BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LC PCA NEW 802.11 AB

    MDR report key: 1890098 · Received October 22, 2010

    Report

    Report Number
    2921482-2010-00822
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Date of Event
    September 14, 2010
    Report Date
    September 22, 2010
    Manufacturer
    HOSPIRA, INC.
    Product Code
    MEA
    PMA / PMN Number
    K042800
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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 INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL. (B)(4)

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THE PUMP DID NOT DELIVER A DOSE WHEN THE PATIENT PENDANT WAS PRESSED. THE PUMP WAS RETURNED TO THE BIOMEDICAL ENGINEERING DEPARTMENT WITH A NOTE THAT STATED, "PATIENT PENDANT NOT WORKING". NO SPECIFIC PATIENT INFORMATION, PUMP PROGRAMMING, OR EVENT DETAILS WERE PROVIDED. DURING TESTING AT THE USER FACILITY, THE PUMP DID NOT DELIVER A DOSE WHEN THE PATIENT PENDANT WAS PRESSED. A NEW PATIENT PENDANT WAS ATTACHED AND THE PUMP DID NOT DELIVER A DOSE WHEN THE PATIENT PENDANT WAS PRESSED. THERE WERE NO REPORTS OF ANY ADVERSE PATIENT EVENTS AND NO REPORTED DELAYS OF CRITICAL THERAPIES WHILE THE PUMP WAS IN CLINICAL USE. THOUGH REQUESTED, NO ADDITIONAL INFORMATION 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