BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARSTAR PUMP

    MDR report key: 1063033 · Received June 19, 2008

    Report

    Report Number
    1527460-2008-00830
    Event Type
    Malfunction
    Date Received
    June 19, 2008
    Date of Event
    May 13, 2008
    Report Date
    May 20, 2008
    Product Code
    LZH
    PMA / PMN Number
    K981541
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ROSS STANDARD PROCEDURE INCLUDES ATTEMPTING TO OBTAIN ALL REQUIRED INFO FROM THE SOURCE.

    Description of Event or Problem · 1

    COMPLAINANT REPORTS AN UNDER DELIVERY. IT WAS REPORTED THAT THE INTENDED DELIVERY WAS 900 ML OVER A TIME FRAME OF 10 HOURS AT A RATE OF 90 ML/HR. THE REPORTER STATED THAT THE ACTUAL AMOUNT DELIVERED WAS 0 MLS/HR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLEARSTAR PUMP LZH PUMP, INFUSION ENTERAL LZH 55239

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR