BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM XLMD PUMP

    MDR report key: 1083240 · Received July 24, 2008

    Report

    Report Number
    2921482-2008-00228
    Event Type
    Malfunction
    Date Received
    July 24, 2008
    Date of Event
    May 3, 2008
    Report Date
    June 26, 2008
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    PMA / PMN Number
    K010924
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. 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 DEVICE DID NOT SOUND AN AUDIBLE ALARM DURING AN ALARM CONDITION WHILE ON THE LOW VOLUME SETTING. THE PUMP WAS RETURNED TO THE BIOMEDICAL ENGINEERING DEPARTMENT WITH A NOTE THAT STATED, "SOUND DOES NOT WORK ON LOW." NO TRACKING INFO WAS PROVIDED; THEREFORE, SPECIFIC PATIENT INFO, PUMP PROGRAMMING, OR EVENT DETAILS WERE NOT AVAILABLE. DURING TESTING AT THE USER FACILITY, THE DEVICE DID NOT SOUND AN AUDIBLE ALARM TONE DURING AN ALARM CONDITION WHILE ON THE LOW VOLUME SETTING. THERE WERE NO REPORTS OF ANY ADVERSE PATIENT 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