BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMBRACE PUMP

    MDR report key: 1011668 · Received March 10, 2008

    Report

    Report Number
    1527460-2008-00378
    Event Type
    Malfunction
    Date Received
    March 10, 2008
    Manufacturer
    ROSS PRODUCTS DIVISION
    Product Code
    LZH
    PMA / PMN Number
    K031407
    Removal / Correction Number
    Z-1141-2007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BROKEN PIVOT POINT CONFIRMED IN THE LABORATORY. ABBOTT STANDARD PROCEDURE INCLUDES ATTEMPTING TO OBTAIN ALL REQUIRED INFORMATION FROM THE SOURCE.

    Description of Event or Problem · 1

    CRACKED OR BROKEN PIVOT POINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EMBRACE PUMP 80 LZH PUMP, INFUSION, ENTERAL LZH ROSS PRODUCTS DIVISION 55336

    Patients

    Seq Age Sex Outcome Treatment
    1