BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERAKOS CELLEX PHOTOPHERESIS SYSTEM

    MDR report key: 2930348 · Received January 22, 2013

    Report

    Report Number
    2523595-2013-00005
    Event Type
    Injury
    Date Received
    January 22, 2013
    Date of Event
    December 5, 2012
    Report Date
    December 19, 2012
    Manufacturer
    THERAK RARITAN
    Product Code
    LNR
    PMA / PMN Number
    P680003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION AVAILABLE TODAY AND ON CUSTOMER STATEMENT THAT CHILDREN REACTS TO FLUID SHIFT (THEREFORE INDEPENDENTLY TO THE DRUG) THIS ADVERSE EVENT HAS BEEN ASSESSED BY MEDICAL AFFAIRS AS DEVICE RELATED AND THEREFORE REPORTABLE UNDER THE DEVICE (30 DAYS) REGULATION. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CALLED TO REPORT THAT AFTER AN ECP TREATMENT, THE PATIENT SUFFERED FROM AN EPISODE OF CRAMPING. ISSUE STARTED ON: (B)(6) 2012. REPORTED ON (B)(4) 2012. CLXECP (B)(4). THE INSTRUMENT WAS SET IN DOUBLE NEEDLE MODE FLUID BALANCE AT END OF TREATMENT +446 ML. HEPARIN USED AS A/C. REINFUSION OF BC AT 5 ML/MIN. THE PATIENT HAD ANOTHER EPISODE OF CRAMPING 12 HRS LATER AFTER RECEIVING ECP. NEXT-DAY ECP TREATMENT WAS CANCELLED. THE CUSTOMER COULD NOT PROVIDE ANY MORE DETAILS AT THE TIME SINCE THEY WERE NOT PRESENT WHEN THIS HAPPENED. THE CUSTOMER DID NOT THINK THAT THE EPISODES WERE NECESSARILY LINKED TO ECP. ADDITIONAL INFORMATION RECEIVED ON (B)(4) 2012: CUSTOMER CONFIRMED THAT THE PATIENT SUFFERED FROM A CEREBRAL SEIZURE. LAST TREATMENT (4TH TREATMENT IN TOTAL) WAS (B)(6) 2012 - NO ISSUES, BUT THIS PATIENT WILL NO LONGER BE TREATED BY ECP, BECAUSE IT IS CONSIDERED THAT THE PSYCHOLOGICAL STRESS FOR THE BOY AND HIS FAMILY IS TOO MUCH. DURING TREATMENT, THE PATIENT REACTS TO FLUID SHIFTS WITH A HEADACHE WHICH INDICATES INCREASED PRESSURE IN THE BRAIN. WHEN THIS OCCURS, PATIENT WILL START SCREAMING AND WORK HIMSELF INTO A STATE OF HYSTERIA. INFORMATION RECEIVED ON (B)(4) 2012: CEREBRAL SEIZURE OCCURRED ONCE ONLY, AFTER TREATMENT. DURING TREATMENT, CHILD PATIENT REACTED TO FLUID SHIFTS WITH A HEADACHE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30091 THERAKOS CELLEX PHOTOPHERESIS SYSTEM CELLEX ECP SYSTEM LNR THERAK RARITAN 6661 A113

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Other