BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LSLF EXT SET W CLV

    MDR report key: 2180672 · Received May 5, 2011

    Report

    Report Number
    9613251-2011-00078
    Event Type
    Malfunction
    Date Received
    May 5, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 19, 2011
    Manufacturer
    HOSPIRA, LTD
    Product Code
    FPK
    PMA / PMN Number
    K941214
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A KNOWN ISSUE AND NO EVAL WILL BE PERFORMED ON THE CUSTOMER'S DEVICE. 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 MFG 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. PRODUCT LABELING FOR THIS DEVICE STATES, "CAUTION: NOT FOR HIGH PRESSURE INFUSION." THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE RPTR UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    GENERAL REPORT REC'D OF AN UNSPECIFIED NUMBER OF UNDOCUMENTED INCIDENTS OF TUBING RUPTURES WHILE IN USE WITH POWER INJECTORS; SUBSEQUENTLY BLOOD LOSS WAS NOTED. DURING CT SCANS, THE TUBING SETS WERE BEING USED TO DELIVER UNSPECIFIED VOLUMES OF OMNIPAQUE 300 CONTRAST MEDIUM AT A RATE OF 3ML/SEC VIA A MEDRAD POWER INJECTOR. IT WAS REPORTED THAT IMMEDIATELY AFTER THE DELIVERIES STARTED, THE TUBINGS RUPTURED AT UNSPECIFIED LOCATIONS. UNSPECIFIED VOLUMES OF BLOOD WERE LOST. THE TUBINGS WERE CLAMPED USING THE SLIDE CLAMPS. THE TUBING SETS WERE REPLACED AND THE PROCEDURES WERE RESUMED. THERE WERE NO REPORTED ADVERSE PT EFFECTS AND NO REPORTED DELAYS OF THERAPY CRITICAL TO THESE PTS. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADD'L 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, MANUFACTURED BY| MEDRAD, INC.| OMNIPAQUE 300, MANUFACTURED BY GE HEALTHCARE, INC.