BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARSTAR PUMP

    MDR report key: 1203436 · Received October 15, 2008

    Report

    Report Number
    1527460-2008-00882
    Event Type
    Malfunction
    Date Received
    October 15, 2008
    Date of Event
    January 1, 2008
    Report Date
    September 23, 2008
    Manufacturer
    ABBOTT NUTRITION
    Product Code
    LZH
    PMA / PMN Number
    K981541
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REPORTED IS AN ABBOTT PRODUCT THAT IS MARKETED INTERNATIONALLY WHICH IS THE SAME OR SIMILAR TO A DEVICE THAT IS MARKETED DOMESTICALLY. ABBOTT NUTRITION STANDARD PROCEDURE INCLUDES ATTEMPTING TO OBTAIN ALL REQUIRED INFO FROM THE SOURCE.

    Description of Event or Problem · 1

    COMPLAINANT REPORTED AN UNDER-DELIVERY PROBLEM WITH THE PUMP. THE INTENDED DELIVERY RATE WAS 170 ML/HR. THE ACTUAL DELIVERY WAS 125 ML/HR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLEARSTAR PUMP LZH PUMP, INFUSION, ENTERAL LZH ABBOTT NUTRITION 55239

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR