BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAF IV EXT CL OL

    MDR report key: 1180846 · Received September 23, 2008

    Report

    Report Number
    9615050-2008-00281
    Event Type
    Malfunction
    Date Received
    September 23, 2008
    Date of Event
    July 1, 2008
    Report Date
    August 29, 2008
    Manufacturer
    HOSPIRA DE COSTA RICA LTD.
    Product Code
    FPK
    PMA / PMN Number
    PREAMD
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED SINCE THIS IS A KNOWN ISSUE. THE ISSUE OF SPLIT OR BURST TUBING WHEN USING POWER INJECTORS WAS EVALUATED UNDER A FORMAL INVESTIGATION. IT WAS DETERMINED THAT THIS IS NOT A MANUFACTURING OR MATERIALS DEFECT. IT WAS COMMUNICATED TO THE CUSTOMER THAT STANDARD I.V. ADMINISTRATION SETS ARE INTENDED FOR GENERAL INFUSION AND NOT RECOMMENDED FOR USE WITH POWER INJECTORS. IN ADDITION, THE INFUSION THERAPY ACCOUNT MANAGERS WERE ADVISED OF THIS ISSUE AND WERE PROVIDED WITH A PRODUCT LIST OF THOSE HIGH-PRESSURE SETS THAT ARE APPROPRIATE FOR USE WITH POWER INJECTORS.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A TUBING RUPTURE WHILE IN USE WITH A POWER INJECTOR; SUBSEQUENTLY BLEED BACK WAS NOTED. THE TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED CONTRAST USING A POWER INJECTOR AT AN UNSPECIFIED RATE. AFTER AN UNSPECIFIED LENGTH OF TIME IN USE, THE TUBING RUPTURED AT AN UNSPECIFIED LOCATION. THE CUSTOMER CONTACT REPORTED AN UNSPECIFIED VOLUME OF BLOOD BACKED UP INTO THE TUBING. THE TUBING SET WAS REPLACED AND THE PROCEDURE WAS COMPLETED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DAF IV EXT CL OL 80-FPK FPK HOSPIRA DE COSTA RICA LTD. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 ADULT UNSPECIFIED CONTRAST MEDIA| UNSPECIFIED POWER INJECTOR