BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED SYMBIQ PUMP

    MDR report key: 1170788 · Received September 15, 2008

    Report

    Report Number
    2921482-2008-00289
    Event Type
    Malfunction
    Date Received
    September 15, 2008
    Date of Event
    August 1, 2008
    Report Date
    August 22, 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 THE PATIENT RECEIVED LESS MEDICATION THAN INTENDED. ON AN UNSPECIFIED DATE, THE DEVICE WAS PROGRAMMED FOR PIGGYBACK DELIVERY OF AN UNSPECIFIED MEDICATION AND THE DELIVERY WAS STARTED. NO SPECIFIC PROGRAMMING PARAMETERS WERE PROVIDED. AFTER AN UNSPECIFIED LENGTH OF TIME, THE NURSE NOTED THE DEVICE DISPLAY INDICATED A 20ML VOLUME TO BE INFUSED; HOWEVER, 100ML OF THE MEDICATION STILL REMAINED IN THE SOLUTION CONTAINER. THERE WERE 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