BEUDAMED
    FDA Adverse Event Summary report: N

    SPECTRA OPTIA

    MDR report key: 2771026 · Received October 3, 2012

    Report

    Report Number
    1722028-2012-00780
    Date Received
    October 3, 2012
    Date of Event
    August 28, 2012
    Report Date
    September 6, 2012
    Manufacturer
    TERUMO BCT
    Product Code
    LKN
    PMA / PMN Number
    BK080035
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION EVALUATION AND CORRECTIVE ACTIONS ARE IN-PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION: THE MACHINE WAS EVALUATED BY THE SERVICE TECHNICIAN AND NO ISSUES WERE FOUND. A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS UNIT SHOWED NO IRREGULARITIES DURING MANUFACTURING THAT WERE RELEVANT TO THIS ISSUE. ROOT CAUSE: UNDETERMINED. POTENTIAL CAUSES OF A FLUID IMBALANCE INCLUDE INCORRECTLY LOADED TUBING SET, INCORRECTLY ENTERED PATIENT INFORMATION, A DEFECTIVE PUMP, AND PUMP ROTOR OCCLUSION ISSUES. THE MACHINE WAS RETURNED TO SERVICE AFTER NO ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    (B)(4). THE MACHINE HAS BEEN IN CONTINUED USE, COMPLETING A NUMBER OF PROCEDURES WITHOUT PROBLEMS SINCE THE REPORTED INCIDENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FLUID BALANCE ISSUE ON A RED BLOOD CELL EXCHANGE PROCEDURE. PATIENT INFORMATION IS NOT AVAILABLE AT THIS TIME. THIS REPORT IS BEING FILED DUE TO INSUFFICIENT INFORMATION PROVIDED AT THIS TIME TO DETERMINE IF A MALFUNCTION WITH THE POTENTIAL FOR DEATH OR INJURY OCCURRED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR