BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERAKOS CELLEX PHOTOPHERESIS SYSTEM

    MDR report key: 3941943 · Received June 9, 2014

    Report

    Report Number
    2523595-2014-00161
    Event Type
    Malfunction
    Date Received
    June 9, 2014
    Date of Event
    May 16, 2014
    Report Date
    May 16, 2014
    Manufacturer
    THERAKOS, INC.
    Product Code
    LNR
    PMA / PMN Number
    P680003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH RECORD REVIEW OF LOT C111 WAS CONDUCTED. THERE WERE NO NON CONFORMANCES RELATED TO THIS LOT. LOT MET RELEASE REQUIREMENTS. TRENDS HAVE BEEN REVIEWED FOR THIS COMPLAINT CATEGORY AND NO TREND HAS BEEN DETECTED; HOWEVER, CAPA'S (B)(4) ARE ALREADY IN PROGRESS TO INVESTIGATE PRESSURE DOME MEMBRANE LEAKS. SERVICE ORDER (B)(4) COMPLETED: SERVICE ENGINEER REPLACED THE RETURN PRESSURE SENSOR AND PERFORMED CHECK OUT PROCEDURE. THE ASSESSMENT IS BASED ON INFORMATION AVAILABLE AT THE TIME OF THE INVESTIGATION. NO PRODUCT HAS BEEN RETURNED FOR INVESTIGATION AND THE PHOTO EVALUATION IS STILL IN PROGRESS AT THE TIME OF THIS REPORT; THEREFORE, FINAL INVESTIGATION FINDINGS ARE STILL PENDING. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED A BLOOD LEAK AT THE RETURN PRESSURE SENSOR. ISSUE OCCURRED WHILE BUFFY COAT WAS PHOTOACTIVATING AND RBC WERE RETURNING TO PATIENT AT 50 ML/MIN. BECAUSE OF A POOR VEIN FOR RETURN, NURSE HAD LEFT THE COLLECT LINE CONNECTED TO PATIENT (IV CATHETER). DURING THE RBC RETURN, A COLLET PRESSURE ALARM OCCURRED, SO NURSE RINSED THE COLLECT LINE WITH A SYRINGE FILLED WITH SALINE. WHEN NURSE PUSHED THE SALINE INTO THE CATHETER, THE RETURN PRESSURE DOME POPPED UP. THE NURSE THEN ABORTED THE TREATMENT. WHOLE BLOOD PROCESSED 1510 ML. VOLUME OF RBC IN THE RETURN BAG: 240 ML, NOT RETURNED TO PATIENT. TREATMENT VOLUME IN THE TREATMENT BAG: 168ML, NOT RETURNED TO PATIENT. PATIENT'S PULSE AFTER EVENT: 109 BPM. NURSE INFORMED SHE WAS A SMALL CLOT TO THE NEEDLE OF THE CATHETER WHEN SHE MOVED IT AS KIT WAS BEING DISCARDED. PATIENT CONDITION: STABLE. NO PRODUCT WAS RETURNED FOR INVESTIGATION, BUT PHOTOS PROVIDED Y CUSTOMER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333975 THERAKOS CELLEX PHOTOPHERESIS SYSTEM CELLEX LNR THERAKOS, INC. C111-KIT

    Patients

    Seq Age Sex Outcome Treatment
    1