BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM A+ DRIVER NEW 8

    MDR report key: 2160441 · Received June 20, 2011

    Report

    Report Number
    9615050-2011-00444
    Event Type
    Malfunction
    Date Received
    June 20, 2011
    Date of Event
    May 19, 2011
    Report Date
    May 25, 2011
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K042081
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED UNRESTRICTED FLOW. THE PUMP WAS RETURNED TO THE BIOMEDICAL ENGINEERING DEPARTMENT WITH AN UNSIGNED NOTE THAT STATED, "BROKE." NO TRACKING INFO WAS PROVIDED; THEREFORE, SPECIFIC PT INFO, PUMP PROGRAMMING, OR EVENT DETAILS WERE NOT AVAILABLE. DURING TESTING AT THE USER FACILITY, UNRESTRICTED FLOW WAS NOTED WHEN THE DOOR WAS OPENED. THERE WERE NO REPORTS OF ANY ADVERSE PT EVENTS AND NO REPORTED DELAYS OF CRITICAL THERAPIES WHILE THE DEVICE/PUMP WAS IN CLINICAL USE. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLUM A+ DRIVER NEW 8 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

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