BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM XL PLS MIC/MAC

    MDR report key: 3832808 · Received March 17, 2014

    Report

    Report Number
    9615050-2014-02004
    Event Type
    Malfunction
    Date Received
    March 17, 2014
    Date of Event
    February 10, 2014
    Report Date
    February 17, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K952799
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. 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 BURNING SMELL. THE DEVICE WAS RETURNED TO THE BIOMEDICAL DEPARTMENT WITH A NOTE THAT INDICATED BROKEN. 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 EFFECTS OR DELAYS IN CRITICAL THERAPY. NO MEDICAL INTERVENTION WERE IMPLEMENTED. DURING TESTING AT THE USER FACILITY, A BURNING SMELL WAS NOTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156846 PLUM XL PLS MIC/MAC 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK