BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARSTAR PUMP

    MDR report key: 1003497 · Received February 21, 2008

    Report

    Report Number
    1527460-2008-00255
    Event Type
    Malfunction
    Date Received
    February 21, 2008
    Report Date
    January 23, 2008
    Manufacturer
    ROSS PRODUCTS DIVISION
    Product Code
    LZH
    PMA / PMN Number
    K981541
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE COMPLAINANT REPORTED AN OVER-DELIVERY. THE PUMP WAS SET FOR 40 MLS/HR AND DELIVERED 200 MLS IN 1.45 HRS. THE PUMP ALARMED WHEN EMPTY. THE PATIENT VOMITED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLEARSTAR PUMP 80 LZH PUMP, INFUSION, ENTERAL LZH ROSS PRODUCTS DIVISION 55239

    Patients

    Seq Age Sex Outcome Treatment
    1 18 MO