BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LC 5000 W/DATAPORT

    MDR report key: 1954619 · Received December 15, 2010

    Report

    Report Number
    2921482-2010-01011
    Event Type
    Malfunction
    Date Received
    December 15, 2010
    Date of Event
    November 2, 2010
    Report Date
    November 18, 2010
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    PMA / PMN Number
    K911401
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ATTACHMENT: USER FACILITY MANDATORY MEDWATCH WAS RECEIVED ON (B)(4) 2010. THE REPORT NUMBER IS (B)(4). AT THIS TIME THE CUSTOMER WILL NOT BE RETURNING THE DEVICE FOR EVALUATION. THE DEVICE PASSED TESTING AT THE USER FACILITY AND WAS RETURNED TO CLINICAL SERVICE. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL. (B)(4).

    Description of Event or Problem · 1

    USER FACILITY MANDATORY MEDWATCH RECEIVED FROM CDRH THAT STATED: "THE SECONDARY INFUSION OF LIPIDS BEEPED OFF OCCLUSION SEVERAL TIMES DURING NURSING SHIFT. THE INTENDED INFUSION VOLUME WAS 14 ML, ACTUAL INFUSION WAS 9 ML. THERE WAS NO PATIENT INJURY. INITIAL INFORMATION RECEIVED FROM THE CUSTOMER CONTACT INDICATED THE PATIENT RECEIVED LESS MEDICATION THAN INTENDED. DURING TESTING AT THE USER FACILITY, THE DEVICE PASSED ALL TESTING. INFORMATION WAS REQUESTED FROM THE CUSTOMER CONTACT INCLUDING SPECIFIC EVENT DETAILS AND IF THE THERAPY WAS RESUMED USING A REPLACEMENT PUMP. NO RESPONSE WAS RECEIVED. HOSPIRA IS CONTINUING TO INVESTIGATE THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LC 5000 W/DATAPORT 80FRN FRN HOSPIRA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO