BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOME KIT, CT-SET

    MDR report key: 880311 · Received September 11, 2006

    Report

    Report Number
    9616662-2006-00010
    Event Type
    Malfunction
    Date Received
    September 11, 2006
    Date of Event
    August 10, 2006
    Report Date
    August 12, 2006
    Manufacturer
    MERIT MEDICAL IRELAND, LTD.
    Product Code
    FPA
    PMA / PMN Number
    exempt
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICE INVOLVED IN THE REPORTED INCIDENT WAS RETURNED TO CO FOR EVALUATION. BLOOD WAS FOUND THROUGH THE FLUID PATH OF THE DEVICE, CONFIRMING THE COMPLAINANT'S REPORT. A SERIES OF INJECTIONS AND ASPIRATIONS WAS PERFORMED ON THE SUSPECT DEVICE. THERE WAS NO BACK FLOW OF FLUID THROUGH THE VALVE AT ANY POINT DURING THE TESTING. THE ALLEGED FAILURE COULD NOT BE DUPLICATED. VALVES OF THIS TYPE ARE NOT INTENDED FOR USE AT HIGH PRESSURES. CO HAS FOUND THAT, WHEN EXPOSED TO HIGH PRESSURES, THE TYPE OF FAILURE REPORTED CAN OCCUR.

    Description of Event or Problem · 1

    FOLLOWING CT CONTRAST INJECTION PROCEDURE, THE K08-01084 WAS DISCONNECTED FROM THE CT TRANSFER LINE. THE K08-01084 REMAINED ATTACHED TO THE VENOUS CANNULA INSERTED IN THE PATIENT. FOLLOWING THE DISCONNECTION OF THE K08-01084 FROM THE CT TRANSFERT LINE, BLOOD FLOWED BACK THROUGH THE ONE WAY VALVES OF THE PATIENT LINE AND ONTO THE FLOOR. THE PATIENT WAS NOT SPRAYED WITH THE LEAKING FLUID; A CLINICIAN WAS SPRAYED ON THE FEET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUSTOME KIT, CT-SET FLUID ADMINISTRATION SYSTEM FPA MERIT MEDICAL IRELAND, LTD. NA C353322

    Patients

    Seq Age Sex Outcome Treatment
    1 YR PUMP INJECTOR| VENOUS CANNULA (NOT MERIT)| CT TRANSFER LINE (KO8-00801)