BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM XL PLS MIC/MAC

    MDR report key: 3952744 · Received May 19, 2014

    Report

    Report Number
    9615050-2014-03495
    Event Type
    Malfunction
    Date Received
    May 19, 2014
    Date of Event
    January 1, 2014
    Report Date
    April 23, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K952799
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME THE CUSTOMER WILL NOT BE RETURNING THE DEVICE FOR EVALUATION. IF THE DEVICE IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED. THE DEVICE WAS NOT RETURNED TO HOSPIRA FOR TESTING AND INVESTIGATION; THEREFORE, ATTRIBUTION OF THE ISSUE TO THE DEVICE COULD NOT BE DETERMINED. 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 A SWOLLEN AND OVERHEATED BATTERY. THE DEVICE WAS RETURNED TO THE BIOMEDICAL DEPARTMENT FOR A SWOLLEN AND OVERHEATED BATTERY. NO TRACKING INFORMATION WAS PROVIDED; THEREFORE, SPECIFIC PATIENT INFORMATION, PUMP PROGRAMMING, OR EVENT DETAILS WERE NOT AVAILABLE. THERE WERE NO REPORTS OF ANY ADVERSE PATIENT EVENTS OR DELAYS IN CRITICAL THERAPY. DURING TESTING AT THE USER FACILITY, IT WAS NOTED THAT THE BATTERY WAS SWOLLEN AND OVERHEATED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295828 PLUM XL PLS MIC/MAC 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK