BEUDAMED
    FDA Adverse Event Other Summary report: N

    THERAKOS

    MDR report key: 1410865 · Received June 24, 2009

    Report

    Report Number
    MW5011769
    Event Type
    Other
    Date Received
    June 24, 2009
    Date of Event
    June 16, 2009
    Report Date
    June 24, 2009
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC., A JOHNSON & JOHNSON COMPANY
    Product Code
    LNR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT RECEIVING PHOTOPHERESIS TREATMENT AND TOLERATING THE TREATMENT WELL. THIS RN OBSERVED A FLUID LEAK IN THE PHOTOACTIVATION MODULE DURING THE FINAL COLLECTION OF BUFFY COAT, APPROXIMATELY 1 HOUR AND 50 MINUTES INTO THE TREATMENT. RETURN LINE TO PT CLAMPED, TREATMENT PAUSED AND DOCTOR AND ECP COORDINATOR, WERE IMMEDIATELY NOTIFIED. THE TREATMENT WAS ABORTED, DUE TO POSSIBLE CONTAMINATION FROM A BREAK IN A STERILE SYS. THE PT HAD NO COMPLAINTS. AN ESTIMATED 250ML BLOOD LOSS DISCARDED WITH ABORTED ECP KIT. PT GIVEN 250ML NSS IV OVER 30 MINUTES AS REPLACEMENT FLUID. STAT H+H ORDERED FOR 2 HOURS AFTER EVENT AND TYPE AND SCREEN FOR 2 UNITS PRBC'S SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERAKOS PHOTOPHERESIS LNR ORTHO-CLINICAL DIAGNOSTICS, INC., A JOHNSON & JOHNSON COMPANY

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Other