BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LSLF EXT SET W CLV

    MDR report key: 2926465 · Received January 16, 2013

    Report

    Report Number
    9613251-2013-00011
    Event Type
    Malfunction
    Date Received
    January 16, 2013
    Date of Event
    January 1, 2012
    Report Date
    December 19, 2012
    Manufacturer
    HOSPIRA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K101677
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THE TUBING 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 INFUSION." THIS REPORT REPRESENTS ALL THE INFORMATION 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 BLOOD LOSS WAS NOTED. ON AN UNSPECIFIED DATE, THE CUSTOMER CONTACT REPORTED THAT DURING A CT SCAN, THE TUBING SET WAS BEING USED TO DELIVER 85-90 ML OF OMNIPAQUE 300, AT A RATE OF 2.0 ML/SECOND, WITH A PRESSURE SETTING OF 200 PSI, VIA A POWER INJECTOR. IT WAS REPORTED THAT THE OPTION LOK MALE ADAPTER OF THE EXTENSION SET WAS CONNECTED TO THE PATIENT'S IV ACCESS SITE. THE CUSTOMER CONTACT REPORTED THAT 35-45 SECONDS AFTER THE DELIVERY WAS STARTED, THE TUBING RUPTURED AT THE CENTER OF THE TUBING SET. IT WAS REPORTED THAT AN UNSPECIFIED VOLUME OF CONTRAST MEDIUM LEAKED AND A REPORTED MINIMAL VOLUME OF BLOOD LOSS WAS NOTED. THE TUBING SET WAS REPLACED AND THE PROCEDURE WAS RESUMED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PATIENT. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23848 LSLF EXT SET W CLV 80FPA FPA HOSPIRA LTD. NA 15213NS

    Patients

    Seq Age Sex Outcome Treatment
    1 MFR GE HEALTHCARE| E-Z EM POWER INJECTOR, MFR BRACCO DIAGNOSTICS| OMNIPAQUE 300 CONTRAST MEDIUM