BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GRASEBY 500 VOLUMETRIC INFUSION PUMP

    MDR report key: 2140364 · Received June 17, 2011

    Report

    Report Number
    2183502-2011-00481
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    January 1, 2011
    Report Date
    June 15, 2011
    Manufacturer
    SMITHS MEDICAL INTL. LTD.
    Product Code
    FRN
    PMA / PMN Number
    K940446
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MFR FOR DEVICE EVAL. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED, THE MFR WILL FILE A F/U REPORT DETAILING THE RESULTS OF THE EVAL.

    Description of Event or Problem · 1

    USER FACILITY REPORTED THAT THE PUMP WAS PROGRAMMED TO INFUSE 1000 ML OVER A 12-HOUR PERIOD: MEDICATION TYPE NOT REPORTED. THE INFUSION COMPLETED WITHIN 1.5 HOURS. NO ADVERSE EFFECTS TO PT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GRASEBY 500 VOLUMETRIC INFUSION PUMP FRN SMITHS MEDICAL INTL. LTD. 500 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK