BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARSTAR PUMP

    MDR report key: 2760551 · Received September 26, 2012

    Report

    Report Number
    1527460-2012-00058
    Event Type
    Malfunction
    Date Received
    September 26, 2012
    Date of Event
    August 30, 2012
    Report Date
    August 30, 2012
    Manufacturer
    ABBOTT NUTRITION
    Product Code
    LZH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).: THE DEVICE REPORTED, LIST NUMBER M771, IS AN ABBOTT PRODUCT THAT IS MARKETED INTERNATIONALLY, WHICH IS THE SAME OR SIMILAR TO A DEVICE, LIST NUMBER 55239, THAT IS MARKETED DOMESTICALLY. ABBOTT NUTRITION STANDARD PROCEDURE INCLUDES ATTEMPTING TO OBTAIN ALL REQUIRED INFORMATION FROM THE SOURCE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE TESTING AND INVESTIGATION RESULTS DID NOT CONFIRM THE COMPLAINT OF UNDER-DELIVERY. THE PUMP DELIVERED AT -0.5% ACCURACY, WHICH IS WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    THE COMPLAINANT REPORTED AN UNDER-DELIVERY. THE INTENDED DELIVERY WAS 170 ML AT A RATE OF 170 ML/HOUR; HOWEVER, AFTER ONE HOUR, 100 ML REMAINED IN THE BOTTLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR