BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRA OPTIA

    MDR report key: 6474167 · Received April 7, 2017

    Report

    Report Number
    1722028-2017-00140
    Event Type
    Malfunction
    Date Received
    April 7, 2017
    Date of Event
    March 15, 2017
    Report Date
    April 7, 2017
    Manufacturer
    TERUMO BCT
    Product Code
    LKN
    PMA / PMN Number
    K153601
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THIS UNIT SHOWED NO IRREGULARITIES DURING MANUFACTURING THAT WERE RELEVANT TO THIS ISSUE. ROOT CAUSE: A DEFINITIVE ROOT CAUSE FOR THE PATIENT REACTION COULD NOT BE DETERMINED. THE DEVICE OPERATED AS INTENDED. POSSIBLE CAUSES FOR THE ALLEGED VASOVAGAL REACTION INCLUDE BUT ARE NOT LIMITED TO PATIENT DISEASE STATE AND/OR PATIENT SENSITIVITY TO THE PROCEDURE. THERE WERE MANY CHANGES MADE TO THE INLET FLOW RATE DURING THIS RUN AND WITH THE SETTINGS THAT THE SYSTEM WAS USING TO COMPLETE THIS PROCEDURE, THE DESIRED TARGET OF 100% FLUID BALANCE WAS NOT ABLE TO BE ACHIEVED AT THAT POINT IN THE RUN. THE SYSTEM TRACKS THE PATIENT¿S FLUID BALANCE THROUGHOUT THE RUN AND TAKES INTO ACCOUNT ADDED VOLUME FROM BOLUSES GIVEN DURING THE PROCEDURE. WHEN THE THIRD BOLUS WAS ORDERED AT 131 MINUTES, THE SYSTEM DID NOT ALLOW IT TO BE ADMINISTERED BECAUSE DELIVERY OF THE ORDERED VOLUME WOULD HAVE EXCEEDED THE 125% FLUID BALANCE THAT IS SET AS AN UPPER LIMIT IN ORDER TO MAINTAIN PATIENT SAFETY. AT THIS TIME, THE SYSTEM DISPLAYED THE ¿BOLUS VOLUME CAUSED FLUID BALANCE TO EXCEED LIMITS¿ ALARM. THE SYSTEM OPERATED AS INTENDED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: THE CUSTOMER INITIALLY CONTACTED TERUMO BCT SUPPORT LINE BECAUSE THE RN WAS UNABLE TO ENTER A FLUID BALANCE OF 100% AFTER GIVING THE PATIENT 3 BOLUSES. THE RUN DATA FILE (RDF) WAS ANALYZED FOR THIS EVENT. SIGNALS IN THE RDF SHOWED THAT THE DEVICE OPERATED AS INTENDED. ACCORDING TO THERAPEUTIC APHERESIS: A PHYSICIAN'S HANDBOOK, ADVERSE EVENTS OCCUR DURING THERAPEUTIC PROCEDURES WITH A FREQUENCY OF 4.8%. VASOVAGAL INCIDENTS OCCUR AROUND 0.5% OF PROCEDURES. THE REACTIONS GENERALLY MANIFEST AS PALLOR AND DIAPHORESIS. IN A FULL BLOWN ATTACK, THE REACTION PROGRESSES FROM PALLOR AND SWEATING TO PULSE SLOWING AND BLOOD PRESSURE DECREASING. MORE SEVERE VASOVAGAL REACTIONS MAY INCLUDE NAUSEA, VOMITING, AND/OR CONVULSIONS. INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A THERAPEUTIC PLASMA EXCHANGE (TPE) PROCEDURE, THE PATIENT'S BLOOD PRESSURE DECREASED APPROXIMATELY TO 80/40 MMHG. PER PHYSICIAN'S ORDER, THE RN GAVE THE PATIENT A BOLUS OF 500ML OF NORMAL SALINE(NS) AND 2 BOLUS OF 250ML OF NS. PER THE CUSTOMER, THE PATIENT'S BLOOD PRESSURE BASELINED TO 89/50 MMHG. THE CUSTOMER DECLINED TO PROVIDE PATIENT IDENTIFIER (ID).THE EXCHANGE SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253439 SPECTRA OPTIA SPECTRA OPTIA EXCHANGE SET LKN TERUMO BCT 01A3127

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention