BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM XL3 PLS MIC/MAC

    MDR report key: 1950250 · Received December 13, 2010

    Report

    Report Number
    2921482-2010-00988
    Event Type
    Malfunction
    Date Received
    December 13, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 18, 2010
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    PMA / PMN Number
    K952799
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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 INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED SPARKS, MELTING AND CHARRING. THE DEVICE WAS RETURNED TO THE BIOMEDICAL ENGINEERING DEPARTMENT WITH AN UNSIGNED NOTE THAT STATED, "DOES NOT RECOGNIZE THE CASSETTE." NO TRACKING INFO WAS PROVIDED; THEREFORE, SPECIFIC PT INFO, PUMP PROGRAMMING, OR EVENT DETAILS WERE NOT AVAILABLE. DURING TESTING AT THE USER FACILITY, WHEN THE AC POWER CORD WAS PLUGGED INTO THE AC RECEPTACLE, "SPARKS" WERE NOTED INSIDE OF THE PLASTIC PLUG ON THE MALE END OF THE AC POWER CORD. THE DEVICE WAS UNPLUGGED FROM THE AC RECEPTACLE. UPON FURTHER INSPECTION, MELTING WAS NOTED AT THE STRAIN RELIEF ON THE FEMALE END OF THE AC POWER CORD AND THE FUSES WERE BLOWN IN THE DEVICE. THERE WAS NO REPORT OF ADVERSE EVENT TO THE BIOMEDICAL ENGINEER. NO MEDICAL INTERVENTIONS WERE REQUIRED. THERE WERE NO REPORTS OF ANY ADVERSE PT EVENTS AND NO REPORTED DELAYS OF CRITICAL THERAPIES 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 XL3 PLS MIC/MAC 80FRN FRN HOSPIRA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1