BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM A+ PUMP

    MDR report key: 1231138 · Received October 30, 2008

    Report

    Report Number
    2921482-2008-00343
    Event Type
    Malfunction
    Date Received
    October 30, 2008
    Date of Event
    September 24, 2008
    Report Date
    October 7, 2008
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    PMA / PMN Number
    K052052
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME THE CUSTOMER WILL NOT BE RETUNING THE DEVICE FOR EVALUATION. IF THE DEVICE IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THE DEVICE DISPLAYED SETTINGS THAT WERE DIFFERENT THAN THE ORIGINALLY PROGRAMMED SETTINGS. THE DEVICE WAS RETURNED TO THE BIOMEDICAL ENGINEERING DEPARTMENT WITH A NOTE THAT STATED, "IN 2008, IV PUMP MALFUNCTIONING, IE, 4 ML RATE WITH DURATION 12 HRS, PUMP CHANGES VOLUME TO 0.1 ML AND DURATION TO 27 MIN." NO TRACKING INFORMATION WAS PROVIDED; THEREFORE, SPECIFIC PATIENT INFORMATION, PUMP PROGRAMMING, OR EVENT DETAILS WERE NOT AVAILABLE. THERE WERE NO REPORTS OF ANY ADVERSE PT 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 PLUM A+ PUMP 80-FRN FRN HOSPIRA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK PLUM A+ SOFTWARE MODULE