKNOWN. AT THE TIME, OPERATORS ATTRIBUTED THE SYMPTOMS TO PATIENT ANXIETY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224141 THERAKOS CELLEX PHOTOPHERESIS SYSTEM CELLEX ECP SYSTEM LNR THERAKOS 6661 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female Other