BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIS VISTA MONITOR

    MDR report key: 1668382 · Received April 22, 2010

    Report

    Report Number
    1221611-2010-00003
    Event Type
    Other
    Date Received
    April 22, 2010
    Date of Event
    December 29, 2009
    Report Date
    March 23, 2010
    Manufacturer
    ASPECT MEDICAL SYSTEMS
    Product Code
    GWQ
    PMA / PMN Number
    K052362
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ELECTRONIC BIS TREND WAS ANALYZED. IT APPEARS THAT THE PROMINENT INCREASES IN BIS WERE ASSOCIATED WITH CHANGES IN THE EEG POWER SPECTRUM (25-47 HZ). POSSIBLE CAUSES FOR THE PEAK IN THE POWER SPECTRUM THAT CAUSED THE INCREASES IN BIS INCLUDE EITHER A TRUE PATIENT AROUSAL, OR AN UNIDENTIFIED ELECTRONIC SOURCE OF HIGH-FREQUENCY CONTAMINATION. WITH THE ABSENCE OF THE ANESTHESIA RECORD OR FURTHER CLINICAL DETAILS IT IS UNKNOWN WHAT MAY HAVE CAUSED THE ELEVATED BIS NUMBER. THE SERIAL NUMBER OF THE BIS MODULE WHICH WAS USED IN PLACE OF THE VISTA MONITORING SYSTEM IS UNKNOWN; THEREFORE, AN ELECTRONIC BIS TREND WAS NOT AVAILABLE NOR WAS THE UNIT AVAILABLE FOR INVESTIGATION. THE VISTA MONITORING SYSTEM WAS RETURNED FOR EVALUATION. NO PROBLEM WAS FOUND. THE VISTA MONITORING SYSTEM DEVICE HISTORY RECORD WAS REVIEWED; NO PROBLEM WAS FOUND. DEVICE FUNCTIONED AS INTENDED AND DID NOT MALFUNCTION. THE VISTA OPERATING MANUAL STATES: "BIS IS A COMPLEX MONITORING TECHNOLOGY INTENDED FOR USE AS AN ADJUNCT TO CLINICAL JUDGMENT AND TRAINING. CLINICAL JUDGMENT SHOULD ALWAYS BE USED WHEN INTERPRETING BIS IN CONJUNCTION WITH OTHER AVAILABLE CLINICAL SIGNS. RELIANCE ON BIS ALONE FOR INTRAOPERATIVE ANESTHETIC MANAGEMENT IS NOT RECOMMENDED. AS WITH ANY MONITORED PARAMETER, ARTIFACTS AND POOR SIGNAL QUALITY MAY LEAD TO INAPPROPRIATE BIS VALUES. POTENTIAL ARTIFACTS MAY BE CAUSED BY POOR SKIN CONTACT (HIGH IMPEDANCE), MUSCLE ACTIVITY OR RIGIDITY, HEAD AND BODY MOTION, SUSTAINED EYE MOVEMENTS, IMPROPER SENSOR PLACEMENT AND UNUSUAL OR EXCESSIVE ELECTRICAL INTERFERENCE". BASED ON OUR INVESTIGATION WHICH IS LIMITED BY THE INFORMATION PROVIDED BY THE REPORTING HOSPITAL, WE ARE UNABLE TO DETERMINE IF BIS MONITORING CAUSED OR CONTRIBUTED TO A DEATH, PERMANENT DAMAGE TO A BODY STRUCTURE OR PERMANENT IMPAIRMENT OF A BODY FUNCTION. WE WERE UNABLE TO REVEAL ANY EVIDENCE OF MONITOR MALFUNCTION. HOWEVER, THE INVOLVED ANESTHESIOLOGIST CONSIDERED THE MONITOR PERFORMANCE REPRESENTED A CRITICAL INCIDENT DUE TO HIS ADMINISTRATION OF ADDITIONAL ANESTHETIC ADMINISTRATION IN RESPONSE TO AN ELEVATED BIS NUMBER. BECAUSE WE CANNOT EXCLUDE ANY UNTOWARD PATIENT INJURY FROM THIS ANESTHETIC ADMINISTRATION, AN MDR IS REQUIRED.

    Description of Event or Problem · 1

    ON (B)(4) 2010, ASPECT MEDICAL SYSTEMS RECEIVED NOTIFICATION OF AN INCIDENT WHICH OCCURRED ON (B)(6) 2010. PER RN FROM THE SITE, THE FOLLOWING DETAILS WERE PROVIDED: THE PATIENT HAD BEEN ANESTHETIZED FOR ABOUT 10 MINUTES WITH A TIVA ANESTHETIC WHILE A BIS MONITOR WAS BEING USED. THE BIS READING WENT DOWN TO 63 THEN SUDDENLY JUMPED UP TO 82. THE ANESTHESIOLOGIST REQUESTED THE SURGEON NOT TO MAKE AN INCISION UNTIL THE ANESTHESIOLOGIST CHECKED THAT THE BIS READING WAS ACCURATE. THE ANESTHESIOLOGIST GAVE MORE PROPOFOL BUT THE BIS READING DIDN'T CHANGE. THE ANESTHESIOLOGIST SUGGESTED THE RN RETRIEVE ANOTHER BIS MONITOR. THE ANESTHESIOLOGIST EXCHANGED THE BIS MONITOR FOR A BIS MODULE. THE READING OF THE BIS MODULE WAS 4 WHICH THE ANESTHESIOLOGIST THOUGHT WAS VERY LOW. TO TEST THE DIFFERENCE, THE ANESTHESIOLOGIST PLUGGED THE FIRST MONITOR IN AGAIN AND THE READING WAS 82. THE TIME PERIODS BETWEEN THESE OBSERVATIONS, AS WELL AS THE ANESTHETIC AGENTS ADMINISTERED WERE NOT PROVIDED BY THE REPORTING HOSPITAL. THE REASON THE ANESTHESIOLOGIST REPORTED THIS AS A CRITICAL INCIDENT IS BECAUSE OF THE FAILURE OF THE FIRST MONITOR TO GIVE AN ACCURATE READING, SO THE ANESTHESIOLOGIST GAVE MORE ANESTHETIC BELIEVING THE MONITOR WAS ACCURATE WHICH IN FACT MEANT THE PATIENT WAS GIVEN TOO MUCH ANESTHETIC PUTTING THE PATIENT'S LIFE AT RISK. NO FURTHER DETAILS ARE AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIS VISTA MONITOR EEG MONITOR GWQ ASPECT MEDICAL SYSTEMS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other