BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LSLF EXT SET W CLV

    MDR report key: 2152489 · Received June 27, 2011

    Report

    Report Number
    9613251-2011-00142
    Event Type
    Malfunction
    Date Received
    June 27, 2011
    Date of Event
    May 1, 2011
    Report Date
    June 10, 2011
    Manufacturer
    HOSPIRA LTD.
    Product Code
    FPK
    PMA / PMN Number
    K941214
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THE DEVICE WAS DISCARDED. 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 IV ADMINISTRATION SETS ARE INTENDED FOR GENERAL INFUSION AND NOT RECOMMENDED FOR USE WITH POWER INJECTORS. PRODUCT LABELING FOR THIS DEVICE STATES, "CAUTION: NOT FOR HIGH PRESSURE INFO." THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    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 100ML OF OMNIPAQUE CONTRAST MEDIA, AT A RATE OF 1.5ML/SEC, VIA A POWER INJECTOR. IT WAS REPORTED THAT AFTER THE DELIVERY WAS STARTED, THE TUBING RUPTURED AT AN UNSPECIFIED LOCATION IN THE TUBING. AN UNSPECIFIED VOLUME OF BLEED BACK WAS NOTED. THE TUBING SET WAS REPLACED AND THE PROCEDURE WAS RESUMED. THERE WERE NO REPORTED ADVERSE PT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PT. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LSLF EXT SET W CLV 80FPK FPK HOSPIRA LTD. NA UNKNS

    Patients

    Seq Age Sex Outcome Treatment
    1 UNSPECIFIED POWER INJECTOR, MFR UNK