BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NI

    MDR report key: 730869 · Received June 22, 2006

    Report

    Report Number
    1221261-2006-00015
    Event Type
    Malfunction
    Date Received
    June 22, 2006
    Report Date
    May 24, 2006
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    DTR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    H.6. EVAL - OTHER: SMITHS MEDICAL ASD, INC. HAS MADE MANY ATTEMPTS TO CONTACT THE HOSP TO DETERMINE WHAT DISPOSABLE WAS USED WHEN THIS EVENT OCCURRED WITHOUT SUCCESS. SMITHS MEDICAL ASD, INC. IS UNABLE TO PERFORM A THOROUGH INVESTIGATION WITHOUT THE RETURN OF THE ACTUAL SAMPLE INVOLVED. IF THE DISPOSABLE UNIT IS RETURNED AN INVESTIGATION WILL BE PERFORMED OR IF INFO IS RECEIVED OTHER THAN WHAT IS REPORTED; THEN A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    USER ALLEGES THAT THE HEAT EXCHANGER RUPTURED, RESULTING IN BLOOD TO BE OBSERVED IN THE WATER RESERVOIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NI NI DTR SMITHS MEDICAL ASD, INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO