BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LC PCA NEW 802.11 AB

    MDR report key: 1961616 · Received December 27, 2010

    Report

    Report Number
    2921482-2010-01027
    Event Type
    Malfunction
    Date Received
    December 27, 2010
    Date of Event
    December 1, 2010
    Report Date
    December 13, 2010
    Manufacturer
    HOSPIRA, INC.
    Product Code
    MEA
    PMA / PMN Number
    K042800
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING OF THE DEVICE WAS CONDUCTED AT THE USER FACILITY BY THE FIELD SERVICE ENGINEER ON (B)(4) 2010. THE DEVICE PASSED TESTING BY DELIVERING A DOSE WHEN THE PATIENT PENDANT WAS PRESSED. THE DEVICE WAS NOT RETURNED TO HOSPIRA FOR TESTING AND INVESTIGATION; THEREFORE, ATTRIBUTION OF THE ISSUE TO THE DEVICE 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

    THE CUSTOMER CONTACT REPORTED THE DEVICE DID NOT DELIVER A DOSE WHEN THE PATIENT PENDANT WAS PRESSED. THE DEVICE WAS RETURNED TO THE BIOMEDICAL ENGINEERING DEPARTMENT WITH AN UNSIGNED NOTE THAT STATED, "PATIENT PENDANT NOT WORKING." NO TRACKING INFO WAS PROVIDED; THEREFORE, SPECIFIC PATIENT INFO, PUMP PROGRAMMING, OR EVENT DETAILS WERE NOT AVAILABLE. THERE WERE NO REPORTS OF ANY ADVERSE PATIENT 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 LC PCA NEW 802.11 AB 80MEA MEA HOSPIRA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK