BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDFUSION 3500 SYRINGE INFUSON PUMP

    MDR report key: 967717 · Received March 21, 2007

    Report

    Report Number
    2183502-2007-00080
    Event Type
    Malfunction
    Date Received
    March 21, 2007
    Manufacturer
    SMITHS MEDICAL MD
    Product Code
    FRN
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICES WERE NOT RETURNED FOR EVAL FROM THE FACILITY, BUT THE MFR WAS ABLE TO SIMULATE THE REPORTED PROBLEM USING THE FACILITY'S CONFIGURATION FILES. THE DEVICES DID HAVE THE POTENTIAL TO "LOCK UP" DURING POWER UP IF THE FACILITY WAS USING LARGE CONFIGURATION FILES AND THE SCHEDULED CONFIGURED PREVENTIVE MAINTENANCE ALARM WAS SET TO EXPIRE WITHIN THE NEXT MO. A SHORT-TERM FIX HAS BEEN ESTABLISHED WHERE A CUSTOMER INFO BULLETIN (CIB) WAS SENT OUT TO THE BIOMEDICAL ENGINEERS USING THE MEDFUSION 3500 SYRINGE INFUSION PUMP WITH PHARMGUARD MEDICATION SAFETY SOFTWARE V4.1.3 AND V4.1.4. THE CIB NOTIFIED THE BIOMEDICAL ENGINEERS OF THE SOFTWARE ANOMALY WHERE A PUMP MAY NOT BE ABLE TO COMPLETE ITS POWER UP ROUTINE AND LOCK UP WHEN THE PUMP'S PREVENTIVE MAINTENANCE (PM) ALARM OCCURS. WHEN THIS HAPPENS, IT REQUIRES THE PM DATE TO BE RESET USING THE BIOMED FEATURE. THE LONG TERM FIX WILL BE ADDRESSED IN THE NEXT SOFTWARE RELEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDFUSION 3500 SYRINGE INFUSON PUMP SYRINGE INFUSION PUMP FRN SMITHS MEDICAL MD * *

    Patients

    Seq Age Sex Outcome Treatment
    1