BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERAKOS CELLEX PHOTOPHERESIS SYSTEM

    MDR report key: 3022941 · Received March 20, 2013

    Report

    Report Number
    2523595-2013-00013
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    February 26, 2013
    Report Date
    February 26, 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

    THIS HAS BEEN DETERMINED TO BE A REPORTABLE EVENT BASED ON THE FACT THAT THE MEDICAL PROFESSIONAL AT THE CUSTOMER SITE ADMINISTERED AN UNPLANNED TRANSFUSION TO THE PT AS A DIRECT RESULT OF THIS EVENT. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A DRIVE TUBE LEAK/BREAK THAT OCCURRED DURING A TREATMENT PROCEDURE. ISSUE STARTED ON: (B)(6) 2013. TREATMENT RESTARTED: NO. CUSTOMER CALLED IN TO REPORT A DRIVE TUBE BREAK AT THE UPPER PORTION OF THE DRIVE TUBE. CUSTOMER STATED THAT THE LOWER PORTION WAS STILL IN THE CENTRIFUGE ARM BUT THE UPPER PORTION BROKE AND CAME FREE. THIS OCCURRED AT APPROXIMATELY 1000ML WHOLE BLOOD PROCESSED. CUSTOMER REPORTING BLOOD/BLOOD PRODUCTS ALL OVER THE INSIDE OF THE CENTRIFUGE AS WELL AS THE TOP OF THE PUMP DECK. CUSTOMER ABORTED THE TREATMENT AND NO BLOOD/BLOOD PRODUCTS WERE RETURNED TO THE PT. ASSOCIATED PROCEDURE KIT: KIT TYPE: CLXUSA. KIT LOT NUMBER: A330. THE KIT WAS REQUESTED FROM THE CUSTOMER SITE FOR AN INVESTIGATION. INCIDENT HAD ALREADY OCCURRED WHEN THE CUSTOMER CALLED IN. THERE WERE NO REPORTS OF EXPOSURE TO BIOHAZARDOUS FLUIDS. CUSTOMER STATED THAT THE PT WAS STABLE. THE PT WAS GIVEN ONE UNIT OF PACKED RED BLOOD CELLS AND 6 UNITS OF PLATELETS (PLATELET COUNT WAS 20 PRE TREATMENT) AS AN OUT PT PROCEDURE. THE CUSTOMER ADDED THAT THE INSTRUMENT WAS SET IN DOUBLE NEEDLE MODE DURING THE TREATMENT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116210 THERAKOS CELLEX PHOTOPHERESIS SYSTEM CELLEX ECP SYSTEM LNR THERAKOS 6661 A330

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention