BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISTA BASIC SAFETY INFUSION SYSTEM

    MDR report key: 2062237 · Received March 17, 2011

    Report

    Report Number
    1641965-2011-00019
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    February 16, 2011
    Report Date
    February 18, 2011
    Manufacturer
    B. BRAUN MEDICAL, INC
    Product Code
    FRN
    PMA / PMN Number
    K003029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVALUATION IS CURRENTLY UNDERWAY. A FOLLOW-UP REPORT WILL BE INITIATED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    PUMP DID NOT GIVE OCCLUSION ALARM. NO PT INJURY REPORTED. PUMP WAS SET UP FOR AN INFUSION. NURSE ACCIDENTALLY LEFT THE LINE CLAMPED. HOWEVER, THE PUMP RAN FOR 2.5 HRS WITHOUT GIVING AN OCCLUSION ALARM. THE PUMP DID NOT RECOGNIZE THAT NOTHING WAS INFUSING AND ACTED LIKE IT WAS RUNNING. AFTER SITUATION WAS DISCOVERED, THE PUMP WAS TAKEN OFFLINE. PUMP WAS SET TO DELIVER 220ML/HR. CARE AREA: DIALYSIS. TYPE OF THERAPY: IPDN/NUTRITION. IV CONTAINER WAS FULL FOLLOWING INCIDENT. IV SET WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISTA BASIC SAFETY INFUSION SYSTEM INFUSION PUMP FRN B. BRAUN MEDICAL, INC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK