BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARSTAR PUMP

    MDR report key: 3624246 · Received February 12, 2014

    Report

    Report Number
    9610175-2014-00003
    Event Type
    Malfunction
    Date Received
    February 12, 2014
    Date of Event
    January 14, 2014
    Report Date
    January 14, 2014
    Manufacturer
    FRANTZ MEDICAL DEVELOPMENT LTD.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE TESTING AND INVESTIGATION RESULTS DO NOT CONFIRM THE COMPLAINT OF UNDER DELIVERY. THE PUMP DELIVERED AT A 100% ACCURACY, WHICH IS WITHIN SPECIFICATION OF THE PUMP.

    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.

    Description of Event or Problem · 1

    THE COMPLAINANT REPORTED AN UNDER DELIVERY. THE PUMP WAS SET TO DELIVER 480 ML; HOWEVER, WHEN THE PUMP RAN FOR EIGHT HOURS, ONLY 50 ML HAD BEEN DELIVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91682 CLEARSTAR PUMP FPA FRANTZ MEDICAL DEVELOPMENT LTD. 20

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR