BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LSLF EXT SET W CLV

    MDR report key: 3894360 · Received April 23, 2014

    Report

    Report Number
    9613251-2014-00093
    Event Type
    Malfunction
    Date Received
    April 23, 2014
    Date of Event
    March 1, 2014
    Report Date
    April 4, 2014
    Manufacturer
    HOSPIRA, LTD
    Product Code
    FPA
    PMA / PMN Number
    K101677
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE OPENED SAMPLE WAS EVALUATED. THE DEVICE PASSED TESTING. KINKS IN THE TUBING WERE NOTED DURING THE TESTING PROCEDURES AND SOLUTION FLOWED THE DEVICE. BASED ON THE DATA VERIFIED, HOSPIRA COULD NOT ATTRIBUTE THE ISSUE TO THE DEVICE. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    GENERAL REPORT RECEIVED OF AN UNSPECIFIED NUMBER OF UNDOCUMENTED INCIDENTS OF NO FLOW. ON UNSPECIFIED DATES, THE EXTENSION TUBING SETS WERE CONNECTED TO PTS' IV ACCESS SITES AND WERE BEING USED FOR INTERMITTENT DELIVERIES OF UNSPECIFIED MEDICATIONS. THE CUSTOMER CONTACT REPORTED THAT AFTER THE EXTENSION TUBING SETS WERE TAPED IN A J-LOOP POSITION FOR STABILIZATION, THE TUBING KINKED AT UNSPECIFIED LOCATIONS AND IMPEDED THE FLOW OF SOLUTIONS. THERE WERE NO REPORTS OF ADVERSE PT EFFECTS AND NO REPORTED DELAYS IN THERAPIES CRITICAL FOR THESE PTS. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED INCLUDING IF THE TUBING SETS WERE REPLACED AND THE THERAPIES WERE RESUMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245307 LSLF EXT SET W CLV 80FPA FPA HOSPIRA, LTD NA UNK4W

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK