BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARSTAR PUMP

    MDR report key: 1950121 · Received December 9, 2010

    Report

    Report Number
    1527460-2010-00201
    Event Type
    Malfunction
    Date Received
    December 9, 2010
    Date of Event
    November 10, 2010
    Report Date
    November 11, 2010
    Manufacturer
    ABBOTT NUTRITION
    Product Code
    LZH
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE DEVICE REPORTED, LIST NUMBER 55238, 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 INFO FROM THE SOURCE.

    Description of Event or Problem · 1

    SAME CASE AS 1527460-2010-00198, 00199 AND 00200. THE COMPLAINANT REPORTED AN OVER-DELIVERY. THE INTENDED DELIVERY WAS 200ML OVER 4 HRS AT A RATE OF 45ML/HR; HOWEVER, THE ACTUAL AMOUNT RECEIVED WAS 200ML IN 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLEARSTAR PUMP LZH, PUMP, INFUSION, ENTERAL LZH ABBOTT NUTRITION 55238

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR