BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARSTAR PUMP

    MDR report key: 2911425 · Received January 11, 2013

    Report

    Report Number
    1527460-2013-00003
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    December 14, 2012
    Report Date
    December 14, 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 DID NOT CONFIRM THE COMPLAINT OF UNDER-DELIVERY. THE PUMP DELIVERED AT A +2.46% ACCURACY, WHICH IS WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    THE COMPLAINANT REPORTED AN UNDER-DELIVERY. THE PUMP WAS SET TO DELIVER 325 ML; HOWEVER, WHEN THE PUMP ALARMED COMPLETE, THERE WAS APPROXIMATELY 200 ML LEFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16681 CLEARSTAR PUMP LZH ABBOTT NUTRITION M771

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO