BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LS LF I.V. EXTENSION

    MDR report key: 1181641 · Received September 30, 2008

    Report

    Report Number
    9615050-2008-00287
    Event Type
    Malfunction
    Date Received
    September 30, 2008
    Date of Event
    August 1, 2008
    Report Date
    September 4, 2008
    Manufacturer
    HOSPIRA DE COSTA RICA LTD.
    Product Code
    FPA
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACT INDICATED THE DEVICE WAS DISCARDED. THIS PRODUCT WAS DESIGNED WITH A REMOVABLE CLAVE PORT. INSTRUCTIONS FOR USE STATE, "REMOVE CAPS WHEN REQUIRED AND SECURE CONNECTIONS."

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A DISCONNECTION; SUBSEQUENTLY, BLOOD LOSS WAS NOTED. AN UNSPECIFIED POWER INJECTOR TUBING SET WAS CONNECTED TO THE REMOVABLE CLAVE OF THE EXTENSION TUBING SET AND WAS BEING USED TO DELIVER AN UNSPECIFIED CONTRAST MEDIA. IT WAS REPORTED THAT AT THE END OF THE SCAN WHEN DETACHING THE POWER INJECTOR TUBING SET FROM THE REMOVABLE CLAVE, THE REMOVABLE CLAVE DISCONNECTED FROM THE EXTENSION TUBING SET AND REMAINED CONNECTED TO THE POWER INJECTOR TUBING SET. A BLOOD LOSS OF 30 ML WAS REPORTED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LS LF I.V. EXTENSION ADMINISTRATION SET FPA HOSPIRA DE COSTA RICA LTD. NA 620595H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK UNSPECIFIED POWER INJECTOR TUBING SET