BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRA OPTIA

    MDR report key: 6077168 · Received November 3, 2016

    Report

    Report Number
    1722028-2016-00591
    Event Type
    Malfunction
    Date Received
    November 3, 2016
    Date of Event
    December 23, 2015
    Report Date
    November 3, 2016
    Manufacturer
    TERUMO BCT
    Product Code
    LKN
    PMA / PMN Number
    BK130065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED TO PROVIDE ADDITIONAL INFORMATION . THE RUN DATA FILE (RDF) WAS REVIEWED FOR THIS RUN AS PART OF AN INTERNAL STUDY. IT WAS IDENTIFIED IN THE RDF THAT THE PATIENT WEIGHT AND HEIGHT MAY HAVE BEEN ENTERED INCORRECTLY, RESULTING IN AN UNREASONABLE BODY MASS INDEX. SUCH A DATA ENTRY ERROR CAN LEAD TO, IN SOME INSTANCES, AN OVER INFUSION OF AC OR A HYPERVOLEMIC OR HYPOVOLEMIC CONDITION IF THE ERROR IS NOT IDENTIFIED AND CORRECTED BY THE OPERATOR. THERE HAS BEEN NO INDICATION THAT SUCH AN EVENT DID OCCUR WITH THIS PROCEDURE. THIS ISSUE WAS IDENTIFIED DURING AN INTERNAL EVALUATION OF AVAILABLE RUN DATA FILES. NO ON-SITE SERVICE WAS PERFORMED. ONE YEAR OF SERVICE HISTORY WAS REVIEWED FOR THIS DEVICE WITH NO ISSUES RELATED TO THE REPORTED CONDITION IDENTIFIED. TERUMO BCT HAS FOLLOWED UP WITH THIS CUSTOMER TO PROVIDE FEEDBACK ON THE REPORTED CONDITION. ROOT CAUSE: THE ROOT CAUSE HAS BEEN DETERMINED TO BE A USER INTERFACE ISSUE. CORRECTION: OPTIA FIELD ACTION 24 HAS BEEN INITIATED TO CORRECT THIS ISSUE BY RELEASING A SAFETY NOTIFICATION TO ALL OPTIA USERS TO EXPRESS THE IMPORTANCE OF ENTERING THE CORRECT PATIENT DATA AND FOLLOWING THE OPERATOR'S MANUAL AND ON-SCREEN PROMPTS. CORRECTIVE ACTION: AN INTERNAL CAPA HAS BEEN INITIATED TO ADDRESS INCORRECT PATIENT DATA ENTRY. THE FIELD ACTION REFERENCED ABOVE WILL ADDRESS THIS ISSUE BY UPDATING ALL OPTIA DEVICES IN THE FIELD TO SOFTWARE VERSION 11.3. THIS SOFTWARE VERSION WILL ALLOW THE OPTIA DEVICE TO DETERMINE IF ENTERED PATIENT HEIGHT AND WEIGHT COMBINATIONS ARE FEASIBLE.

    Description of Event or Problem · 1

    AN INTERNAL INVESTIGATION WAS PERFORMED OF EVENTS IN WHICH AN OPERATOR MAY HAVE INCORRECTLY ENTERED PATIENT DATA, CREATING AN UNREASONABLE BODY MASS INDEX (BMI). THIS EVENT WAS IDENTIFIED DURING THE INTERNAL INVESTIGATION, NOT REPORTED BY THE CUSTOMER, THEREFORE PATIENT OUTCOME IS NOT AVAILABLE. DUE TO EU PERSONAL DATA PROTECTION LAWS, THE PATIENT INFORMATION IS NOT AVAILABLE FROM THE CUSTOMER. PATIENT¿S WEIGHT WAS OBTAINED FROM THE RUN DATA FILE (RDF).ENTERED WEIGHT OF PATIENT: (B)(6), ENTERED HEIGHT OF PATIENT: (B)(6), CALCULATED BMI: 111.54, ACTUAL WEIGHT OF PATIENT: (B)(6), ACTUAL HEIGHT OF PATIENT: (B)(6), BMI: 22.64. PROTOCOL PERFORMED: THERAPEUTIC PLASMA EXCHANGE.

    Description of Event or Problem · 1

    PATIENT¿S GENDER WAS OBTAINED FROM THE RUN DATA FILE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    728632 SPECTRA OPTIA SPECTRA OPTIA APHERESIS SYSTEM LKN TERUMO BCT 61000

    Patients

    Seq Age Sex Outcome Treatment
    1 Other