BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRA OPTIA

    MDR report key: 3130273 · Received May 24, 2013

    Report

    Report Number
    1722028-2013-01219
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 29, 2013
    Manufacturer
    TERUMO BCT
    Product Code
    LKN
    PMA / PMN Number
    K103090
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION, EVALUATION AND CORRECTIVE ACTIONS ARE IN-PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: A REPORT RUN ON THE MACHINE SERIAL NUMBER SHOWS THAT THE EQUIPMENT HAS BEEN IN USE WITHOUT ANY FURTHER ISSUES. ROOT CAUSE: THE CAUSE OF THE REPORTED MIS-ENTRY OF PATIENT INFORMATION WAS OPERATOR ERROR. THE SPECTRA OPTIA MACHINE OPERATED ACCORDING TO SPECIFICATIONS. CORRECTION: A REPORT OF OPERATOR ERROR ISSUES IS DISTRIBUTED EACH QUARTER TO SALES AND IMPLEMENTATION FOR POTENTIAL TARGETED TRAINING.

    Description of Event or Problem · 1

    DURING A CUSTOMER SITE VISIT TO ADDRESS AGGREGATION ISSUES, A PROCEDURE HAD TO BE ABORTED AFTER APPROXIMATELY 30 MINUTES DUE TO A LARGE AGGREGATION IN THE RESERVOIR. IT WAS DETERMINED THAT THE CUSTOMER IS ENTERING THE SAME PATIENT INFORMATION FOR ALL PROCEDURES RUN. THE PATIENT INFO ENTERED IS HEIGHT = 190CM; WEIGHT = 90KG; GENDER = FEMALE, AND THEY EXCHANGE 7.2L OF PLASMA FOR EVERY PATIENT, WHICH COULD HAVE AN IMPACT ON PATIENT FLUID BALANCE AND ANTICOAGULANT INFUSION RATE. PATIENT INFORMATION IS NOT AVAILABLE AT THIS TIME. THIS REPORT IS BEING FILED DUE TO DEVICE MALFUNCTION, IN THE FORM OF OPERATOR ERROR, THAT HAS THE POTENTIAL FOR INJURY.

    Description of Event or Problem · 1

    ENTERING FIXED PATIENT DATA ENTRY PARAMETERS WAS A SYSTEMIC OPERATOR ERROR AT THE CUSTOMER SITE, POTENTIALLY AFFECTING MANY PROCEDURES AND PATIENTS, SO NO INDIVIDUAL PATIENT INFORMATION WAS OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232738 SPECTRA OPTIA SPECTRA OPTIA APHERESIS SYSTEM LKN TERUMO BCT 000000000000061000

    Patients

    Seq Age Sex Outcome Treatment
    1 Other