BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED SYMBIQ PUMP

    MDR report key: 1170266 · Received September 11, 2008

    Report

    Report Number
    2921482-2008-00282
    Event Type
    Malfunction
    Date Received
    September 11, 2008
    Date of Event
    January 1, 2008
    Report Date
    August 15, 2008
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    PMA / PMN Number
    K041550
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT ISOLATED OR IDENTIFIED BY SERIAL NUMBER; THEREFORE, IT WILL NOT BE RETURNED FOR INVESTIGATION. THE LIST FOR THE DEVICE IN USE IS UNKNOWN. THE CUSTOMER IDENTIFIED TWO POSSIBLE LIST NUMBERS 16026 AND 16027. 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 AIR WAS NOTED IN THE TUBING DISTAL TO THE PUMP WITH NO PUMP ALARM. IT WAS REPORTED THAT AFTER AN UNSPECIFIED LENGTH OF TIME IN USE, A NURSE NOTED "LARGE CHUNKS OF AIR APPEAR TO PASS CASSETTE." NO TRACKING INFORMATION WAS PROVIDED; THEREFORE, SPECIFIC PATIENT INFORMATION, PUMP PROGRAMMING, OR EVENT DETAILS WERE NOT AVAILABLE. THERE WERE NO REPORTS OF ANY ADVERSE PATIENT EVENTS WHILE THE DEVICE WAS IN CLINICAL USE. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNSPECIFIED SYMBIQ PUMP 80-FRN FRN HOSPIRA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK