BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERAKOS CELLEX PHOTOPHERESIS SYSTEM

    MDR report key: 3022800 · Received March 22, 2013

    Report

    Report Number
    2523595-2013-00018
    Event Type
    Injury
    Date Received
    March 22, 2013
    Date of Event
    February 18, 2013
    Report Date
    February 21, 2013
    Manufacturer
    THERAKOS
    Product Code
    LNR
    PMA / PMN Number
    P680003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT EXPERIENCED ADVERSE EVENTS WHILE TREATED WITH THE DEVICE, SINCE THE PATIENT RECEIVED TREATMENTS TO CONTROL THE SYMPTOMS (INCREASED BP) THIS SHOULD BE CONSIDERED AS MEDICAL INTERVENTION. THE EVENT WAS NOT DEVICE RELATED. (B)(4). THE ONLY MEDICATION REPORTED THAT THE PATIENT WAS TAKING AT THE TIME OF THE INCIDENT WAS HYDRALAZINE. OTHER MEDICATIONS: UNKNOWN BY REPORTER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN EPISODE OF HYPERTENSION IN A PATIENT THAT OCCURRED IN THE INITIAL 15 MINUTES OF THE TREATMENT. THE EVENT TOOK PLACE DURING THE WEEK OF THE (B)(6) 2013. COMPLAINT REPORTER: (B)(6) RN. ISSUE STARTED ON WEEK OF THE (B)(6) 2013. REPORTED ON (B)(6) 2013. THE PATIENT WAS A (B)(6) FEMALE WITH KNOWN CGD S/P BMT 40 DAYS AGO WITH ACUTE GVHD INC GI INVOLVEMENT NOT RESPONSIVE TO CSA, STEROIDS, AND CAMPATH. SHE HAS A HISTORY OF HYPERTENSION SECONDARY TO GVHD MEDICATIONS. BECAUSE OF THE ECP, HER MEDICATION WHICH WERE POTENTIALLY PHOTOSENSITIZING WERE CHANGED TO 7 AND REPORTEDLY HAVE BEEN ABLE TO CONTROL THE BP. THREE TIMES THIS WEEK, EACH TREATMENT HAD TO BE TERMINATED AFTER APPROXIMATELY 15 MINUTES DUE TO ELEVATED BP (DIASTOLICS OF 100+) ASSOCIATED WITH HEADACHE AND DIZZINESS REQUIRING ANTI-HYPERTENSIVE MEDICATIONS. THE BP IS EASILY CONTROLLED AND THE SYMPTOMS RESOLVE. THE PATIENT IS NOT FLUID OVERLOADED, IS NOT RECEIVING A PRIME, HAS NORMAL RENAL FUNCTION AND EVERY 3 HOUR BP ARE OTHERWISE REPORTEDLY NORMAL. THE PATIENT IS BEING TREATED WITH ACDA DUE TO GI GVHD AND BLEEDING. CUSTOMER CONTACTED THERAKOS MEDICAL AFFAIRS: HYPERTENSION HAS BEEN REPORTED IN THE PAST IN ASSOCIATION WITH RENAL DISEASE OR FLUID OVERLOAD AND NEVER, AS IN THIS CASE, IN THE FIRST 10-20 MINUTES OF THE PROCEDURE WHEN IF ANYTHING THE PATIENT IS SLIGHTLY AT A FLUID LOSS AND HAS ONLY BEEN EXPOSED TO SALINE AND ANTICOAGULANT. THE ECP TEAM'S PLAN IS TO HOLD THE ECP FOR SEVERAL DAYS AND TRY AGAIN AFTER THE WEEKEND. I ASKED (B)(6) TO LET ME KNOW IF THE PTN'S BP IS STABLE OVER THE NEXT FEW DAYS AND WHAT HAPPENS IF THEY OPT TO RE-TREAT. OTHER RELEVANT INFORMATION: THIS PATIENT RECEIVED 7 TREATMENTS UP TO DAY: 4 WITHOUT ANY PROBLEM, THE LAST 3 WITH THESE HYPERTENSION EPISODES. ASSOCIATED PROCEDURAL KIT: NOT PROVIDED. UVADEX DOSE: NONE AS THE TREATMENT WERE ALL STOPPED DUE TO THE HIGH BLOOD PRESSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119851 THERAKOS CELLEX PHOTOPHERESIS SYSTEM CELLEX ECP SYSTEM LNR THERAKOS 6661 NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Required Intervention