BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM A+ DRIVER REFU

    MDR report key: 3832342 · Received February 10, 2014

    Report

    Report Number
    9615050-2014-01050
    Event Type
    Malfunction
    Date Received
    February 10, 2014
    Date of Event
    January 16, 2014
    Report Date
    January 16, 2014
    Manufacturer
    HOSPIRACOSTA 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

    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 THE DEVICE DOOR ROLLER WAS BROKEN. THE DEVICE WAS RETURNED TO THE BIOMEDICAL DEPARTMENT FOR A REPORT OF BROKEN DOOR ROLLER AND N810 ERROR. 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 THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. DURING TESTING AT THE USER FACILITY, IT WAS NOTED THAT THE DEVICE DOOR ROLLER WAS BROKEN. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87941 PLUM A+ DRIVER REFU 80FRN FRN HOSPIRACOSTA RICA LTD. NA NA

    Patients

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