BEUDAMED
    FDA Adverse Event Other Summary report: N

    SPECTRA OPTIA

    MDR report key: 2755107 · Received September 22, 2012

    Report

    Report Number
    1722028-2012-00747
    Event Type
    Other
    Date Received
    September 22, 2012
    Date of Event
    August 10, 2012
    Report Date
    August 24, 2012
    Manufacturer
    TERUMO BCT
    Product Code
    LKN
    PMA / PMN Number
    BK080035
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION: A SERVICE CALL WAS PLACED TO DO MACHINE CHECKOUT. THE RUN DATA FILES WERE DOWNLOADED FOR INVESTIGATION. INVESTIGATION EVALUATION AND CORRECTIVE ACTIONS ARE IN-PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION: A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS UNIT SHOWED NO IRREGULARITIES DURING MANUFACTURING THAT WERE RELEVANT TO THIS ISSUE. THE RUN DATA FILES (RDF) WERE ANALYZED FOR THIS EVENT. THE RDF ANALYSIS SHOWED THAT THE DEVICE ALARMED AS DESIGNED WITH AN "AIM SYSTEM COULD NOT ESTABLISH TARGET INTERFACE" ALARMS DURING EACH RUN. THIS ALARM INSTRUCTS THE OPERATOR TO ENSURE THE SALINE LINE IS NOT CLOSED, TO CHECK THE PATIENT'S HEMATOCRIT AND POTENTIALLY ADJUST AS APPROPRIATE AND TO CHECK THAT THE CHANNEL WAS CORRECTLY LOADED. THE MACHINE WAS FUNCTIONALLY TESTED DURING THE SERVICE CALL AND NO ISSUES WERE IDENTIFIED THAT WOULD BE RELATED TO THE REPORTED CONDITION. DURING SERVICE, AN OPERATOR AT THE CLINIC STATED THE REPORTED CONDITION WAS DUE TO THE PATIENT'S CATHETER BEING MISPLACED INTO THE LUNG CAVITY, PER THE HOSPITAL'S INVESTIGATION. ROOT CAUSE: THE DEVICE OPERATED AS INTENDED AND NO ISSUES WERE IDENTIFIED WITH THE MACHINE. PER THE CUSTOMER, THE ROOT CAUSE WAS IDENTIFIED AS A MISPLACE CATHETER

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE INLET AND RETURN LINES WERE VERY DILUTE DURING TWO THERAPEUTIC PLASMA EXCHANGE (TPE) PROCEDURES ON THE SAME PATIENT. THE OPERATOR VERIFIED AT THE TIME THAT THE INLET AND RETURN SALINE LINE ROLLER CLAMPS WERE CLOSED. THE CUSTOMER REQUESTED AN INVESTIGATION OF THE RUN DATA FILES TO RULE OUT THE OPTIA EQUIPMENT AS A CAUSE OF THE EVENTS. THE HOSPITAL IS ALSO DOING AN INVESTIGATION INTO THE PATIENT'S CENTRAL VENOUS CATHETER TO SEE IF THERE IS A DEFECT THAT MIGHT HAVE CAUSED RECIRCULATION TO OCCUR. THE SECOND EVENT IS DOCUMENTED ON MDR REPORT # 1722028-2012-00743. THE INCIDENT OCCURRED AT CARTER BLOOD CARE. THE PATIENT'S HOSPITAL, (B)(6), INITIATED THE INVESTIGATION. PATIENT INFORMATION IS NOT AVAILABLE AT THIS TIME. THE DISPOSABLE SET IS NOT AVAILABLE FOR RETURN BECAUSE THE CUSTOMER DISCARDED IT. 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 1P00520

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR