BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED SYMBIQ PUMP

    MDR report key: 1151007 · Received August 28, 2008

    Report

    Report Number
    2921482-2008-00265
    Event Type
    Malfunction
    Date Received
    August 28, 2008
    Date of Event
    July 1, 2008
    Report Date
    August 4, 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.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED AIR IN THE TUBING DISTAL TO THE PUMP WITH NO PUMP ALARM. ON AN UNSPECIFIED TIME AND DATE, THE PUMP WAS PROGRAMMED TO DELIVER AN UNSPECIFIED MEDICATION AND THE DELIVERY WAS STARTED. NO SPECIFIC PUMP PROGRAMMING PARAMETERS WERE PROVIDED. AFTER AN UNSPECIFIED LENGTH OF TIME, THE NURSE NOTED "AIR IN LINE THAT PROCEEDS PAST THE CASSETTE WITH NO ALARMS IN AN ARTERIAL LINE." AT THIS TIME, THE NURSE STOPPED THE DELIVERY. THE TUBING SET WAS DISCONNECTED FROM THE PATIENT, THE AIR WAS REMOVED AND THERAPY WAS RESUMED. NO AIR WAS DELIVERED TO THE PATIENT. THERE WAS NO REPORTED ADVERSE PATIENT EFFECTS. NO MEDICAL INTERVENTIONS WERE REQUIRED. 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