BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM A+ DRIVER NEW

    MDR report key: 3970811 · Received April 29, 2014

    Report

    Report Number
    9615050-2014-03093
    Event Type
    Malfunction
    Date Received
    April 29, 2014
    Date of Event
    January 1, 2014
    Report Date
    April 1, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K042081
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THAT THE DEVICE OVERHEATED AND POWERED OFF BY ITSELF. THE CUSTOMER CONTACT STATED IT IS UNK IF THE DEVICE SOUNDED AN AUDIBLE ALARM PRIOR TO POWERING OFF. THE DEVICE WAS RETURNED TO THE BIOMEDICAL DEPT WITH A NOTE THAT STATED, "IV PUMP OVERHEATING AND TURNS ITSELF OFF." NO TRACKING INFO WAS PROVIDED; THEREFORE, SPECIFIC PT INFO, PUMP PROGRAMMING, OR EVENT DETAILS WERE NOT AVAILABLE. THERE WERE NO REPORTS OF ANY ADVERSE PT EVENTS OR DELAYS IN CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255779 PLUM A+ DRIVER NEW 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK PLUM A+ SOFTWARE MODULE, LIST#20791, SN (B)(4)