BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARSTAR PUMP

    MDR report key: 2191151 · Received July 25, 2011

    Report

    Report Number
    1527460-2011-00052
    Event Type
    Malfunction
    Date Received
    July 25, 2011
    Date of Event
    June 30, 2011
    Report Date
    June 30, 2011
    Manufacturer
    ABBOTT NUTRITION
    Product Code
    LZH
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE REPORTED, (B)(4) IS AN ABBOTT PRODUCT THAT IS MARKETED INTERNATIONALLY WHICH IS THE SAME OR SIMILAR TO A DEVICE, (B)(4), THAT IS MARKETED DOMESTICALLY. ABBOTT NUTRITION STANDARD PROCEDURE INCLUDES ATTEMPTING TO OBTAIN ALL REQUIRED INFO FROM THE SOURCE.

    Description of Event or Problem · 1

    THE COMPLAINANT REPORTED AN UNDER-DELIVERY. THE INTENDED DELIVERY AMOUNT WAS 200ML AT A RATE OF 50ML/HR OVER A TIME FRAME OF 4 HOURS; HOWEVER, THE ACTUAL AMOUNT RECEIVED WAS 100ML IN A 4 HOUR PERIOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLEARSTAR PUMP LZH, PUMP, INFUSION, ENTERAL LZH ABBOTT NUTRITION M771

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR