BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARSTAR PUMP

    MDR report key: 3063627 · Received April 17, 2013

    Report

    Report Number
    1527460-2013-00039
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Date of Event
    March 21, 2013
    Report Date
    March 21, 2013
    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 PATIENT'S WIFE CONTACTED ABBOTT TO WITHDRAW THE COMPLAINT AGAINST THE PUMP STATING IT WAS USE ERROR RELATED TO THE LOADING AND PRIMING OF THE FEEDING SET. THE PUMP IS WORKING FINE, AND SHE DOES NOT WISH TO RETURN IT FOR EVALUATION.

    Description of Event or Problem · 1

    THE COMPLAINANT REPORTED AN UNDER-DELIVERY. THE INTENDED DELIVERY WAS 1500 ML AT A RATE OF 150 ML/HOUR FOR 10 HOURS; HOWEVER, THE ACTUAL DELIVERY VOLUME WAS 700 ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165268 CLEARSTAR PUMP LZH ABBOTT NUTRITION M771

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR