BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERAKOS CELLEX PHOTOPHERESIS SYSTEM

    MDR report key: 5019578 · Received August 20, 2015

    Report

    Report Number
    2523595-2015-00215
    Event Type
    Injury
    Date Received
    August 20, 2015
    Date of Event
    July 25, 2015
    Report Date
    July 29, 2015
    Manufacturer
    THERAKOS, INC
    Product Code
    LNR
    UDI-DI
    10705030100009
    PMA / PMN Number
    P860003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE ORDER ((B)(4)) FEEDBACK RECEIVED: SERVICE ENGINEER REPLACED COLLECT, RETURN AND SYSTEM PRESSURE TRANSDUCERS, REPLACED RBC PUMP HEAD DUE TO STICKY ROLLER AND PERFORMED SYSTEM CHECKOUT PROCEDURE SUCCESSFULLY. (B)(4). DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 1

    SYSTEM WAS USED FOR TREATMENT. A BATCH RECORD REVIEW WAS PERFORMED FOR KIT LOT D322. THERE WERE NO NON-CONFORMANCES. THIS LOT MET ALL RELEASE REQUIREMENTS. 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 NONCOFORMANCES RELATED TO THE COMPLAINT WERE NOTED. TRENDS WERE REVIEWED FOR ALL COMPLAINT CATEGORIES AND NO TREND WAS DETECTED FOR ALARM #16: COLLECT PRESSURE, ALARM #17: RETURN PRESSURE, CLOT OBSERVED OR OTHER ADVERSE EVENT (TRANSIENT ISCHEMIC ATTACK (TIA)). HOWEVER, A CORRECTIVE AND PREVENTIVE ACTION WAS INITIATED FOR ALARM #16: COLLECT PRESSURE AND ALARM #17: RETURN PRESSURE AND IS NOW CLOSED. SERVICE ORDER (B)(4) FEEDBACK IS STILL PENDING AT THE TIME OF THIS REPORT AND WILL BE FILED IN A SUPPLEMENTAL REPORT WHEN AVAILABLE. THE ASSESSMENT IS BASED ON INFORMATION AVAILABLE AT THE TIME OF THE INVESTIGATION. FROM UVADEX PERSPECTIVE, THERE IS NO EVIDENCE TO SUGGEST A CAUSAL RELATIONSHIP BETWEEN THE DRUG AND THE ADVERSE EVENT AS UVADEX WAS NOT ADMINISTERED. THIS CASE IS SERIOUS, UNRELATED AND UNEXPECTED TO UVADEX. THIS IS NOT REPORTABLE FROM A DRUG PERSPECTIVE. THE ADVERSE EVENT, TRANSIENT ISCHEMIC ATTACK (TIA), IS RELATED TO THE PATIENT'S UNDERLYING CONDITION AS PER THE PATIENT'S PHYSICIAN STATEMENT. THE TIA IS NOT RELATED TO ECP TREATMENT. THE CLOT IN THE HEART IS ALSO UNRELATED TO ECP AS PER PATIENT'S PHYSICIAN. FROM A DEVICE PERSPECTIVE THIS EVENT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY NOR DID THE SYSTEM CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY BUT COULD HAVE MALFUNCTIONED IN A WAY THAT WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, IF THE MALFUNCTION WERE TO RECUR. THIS CASE HAS BEEN ASSESSED AS REPORTABLE AS THERE WAS CLOTTING IN THE RETURN LINE & THE PATIENT REQUIRED HOSPITALIZATION. (B)(4). DEVICE NOT RETURNED

    Description of Event or Problem · 1

    ON (B)(6) 2015, (B)(6) FEMALE WITH HISTORY OF HYPERCOAGULARITY, NHL, AML, STEM CELL TRANSPLANT, BRAIN RADIATION THERAPY AND GVHD OF UPPER GI TRACT HAD CLOTTING IN THE COLLECT AND RETURN LINES. PATIENT'S PRESSURE READINGS WERE HIGH. CUSTOMER STOPPED THE INSTRUMENT TO FLUSH THE ACCESS AND NOTED CLOTTING IN THE PORT ACCESS. CUSTOMER CONTACTED PATIENT PHYSICIAN, WHO AGREED TREATMENT SHOULD BE ABORTED WITH NO RETURN OF BLOOD/PRODUCTS TO THE PATIENT. CUSTOMER DISCONNECTED PATIENT ACCESS LINE AND WAS ATTEMPTING TO DRAW LAB SAMPLE. SHE ASKED PATIENT IF SHE WANTED SOMETHING TO DRINK AND NOTED PATIENT WAS NOT ABLE TO PROVIDE AN ANSWER. PATIENT HAD A TRANSIENT ISCHEMIC ATTACK (TIA). CUSTOMER CALLED RAPID RESPONSE WHO EVALUATED THE PATIENT AND CONTACTED NEUROLOGY. PATIENT WAS TAKEN TO THE ER AND ADMITTED TO THE HOSPITAL FOR FURTHER EVALUATION AND THEN DISCHARGED ON (B)(6) 2015. ACCORDING THE PATIENT'S PHYSICIAN THE TIA WAS BRIEF AND RESOLVED IN MINUTES. PATIENT WAS DISCHARGED. PATIENT WENT BACK TO THE HOSPITAL AND HAD OTHER MEDICAL TESTING. ECHOCARDIOGRAM FOUND CLOT IN RIGHT HEART AND PATENT OVALE(HOLE IN A PIECE TO THE ARTERIAL SIDE). PER THE PATIENT'S PHYSICIAN, THE TIA IS RELATED TO THE PATIENT'S PATENT OVALE. PATIENT IS ON HEPARIN. PATIENT WILL RESUME ECP AFTER PORT IS REPLACED. SERVICE ORDER (B)(4) WAS DISPATCHED. CUSTOMER DID NOT RETURN PRODUCT FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    550681 THERAKOS CELLEX PHOTOPHERESIS SYSTEM CELLEX LNR THERAKOS, INC D322 - KIT 10705030100009

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Hospitalization| R