BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARSTAR PUMP

    MDR report key: 2920010 · Received January 17, 2013

    Report

    Report Number
    1527460-2013-00009
    Event Type
    Malfunction
    Date Received
    January 17, 2013
    Date of Event
    December 21, 2012
    Report Date
    December 21, 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

    MFG. EVENT ID: #(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

    MFG. EVENT ID: (B)(4). THE TESTING AND INVESTIGATION RESULTS DID NOT CONFIRM THE COMPLAINT OF UNDER-DELIVERY. THE PUMP DELIVERED AT -3% ACCURACY, WHICH IS WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    THE COMPLAINANT REPORTED AN UNDER-DELIVERY. THE PUMP WAS SET TO DELIVER 150 ML AT A RATE OF 200 ML PER HOUR; HOWEVER, THE ACTUAL DELIVERY VOLUME WAS APPROXIMATELY 50 ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27139 CLEARSTAR PUMP LZH ABBOTT NUTRITION M771

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR