BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERAKOS CELLEX PHOTOPHERESIS SYSTEM

    MDR report key: 4360453 · Received December 19, 2014

    Report

    Report Number
    2523595-2014-00330
    Event Type
    Injury
    Date Received
    December 19, 2014
    Date of Event
    November 26, 2014
    Report Date
    December 1, 2014
    Manufacturer
    THERAKOS, INC.
    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

    BATCH RECORD REVIEW OF LOT C347 WAS PERFORMED. THERE WERE NO NONCONFORMANCES ASSOCIATED WITH THIS LOT. THIS LOT MET RELEASE REQUIREMENTS. A REVIEW OF LOT C347 SHOWS NO TRENDS. TRENDS WERE REVIEWED FOR COMPLAINT CATEGORIES, FEVER AND PULMONARY EMBOLISM AND NO TRENDS WERE DETECTED. THERE WERE NO CAPAS INITIATED. THE PATIENT WAS HOSPITALIZED AND REQUIRED MEDICAL INTERVENTION. THIS CASE IS SERIOUS AND UNRELATED TO TREATMENT. IT IS UNLIKELY THAT ECP THERAPY TRIGGERED THE PULMONARY EMBOLISM. THIS ASSESSMENT IS BASED ON INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. NO PRODUCT WAS RETURNED FOR EVALUATION; THEREFORE, IT COULD NOT BE DETERMINED IF THIS SPECIFIC PRODUCT MET SPECIFICATIONS. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER CALLED TO ASK IF ECP IS CONTRAINDICATED FOR A PATIENT WHO WAS PREVIOUSLY ADMITTED FOR A PULMONARY EMBOLISM AND IS CURRENTLY ON A HEPARIN DRIP. CUSTOMER UNDERSTANDS HEPARIN IS NORMALLY USED DURING ECP TREATMENT. THERAKOS MEDICAL AFFAIRS DEPARTMENT WAS NOTIFIED AND CALLED CUSTOMER BACK TO ADVISE. THE CUSTOMER WAS ASKED IF THE PATIENT HAD RECEIVED ANY ECP TREATMENTS PRIOR TO THE PULMONARY EMBOLISM BEING DIAGNOSED. CUSTOMER STATED THE PATIENT HAD RECEIVED A TOTAL OF 15 ECP TREATMENTS. CUSTOMER REPORTED THE LAST ECP TREATMENT WAS A SINGLE NEEDLE MODE TREATMENT ON (B)(6) 2014. CUSTOMER STATED THE PATIENT WENT HOME AFTER THE LAST ECP TREATMENT THEN DEVELOPED A FEVER THAT NIGHT SO SHE RETURNED TO THE HOSPITAL, WHERE SHE WAS DIAGNOSED WITH THE FLU AND WITH A PULMONARY EMBOLISM. SHE WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2014. CUSTOMER STATED THE EXACT DOSE OF HEPARIN USED FOR THE ECP TREATMENT ON (B)(6) 2014 WAS NOT RECORDED, BUT THEY HAVE DOCUMENTED THAT 7720 UNITS OF HEPARIN HAD BEEN USED FOR THE PATIENT'S PREVIOUS ECP TREATMENT ON (B)(6) 2014. CUSTOMER REPORTED PATIENT IS STABLE AS OF (B)(6) 2014, AS THEY ARE CONSIDERING ADMINISTERING ANOTHER ECP TREATMENT TODAY ((B)(6) 2014). THE CUSTOMER DOES NOT BELIEVE THAT THE EVENT WAS RELATED TO THE ADMINISTRATION OF UVADEX AND THE CUSTOMER CONSIDERS THE EVENT TO BE SERIOUS. CUSTOMER ALSO REPORTED THAT THE PATIENT RECEIVED A TRANSFUSION WHILE SHE WAS ADMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    836630 THERAKOS CELLEX PHOTOPHERESIS SYSTEM CELLEX LNR THERAKOS, INC. C347

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R