BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLM A+3 MEDNET WRLSS

    MDR report key: 2062242 · Received March 17, 2011

    Report

    Report Number
    9615050-2011-00164
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    November 1, 2010
    Report Date
    November 16, 2010
    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
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES WERE NOT ISOLATED OR IDENTIFIED BY SERIAL NUMBER; THEREFORE, THEY WILL NOT BE RETURNED FOR INVESTIGATION. THE DEVICES WERE NOT RETURNED TO HOSPIRA FOR TESTING AND INVESTIGATION; THEREFORE, ATTRIBUTION OF THE ISSUE TO THE DEVICES COULD NOT BE DETERMINED. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL. (B)(4).

    Description of Event or Problem · 1

    GENERAL REPORT RECEIVED OF AN UNSPECIFIED NUMBER OF UNDOCUMENTED INCIDENTS OF PTS RECEIVING MORE MEDICATION THAN INTENDED. THE CUSTOMER CONTACT REPORTED THAT WHEN USING SYRINGES ON THE SECONDARY PORTS OF CASSETTES, PTS RECEIVED MORE MEDICATION THAN INTENDED. NO TRACKING INFO WAS PROVIDED; THEREFORE, SPECIFIC PT INFO, DEVICE PROGRAMMING, OR EVENT DETAILS WERE NOT AVAILABLE. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED INCLUDING IF THERE WERE REPORTS OF ANY ADVERSE PT EVENTS WHILE THE DEVICES WERE IN CLINICAL USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLM A+3 MEDNET WRLSS 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK