BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARSTAR PUMP

    MDR report key: 3909566 · Received July 2, 2014

    Report

    Report Number
    1527460-2014-00003
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Date of Event
    June 10, 2014
    Report Date
    July 2, 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). INSUFFICIENT FLOW OR UNDER INFUSION. NO CONSEQUENCE OR IMPACT TO PATIENT. THE DEVICE REPORTED, LIST NUMBER (B)(4), IS AN ABBOTT PRODUCT THAT IS MARKETED INTERNATIONALLY, WHICH IS THE SAME OR SIMILAR TO A DEVICE, LIST NUMBER (B)(4), THAT IS MARKETED DOMESTICALLY. ABBOTT NUTRITION STANDARD PROCEDURE INCLUDES ATTEMPTING TO OBTAIN ALL REQUIRED INFORMATION FROM THE SOURCE. A DELIVERY ACCURACY TEST COULD NOT BE PERFORMED DUE TO THE PUMP EXPERIENCING AN F-05 ALARM DUE TO A FAULTY REED SWITCH AND MOTOR.

    Description of Event or Problem · 1

    COMPLAINANT REPORTED AN UNDER DELIVERY. THE PUMP SHOULD HAVE DELIVERED 1300 ML BUT ONLY DELIVERED 100 ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387323 CLEARSTAR PUMP PUMP, INFUSION, ENTERAL LZH FRANTZ MEDICAL DEVELOPMENT LTD. 20

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR