BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERAKOS CELLEX PHOTOPHERESIS SYSTEM

    MDR report key: 2960818 · Received February 11, 2013

    Report

    Report Number
    2523595-2013-00007
    Event Type
    Injury
    Date Received
    February 11, 2013
    Date of Event
    January 15, 2013
    Report Date
    January 15, 2013
    Manufacturer
    THERAKOS
    Product Code
    LNR
    PMA / PMN Number
    P680003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (BATCH RECORD REVIEW) KIT LOT A324 MET ALL RELEASE REQUIREMENTS AND SHOWS NO NONCONFORMANCES. (KIT RETURN) INVESTIGATION STILL PENDING, THE KIT HAS NOT BEEN RECEIVED TO DATE FROM THE CUSTOMER SITE. THERAKOS MEDICAL ASSESSMENT WAS COMPLETE (B)(4) 2013 TO STATE THE FOLLOWING: PATIENT RECEIVED A TRANSFUSION BECAUSE HIS HAEMOGLOBIN LEVEL WAS ALREADY LOW BEFORE THE TREATMENT AND THE LOST OF 450 ML DROVE THE MEDICAL PROFESSIONAL'S DECISION TO TAKE PREVENTIVE ACTION. DUE TO THE FACT THAT THERE WAS AN UNPLANNED TRANSFUSION, THIS INCIDENT IS REPORTABLE BASED ON THERAKOS PROCEDURES. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY OBSERVED THAT THE DRIVE TUBE BROKE DURING A TREATMENT PROCEDURE AT ABOUT 450 ML WHOLE BLOOD PROCESSED. THE DRIVE TUBE BROKEN NEXT TO THE UPPER BEARING. THE TREATMENT WAS ABORTED AND NO BLOOD WAS RETURNED TO THE PATIENT. THE PATIENT WAS GIVEN AN UNPLANNED TRANSFUSION (1 UNIT) DUE TO THE LOSS OF THE BLOOD THAT WAS NOT RETURNED AFTER THE TREATMENT WAS ABORTED. NAME AND FUNCTION OF COMPLAINANT/REPORTER: (B)(6), NURSE. ISSUE STARTED ON: (B)(6) 2013. CUSTOMER STATED THE SINGLE NEEDLE MODE TREATMENT WAS ABORTED AND NO BLOOD IN THE KIT AT THAT TIME WAS RETURNED TO THE PATIENT. CUSTOMER STATED THE PATIENT HAD TO STAY LATER IN THE HOSPITAL IN ORDER TO BE GIVEN ONE UNIT OF BLOOD AFTER THE DRIVE TUBE BROKE. CUSTOMER STATED THE UPPER BEARING WAS INSTALLED CORRECTLY, AND WAS STILL HELD IN THE UPPER RETAINER WITH THE RETAINER CLIP CLOSED AFTER THE DRIVE TUBE BROKE. CUSTOMER STATED THAT THERE WAS NO UNUSUAL NOISES OR ALARMS BEFORE THE DRIVE TUBE BROKE. THERE WAS NO UVADEX ADMINISTERED TO THE PATIENT DURING TREATMENT. CUSTOMER STATED SHE HAD ALREADY CLEANED THE CENTRIFUGE CAREFULLY WITH HYDROGEN PEROXIDE, AND SHE DID NOT SEE ANY DAMAGE TO THE CENTRIFUGE LEAK SENSOR STRIP. CUSTOMER STATED SHE HAD THEN POWERED THE INSTRUMENT ON, AND NO ALARMS OR ERRORS OCCURRED. CUSTOMER REQUESTED FIELD SERVICE BE DISPATCHED TO CHECK THE INSTRUMENT BEFORE THEY USE IT AGAIN. FE DISPATCHED UNDER A SEPARATE COMPLAINT. THE CUSTOMER WILL RETURN THE SMART CARD FOR AN INVESTIGATION. AN OCD FIELD ENGINEER RESPONDED TO THE SITE TO REPAIR THE INSTRUMENT. FE REPAIRED SERIAL (B)(4). PARTS WERE IDENTIFIED THAT NEEDED TO BE REPLACED. REPAIRS HAVE RETURNED THIS INSTRUMENT TO EXPECTED OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59387 THERAKOS CELLEX PHOTOPHERESIS SYSTEM CELLEX ECP SYSTEM LNR THERAKOS 6661 A324

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention