BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERAKOS CELLEX PHOTOPHERESIS SYSTEM

    MDR report key: 5032474 · Received August 26, 2015

    Report

    Report Number
    2523595-2015-00229
    Event Type
    Injury
    Date Received
    August 26, 2015
    Date of Event
    August 12, 2015
    Report Date
    August 13, 2015
    Manufacturer
    THERAKOS, INC
    Product Code
    LNR
    PMA / PMN Number
    P860003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM WAS USED FOR TREATMENT. A BATCH RECORD REVIEW OF KIT LOT D326 WAS CONDUCTED. THERE WERE NO NONCONFORMANCES ASSOCIATED WITH THIS LOT. THE LOT MET RELEASE REQUIREMENTS. UVADEX LOT# AD1437 WAS REVIEWED. NO TRENDS OR NONCONFORMANCES RELATED TO THE COMPLAINT WERE NOTED. TRENDS WERE REVIEWED FOR COMPLAINT CATEGORIES, VOMITING AND VASOVAGAL REACTION. NO TRENDS WERE DETECTED FOR THESE COMPLAINT CATEGORIES. NO CORRECTIVE AND PREVENTIVE ACTION WAS INITIATED FOR COMPLAINT CATEGORIES, VOMITING AND VASOVAGAL REACTION. BASED ON THE INTERNAL MEDICAL ASSESSMENT, A MALE CHILD PATIENT WITH A HCT BEFORE TREATMENT OF 25.9% HAD AN ADVERSE EVENT DURING THE BUFFY COAT PHASE OF THE TREATMENT. THE PATIENT HAD A BLOOD PRIME. THE PATIENT STOOD UP TO GO TO THE BATHROOM, AND THE NURSES NOTED PALOR, VOMITING, AND UNSTEADINESS. THE PATIENT WAS BROUGHT BACK TO THE BED AND GIVEN 100ML SALINE BOLUS THROUGH THE INSTRUMENT FOLLOWED BY ADDITIONAL CELLS FROM THE RETURN BAG. THE TREATMENT WAS COMPLETED, AND THE CELLS WERE RETURNED TO THE PATIENT POST PHOTOACTIVATION. THE CUSTOMER CALLED BACK TO STATE THAT THE PATIENT HAD GOTTEN UP ABRUPTLY FROM SLEEP TO HAVE A LARGE BOWEL MOVEMENT. THE PATIENT COMPLAINED OF FEELING HOT WHILE IN THE BATHROOM. THE PATIENT RECEIVED AN UNPLANNED TRANSFUSION OF ADDITIONAL VOLUME FROM THE RETURN BAG (BLOOD PRIME UNIT TRANSFUSION) FOR SYMPTOM MANAGEMENT. THE PATIENT RETURNED TO BASELINE WITHIN 5 MINUTES OF ONSET. THE SYSTEM WAS USED FOR TREATMENT OF DISEASE. FROM A UVADEX PERSPECTIVE, THERE IS NO EVIDENCE TO SUGGEST A CAUSAL RELATIONSHIP BETWEEN THE DRUG AND THE ADVERSE EVENT. THIS CASE IS SERIOUS, UNRELATED AND UNEXPECTED TO UVADEX. UVADEX WAS NOT ADMINISTERED WHEN THE ADVERSE EVENT OCCURED. THIS IS NOT REPORTABLE FROM A DRUG PERSPECTIVE. FROM A DEVICE PERSPECTIVE THIS EVENT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY; AND OR THE SYSTEM DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY NOR MALFUNCTIONED 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 WAS RELATED TO THE FLUID SHIFT WHICH IS NORMAL DURING THE ECP PROCEDURE. THE PATIENT'S UNDERLYING CONDITION DID NOT ALLOW THEM TO TOLERATE THE FLUID SHIFT WHICH CAUSED THE CUSTOMER TO PROVIDE INTERVENTION AND GIVE BOTH A SALINE BOLUS AND TRANSFUSION TO THE PATIENT. THEREFORE, THIS 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)

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2015, THE CUSTOMER STATED THAT THE INSTRUMENT SERIAL NUMBER WAS (B)(4). (B)(4). DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    THE CUSTOMER MENTIONED THAT A PATIENT HAD AN ADVERSE EVENT DURING THE BUFFY COAT PHASE OF THE TREATMENT. THE BLOOD PRIME PROCEDURE UTILIZED THE PATIENT'S ECV DURING BUFFY COAT COLLECTION. THE PATIENT STOOD UP TO GO TO THE BATHROOM, AND THE NURSES NOTED PALOR, VOMITING, AND UNSTEADINESS. THE PATIENT WAS BROUGHT BACK TO THE BED AND WAS GIVEN 100ML SALINE BOLUS THROUGH THE INSTRUMENT FOLLOWED BY ADDITIONAL CELLS FROM THE RETURN BAG. THE TREATMENT WAS COMPLETED, AND THE CELLS WERE RETURNED TO THE PATIENT POST PHOTOACTIVATION. ON (B)(6) 2015, THE CUSTOMER CALLED BACK TO STATE THAT THE PATIENT GOT UP ABRUPTLY FROM SLEEP TO HAVE A LARGE BOWEL MOVEMENT. THE PATIENT COMPLAINED OF FEELING HOT WHILE IN THE BATHROOM. THE PATIENT RECEIVED AN UNPLANNED TRANSFUSION OF ADDITIONAL VOLUME FROM THE RETURN BAG (BLOOD PRIME UNIT TRANSFUSION) FOR SYMPTOM MANAGEMENT. THE PATIENT RETURNED TO BASELINE WITHIN FIVE MINUTES OF ONSET. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. NO PRODUCT WAS RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    563762 THERAKOS CELLEX PHOTOPHERESIS SYSTEM CELLEX LNR THERAKOS, INC D326-KIT

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Required Intervention