BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LS MICROBR EXT SET

    MDR report key: 1812500 · Received August 17, 2010

    Report

    Report Number
    9613251-2010-00111
    Event Type
    Malfunction
    Date Received
    August 17, 2010
    Date of Event
    July 1, 2010
    Report Date
    July 22, 2010
    Manufacturer
    HOSPIRA, LTD.
    Product Code
    FPA
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THAT THE DEVICES WERE DISCARDED. A REPRESENTATIVE DEVICE FROM THE SAME LOT IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN REC'D. THE CATALOG NUMBER 11402 HAS A COMMON DEVICE NAME OF 80FPA AND HAS A 510K OF K052722. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE RPTR UPON QUERY BY HOSPIRA PERSONNEL. (B)(4).

    Description of Event or Problem · 1

    GENERAL REPORT REC'D OF AN UNSPECIFIED NUMBER OF UNDOCUMENTED INCIDENTS OF AIR IN THE TUBING SETS. THE TUBING SETS WERE BEING USED TO DELIVER UNSPECIFIED SOLUTIONS. THE T-CONNECTORS ON THE DISTAL ENDS OF THE TUBING SETS WERE CONNECTED TO THE PTS' UNSPECIFIED ACCESS SITES. THE FEMALE ADAPTERS AT THE PROXIMAL ENDS OF THE TUBING SETS WERE CONNECTED TO UNSPECIFIED DEVICES. IT WAS REPORTED THAT AFTER THE UNSPECIFIED DEVICES WERE DISCONNECTED FROM THE FEMALE ADAPTERS, AIR WAS NOTED IN THE TUBING SETS. THE CUSTOMER CONTACT REPORTED "AIR IS GENERATED IN THE EXTENSION TUBING LINES." THE VOLUMES OF AIR WERE NOT SPECIFIED, HOWEVER, THE CUSTOMER CONTACT STATED THE LINES BECOME "FULL OF AIR." NO AIR WAS DELIVERED TO THE PTS. THE TUBING SETS WERE REPLACED AND THE THERAPIES WERE RESUMED. THERE WERE NO REPORTED ADVERSE PT EFFECTS AND NO REPORTED DELAYS IN THERAPIES CRITICAL TO THESE PTS. NO MEDICAL INTERVENTIONS WERE REQUIRED. THE CUSTOMER CONTACT REPORTED THAT THE NURSES NOW CLAMP THE TUBING SETS PRIOR TO DISCONNECTING THE DEVICES FROM THE FEMALE ADAPTERS. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LS MICROBR EXT SET UNK FPA HOSPIRA, LTD. NA 78096NS

    Patients

    Seq Age Sex Outcome Treatment
    1