BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERAKOS CELLEX SYSTEM

    MDR report key: 3834483 · Received May 2, 2014

    Report

    Report Number
    2523595-2014-00136
    Event Type
    Injury
    Date Received
    May 2, 2014
    Date of Event
    April 3, 2014
    Report Date
    April 3, 2014
    Manufacturer
    THERAKOS INC.
    Product Code
    LNR
    PMA / PMN Number
    P680003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH RECORD REVIEW OF LOT C302 WAS CONDUCTED. THERE WERE NO NON CONFORMANCES ASSOCIATED WITH THIS LOT. LOT MET RELEASE REQUIREMENTS. THIS ASSESSMENT IS BASED ON INFORMATION AVAILABLE AT THE TIME OF THE INVESTIGATION. THE INSTRUMENT PERFORMED AS INTENDED. HOWEVER, THERAKOS HAS ELECTED TO REPORT THIS EVENT DUE TO THE PATIENT BEING GIVEN INCREASED O2 AND THE HOSPITALIZATION. COMPLAINTS ARE MONITORED THROUGH TRACKING AND TRENDING. IF ADDITIONAL INFORMATION IS RECEIVED, THE COMPLAINT WILL BE REOPENED AND PROCESSED ACCORDINGLY.

    Description of Event or Problem · 1

    THERAKOS CLINICAL EDUCATOR REPORTED, ON BEHALF OF THE CUSTOMER, A PATIENT REACTION AFTER A TREATMENT PROCEDURE. A (B)(6) MALE, EXPERIENCED RESPIRATORY DISTRESS FOLLOWING TREATMENT. PATIENT ATTEMPTED TO GO TO THE BATHROOM AND GET DRESSED AND WAS NOT ABLE TO ACCOMPLISH THESE TASKS. HE RETURNED TO BED, O2 WAS INCREASED FROM 3L TO 5L. PHYSICIAN SUSPECTED FLUID OVERLOAD AND ADMITTED PATIENT FOR OVERNIGHT OBSERVATION. PERFORMED BLOOD GAS, CHEST X-RAY. THE CUSTOMER REPORTED THE CHEST X-RAY WAS CLEAR AND BLOOD GASES UNREMARKABLE. THE PATIENT DID FINE OVERNIGHT, AND WAS SCHEDULED FOR AN ECP TREATMENT THE NEXT DAY. THE THERAKOS CLINICAL SERVICE SPECIALIST CALLED THE CUSTOMER BACK ON (B)(6) 2014 TO INQUIRE ABOUT THE PATIENTS CONDITION AND THE OUTCOME OF THE SCHEDULED ECP TREATMENT. THE CUSTOMER STATED THE TREATMENT PROCEDURE WAS UNEVENTFUL AND REPORTED THAT THE PATIENT WAS DOING FINE AFTER THE PROCEDURE. ON THE MEDICAL ASSESSMENT FORM THAT WAS COMPLETED BY THE CUSTOMER AND RETURNED TO THERAKOS, THE NURSE STATED THAT SHE FELT THE PATIENT'S UNDERLYING CONDITION, NOT THE TREATMENT, WAS THE CAUSE OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264065 THERAKOS CELLEX SYSTEM CELLEX LNR THERAKOS INC. C302-KIT

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Hospitalization| R