BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERAKOS CELLEX PHOTOPHERESIS SYSTEM

    MDR report key: 2961222 · Received February 8, 2013

    Report

    Report Number
    2523595-2013-00006
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Date of Event
    January 30, 2013
    Report Date
    January 30, 2013
    Manufacturer
    THERAKOS
    Product Code
    LNR
    PMA / PMN Number
    P680003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ROOT CAUSE WAS CONFIRMED BY VISUAL INSPECTION BY THE CUSTOMER TO BE A LEAK IN THE TUBING BOND JOINT OF THE PRESSURE DOME. THIS EVENT IS REPORTABLE. THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY; BUT IT MALFUNCTIONED IN A WAY THAT WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, IF THE MALFUNCTION WERE TO RECURE DUE TO THE FACT THAT THIS SHARES THE SAME ROOT CAUSE AS A PREVIOUSLY REPORTED MALFUNCTION. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CALLED TO REPORT A BLOOD LEAK ALARM THAT OCCURRED DURING A TREATMENT PROCEDURE. ISSUE STARTED ON: (B)(6) 2013. THE CUSTOMER CALLED TO REPORT BLOOD LEAKING FORM THE KIT. CUSTOMER STATED SHE OBSERVED BLOOD LEAKING FROM THE BOND JOINT OF THE COLLECT PRESSURE DOME TO THE TUBING OF THE KIT. CUSTOMER ABORTED THE TREATMENT AND DID NOT RETURN ANY BLOOD OR PRODUCTS TO PATIENT. A NEW TREATMENT WAS NOT RESTARTED. ASSOCIATE PROCEDURAL KIT: KIT TYPE: CLXUSA KIT LOT NUMBER: A328-635. CTS ASKED THE CUSTOMER TO RETURN THE KIT TO THERAKOS FOR AN INVESTIGATION AND THE CUSTOMER AGREED TO DO SO. CTS ASKED IF THERE WERE ANY ERROR DURING PRIME. CUSTOMER STATED THERE WERE NO ALARMS DURING PRIME. DRA (B)(4) HAS BEEN OPENED TO REVIEW THE CELLEX KIT THAT HAS BEEN REQUESTED FROM THE CUSTOMER SITE. TO DATE, THE KIT HAS NOT BEEN RECEIVED FROM THE CUSTOMER SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53921 THERAKOS CELLEX PHOTOPHERESIS SYSTEM CELLEX ECP SYSTEM LNR THERAKOS 6661 A328

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR