BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRA OPTIA

    MDR report key: 6180969 · Received December 16, 2016

    Report

    Report Number
    1722028-2016-00647
    Event Type
    Malfunction
    Date Received
    December 16, 2016
    Date of Event
    February 15, 2016
    Report Date
    December 16, 2016
    Manufacturer
    TERUMO BCT
    Product Code
    LKN
    PMA / PMN Number
    K113480
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: 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-SITES SERVICE WAS PERFORMED. ONE YEAR OF SERVICE HISTORY WAS REVIEWED FOR THIS DEVICE WITH NO ISSUES RELATED TO THE REPORTED CONDITION IDENTIFIED. 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. 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. THE OPTIA DEVICE AT THE CUSTOMER'S SITE WAS UPDATED TO THE NEW SOFTWARE VERSION 11.3. CORRECTIVE ACTION: AN INTERNAL CAPA HAS BEEN INITIATED TO ADDRESS INCORRECT PATIENT DATA ENTRY.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DUE TO EU PERSONAL DATA PROTECTION LAWS, THE PATIENT INFORMATION IS NOT AVAILABLE FROM THE CUSTOMER. DONOR GENDER AND WEIGHT WERE OBTAINED FROM THE RUN FILES.

    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. PATIENT INFORMATION IS NOT AVAILABLE AT THIS TIME. ENTERED WEIGHT OF PATIENT: 163 KG ENTERED HEIGHT OF PATIENT: 58 CM CALCULATED BMI: 484.54 PROTOCOL PERFORMED: WHITE BLOOD CELL COLLECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    833670 SPECTRA OPTIA SPECTRA OPTIA APHERESIS SYSTEM LKN TERUMO BCT 61000

    Patients

    Seq Age Sex Outcome Treatment
    1 Other