BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CELLEX PHOTOPHERESIS SYSTEM

    MDR report key: 6211569 · Received December 28, 2016

    Report

    Report Number
    2523595-2016-00285
    Event Type
    Injury
    Date Received
    December 28, 2016
    Date of Event
    November 30, 2016
    Report Date
    December 28, 2016
    Manufacturer
    THERAKOS, INC
    Product Code
    LNR
    UDI-DI
    10705030100009
    PMA / PMN Number
    P860003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM WAS USED FOR TREATMENT. A BATCH RECORD REVIEW OF KIT LOT E218 WAS CONDUCTED. THERE WERE NO NONCONFORMANCES ASSOCIATED WITH THIS LOT. THE LOT MET RELEASE REQUIREMENTS. TRENDS WERE REVIEWED FOR COMPLAINT CATEGORIES, ALARM #17: RETURN PRESSURE AND CLOT OBSERVED. NO TRENDS WERE DETECTED FOR THESE COMPLAINT CATEGORIES. 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. (B)(4). DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED MULTIPLE ALARM #17: RETURN PRESSURE ALARMS AFTER 339 ML OF WHOLE BLOOD PROCESSED. THE CUSTOMER STATED THAT THEY DECREASED THE RETURN RATE, BUT THE ALARM CONTINUED TO OCCUR. THE CUSTOMER REPORTED THAT THEY FLUSHED THE PATIENT'S ACCESS USING A 10 ML SALINE SYRINGE, HOWEVER THE ALARM CONTINUED TO OCCUR. THE CUSTOMER STATED THAT THEY THEN REDUCED THE RETURN RATE TO 15 ML/MIN AND INCREASED THE PRESSURE ALLOWANCE IN THE INSTRUMENT'S SETUP, BUT THE ALARM CONTINUED TO OCCUR. THE CUSTOMER REPORTED THAT THEY COULD SEE CLOTS IN THE RETURN BAG. THE CUSTOMER STATED THAT 15 000 IE HEPARIN IN 500 ML SALINE WAS THE ANTICOAGULANT RATIO THAT WAS USED FOR THIS TREATMENT. THE CUSTOMER REPORTED THAT THE TREATMENT WAS ABORTED WITH NO RETURN OF BLOOD/PRODUCTS TO THE PATIENT. THE CUSTOMER STATED THAT THE APPROXIMATE BLOOD LOSS WAS 338 ML. THE CUSTOMER REPORTED THAT THE PATIENT RECEIVED 500 ML OF SALINE AFTER THE TREATMENT AND A BLOOD TRANSFUSION WAS PLANNED. ON (B)(6) 2016, THE CUSTOMER CONFIRMED THAT THE PATIENT DID RECEIVE AN UNPLANNED TRANSFUSION OF TWO UNITS OF RED BLOOD CELLS. THE CUSTOMER STATED THAT THE PATIENT HAD RECEIVED A TREATMENT THE FOLLOWING DAY, AND THAT THE TREATMENT WAS COMPLETED WITHOUT ANY ISSUES. THE CUSTOMER REPORTED THAT THE PATIENT WAS IN STABLE CONDITION. THE INSTRUMENT WAS NOT RETURNED FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    861002 CELLEX PHOTOPHERESIS SYSTEM CELLEX PHOTOPHERESIS SYSTEM LNR THERAKOS, INC NOT APPLICABLE NOT APPLICABLE 10705030100009

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention