BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM XLMD PUMP

    MDR report key: 1030940 · Received April 17, 2008

    Report

    Report Number
    2921482-2008-00125
    Event Type
    Malfunction
    Date Received
    April 17, 2008
    Date of Event
    March 17, 2008
    Report Date
    March 28, 2008
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    PMA / PMN Number
    K010924
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING AND INVESTIGATION FOUND THE DEVICE DID NOT SOUND AN AUDIBLE ALARM TONE WHILE ON THE LOW VOLUME SETTING. THIS WAS DUE TO A SHORT IN THE PIEZO BUZZER DUE TO DETERIORATION OF THE BUZZER'S SILVER COATING THAT CREATED A SILVER BRIDGE BETWEEN TWO PINS. THE SILVER BRIDGE WAS CAUSED BY CONTAMINATION.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THAT THE DEVICE DID NOT SOUND AN AUDIBLE ALARM TONE DURING AN ALARM CONDITION WHILE ON THE LOW OR HIGH VOLUME SETTINGS. THE PUMP WAS RETURNED TO THE BIOMEDICAL ENGINEERING DEPARTMENT WITHOUT ANY INFO. NO TRACKING INFO WAS PROVIDED; THEREFORE, SPECIFIC PT INFO, PUMP PROGRAMMING, OR EVENT DETAILS WERE NOT AVAILABLE. DURING TESTING, THE DEVICE DID NOT SOUND AN AUDIBLE ALARM TONE DURING AN ALARM CONDITION WHILE ON THE LOW OR HIGH VOLUME SETTINGS. THERE WERE NO REPORTS OF ANY ADVERSE PT EVENTS WHILE THE DEVICE WAS IN CLINICAL USE. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK