BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERAKOS CELLEX PHOTOPHERESIS SYSTEM

    MDR report key: 4903263 · Received July 9, 2015

    Report

    Report Number
    2523595-2015-00201
    Event Type
    Injury
    Date Received
    July 9, 2015
    Date of Event
    June 25, 2015
    Report Date
    June 25, 2015
    Manufacturer
    THERAKOS, INC
    Product Code
    LNR
    PMA / PMN Number
    P860003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM WAS USED FOR TREATMENT. A BATCH RECORD REVIEW OF KIT LOT D319 WAS CONDUCTED. THERE WERE NO NONCONFORMANCES ASSOCIATED WITH THIS LOT. THE LOT MET RELEASE REQUIREMENT. THE UVADEX LOT NUMBER WAS NOT PROVIDED AS IT WAS NOT ADMINISTERED. HOWEVER, A REVIEW OF ALL UVADEX LOTS MANUFACTURED SINCE JANUARY 2013 WAS PERFORMED. NO TRENDS OR NONCONFORMANCES RELATED TO THE COMPLAINT WERE NOTED. TRENDS WERE REVIEWED FOR COMPLAINT CATEGORIES, FEVER AND INFECTION. NO TRENDS WERE DETECTED FOR THESE COMPLAINT CATEGORIES. NO CORRECTIVE AND PREVENTIVE ACTION WAS INITIATED FOR COMPLAINT CATEGORIES, FEVER AND INFECTION. BASED ON THE MEDICAL ASSESSMENT, A (B)(6) YEAR OLD MALE WITH CTCL HAD POOR VENOUS ACCESS CARE PRIOR TO THE START OF THE ECP PROCEDURE. THE PATIENT'S STARTING TEMPERATURE WAS 98.6 DEGREES WITH A BLOOD PRESSURE OF 147/65 MMHG. AFTER THE TREATMENT, THE PATIENT HAD A TEMPERATURE OF 102.2 DEGREES WITH A BLOOD PRESSURE OF 114/65. THE PATIENT STATED THAT HE WAS NOT FEELING WELL WITH NO UVADEX ADMINISTERED. THE PATIENT WAS GIVEN ANTIBIOTICS. VENOUS ACCESS PAIN, INFECTION, AS WELL AS TRANSIENT PYRETIC REACTION ARE ALL KNOWN SIDE EFFECTS OF THE ECP PROCEDURE. HOWEVER, THE OPERATOR STATES "CUSTOMER STATED PATIENT NON COMPLIANT VASCULAR ACCESS CARE"; IS THE LIKELY THE CAUSE OF THESE ADVERSE EVENTS. FROM A UVADEX PERSPECTIVE, THERE IS NO EVIDENCE TO SUGGEST A CAUSAL RELATIONSHIP BETWEEN THE DRUG AND THE ADVERSE EVENTS AS IT WAS NOT ADMINISTERED. THIS CASE IS SERIOUS, UNRELATED AND UNEXPECTED FOR UVADEX. THIS IS NOT REPORTABLE FROM A DRUG PERSPECTIVE. FROM A DEVICE PERSPECTIVE THIS EVENT DID NOT CAUSE OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY; AND OR THE SYSTEM DID NOT CAUSE OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY NOR MALFUNCTION IN A WAY THAT WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, IF THE MALFUNCTION WERE TO RECUR. THERE WAS NO DEVICE MALFUNCTION. THE ADVERSE EVENT IS RELATED TO THE PATIENT'S UNDERLYING CONDITION OF POOR VENOUS ACCESS CARE WHICH CAUSED THE MEDICAL INTERVENTION TO OCCUR. THE PATIENT WAS HOSPITALIZED ON (B)(6) 2015 AND DISCHARGED ON (B)(6) 2015. SINCE THE EVENT HAPPENED DURING TREATMENT AND MEDICAL INTERVENTION WAS NECESSARY, THIS CASE IS REPORTABLE AS AN MDR. THE ASSESSMENT IS BASED ON INFORMATION AVAILABLE AT THE TIME OF THE INVESTIGATION. NO PRODUCT WAS RETURNED FOR INVESTIGATION; THEREFORE, IT COULD NOT BE DETERMINED IF THE PRODUCT MET SPECIFICATION BASED SOLELY ON THE INFORMATION PROVIDED BY THE CUSTOMER. COMPLAINTS ARE MONITORED THROUGH TRACKING AND TRENDING. IF A TREND IS DETECTED, FURTHER INVESTIGATION WILL BE CONDUCTED THROUGH THE CAPA/CONTINUOUS IMPROVEMENT PROCESS. (B)(4). DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    THE CUSTOMER CALLED TO REPORT THAT THE PATIENT WAS NOT FEELING WELL, SO THE PHYSICIAN HAS STOPPED THE TREATMENT PROCEDURE. THE CUSTOMER STATED THAT THEY HAVE COMPLETED THE BUFFY COAT COLLECTION, BUT HAD NOT STARTED PHOTOACTIVATION OR ADMINISTERED UVADEX. THE CUSTOMER WANTED TO KNOW HOW TO STOP THE PROCEDURE AND RETURN THE BLOOD/FLUID BACK TO THE PATIENT. THE CUSTOMER STATED THAT THE PATIENT HAD A FEVER AND A POSSIBLE INFECTION DUE TO POOR CARE OF THEIR VASCULAR ACCESS SITE. THE CUSTOMER STATED THAT THE PATIENT WAS IN STABLE CONDITION. THE CUSTOMER STATED THAT SHE DID NOT SEE ANY CLOTTING, OCCLUSIONS, OR FLUID LEAKS. THE CUSTOMER ENDED THE TREATMENT SUCCESSFULLY. THE PATIENT WAS GIVEN ANTIBIOTICS AND MAY BE ADMITTED TO THE HOSPITAL, IF THE PATIENT AGREES. THE CUSTOMER STATED THAT THE PATIENT HAD BEEN NON COMPLIANT IN HIS VASCULAR ACCESS CARE. THE CUSTOMER STATED THAT THERE WERE NO ALARMS THROUGHOUT THE PROCEDURE OR DURING THE PRIMING OF THE KIT. ON (B)(6) 2015, THE CUSTOMER STATED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2015 AND WAS DISCHARGED ON (B)(6) 2015. THE CUSTOMER HAS ELECTED NOT TO RETURN THE KIT FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448066 THERAKOS CELLEX PHOTOPHERESIS SYSTEM CELLEX LNR THERAKOS, INC D319-KIT

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R