BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARSTAR PUMP

    MDR report key: 3813342 · Received May 15, 2014

    Report

    Report Number
    9610175-2014-00010
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    April 16, 2014
    Report Date
    April 16, 2014
    Manufacturer
    FRANTZ MEDICAL DEVELOPMENT LTD.
    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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE (B)(4) AFFILIATE ATTEMPTED THREE TIMES TO HAVE THE PUMP UPLIFTED AND RETURNED TO ABBOTT FOR PRODUCT EVALUATION. MOTHER CONFIRMED THE PUMP IS WORKING FINE AND THERE WAS AN USE ERROR WHEN SETTING UP THE PUMP FOR ADMINISTRATION OF ENTERAL PRODUCT.

    Description of Event or Problem · 1

    THE RATE WAS SET AT 62 ML PER HOUR AND AFTER ONE HOUR, MOTHER NOTICED THAT ONLY 28 ML HAD BEEN DELIVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290017 CLEARSTAR PUMP PUMP, INFUSION, ENTERAL LZH FRANTZ MEDICAL DEVELOPMENT LTD. 20

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR