BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARSTAR PUMP

    MDR report key: 3130469 · Received May 24, 2013

    Report

    Report Number
    1527460-2013-00054
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Date of Event
    April 25, 2013
    Report Date
    April 25, 2013
    Manufacturer
    ABBOTT NUTRITION - COLUMBUS
    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 +6% ACCURACY, WHICH IS IN SPECIFICATION.

    Description of Event or Problem · 1

    THE COMPLAINANT REPORTED AN UNDER-DELIVERY. THE INTENDED DELIVERY WAS 2625 ML AT A RATE OF 125 ML/HOUR FOR 12 HOURS; HOWEVER THE ACTUAL DELIVERY VOLUME WAS 1400 ML IN 21 HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231895 CLEARSTAR PUMP LZH ABBOTT NUTRITION - COLUMBUS M771

    Patients

    Seq Age Sex Outcome Treatment
    1