BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT SPACE

    MDR report key: 1840066 · Received September 15, 2010

    Report

    Report Number
    1641965-2010-00044
    Event Type
    Malfunction
    Date Received
    September 15, 2010
    Report Date
    August 13, 2010
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    FRN
    PMA / PMN Number
    K062700
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PUMPS HAVE BEEN RETURNED FOR EVALUATION TO DATE. ATTEMPTS WILL BE MADE TO RETRIEVE THE PUMPS AND GAIN MORE INFORMATION ABOUT THE INCIDENT. A FOLLOW-UP WILL BE PROVIDED IF MORE INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    PIR - MONITOR INTERFERENCE. WHILE DOING AN EEG ON A PATIENT, THERE WAS CONSIDERABLE NOISE AND A CONTINUOUS PULSE MAKING THE EEG UNREADABLE. THE PATIENT HAD 6 B. BRAUN PUMPS RUNNING. AS SOON AS THE PUMPS WERE UNPLUGGED, THE NOISE DISAPPEARED. THIS HAS HAPPENED PREVIOUSLY BUT THIS IS THE FIRST TIME IT HAS BEEN REPORTED TO THE MANUFACTURER. WITH THE 6 PUMPS RUNNING, THE BASE LINE HAD AN AMPLITUDE OF ONE INCH ON THE EEG DISPLAY. PER THE EEG TECH, THE MORE PUMPS THE GREATER THE AMPLITUDE. EVEN WITH A PUMP UNPLUGGED, THEY INTERMITTENTLY SEE A PULSE THAT COINCIDES WITH THE "DRIPS". IT HAS OCCURRED THROUGHOUT THE BUILDING AND WITH OR WITHOUT BEING HOUSED IN THE SPACE MODULE OR AS A STAND ALONE UNIT. THIS WOULD SEEM TO ELIMINATE THE POSSIBILITY OF A GROUNDED POWER CORD PREVENTING THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSOMAT SPACE INFUSION PUMP FRN B. BRAUN MEDICAL, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 (B)(4)