BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA OPTIA

    MDR report key: 5132192 · Received October 7, 2015

    Report

    Report Number
    1722028-2015-00572
    Event Type
    Injury
    Date Received
    October 7, 2015
    Date of Event
    September 11, 2015
    Report Date
    September 11, 2015
    Manufacturer
    TERUMO BCT
    Product Code
    LKN
    PMA / PMN Number
    BK140191
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: ACCORDING TO THE THERAPEUTIC APHERESIS: A PHYSICIAN'S HANDBOOK, IT NOTES THAT WITHIN A SINGLE-CENTER US STUDY, 36% OF PROCEDURES INVOLVED SOME SORT OF COMPLICATION. THE NUMBER OF COMPLICATIONS AND RATE OF COMPLICATIONS WERE SIGNIFICANTLY GREATER INPATIENTS RECEIVING PLASMA AS THE REPLACEMENT FLUID RATHER THAN ALBUMIN. THE STUDY ALSO NOTES THAT MOST COMPLICATIONS WERE MINOR AND WELL TOLERATED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: THE CUSTOMER STATED THAT DURING THE PROCEDURE, THE REPLACEMENT FLUID WAS SWITCHED FROM ALBUMIN TO FRESH FROZEN PLASMA (FFP). THE REACTION OCCURRED WITHIN 19 MINUTES OF SWITCHING TO THE FFP. THE RUN DATA FILE (RDF) WAS ANALYZED FOR THIS EVENT. BASED ON THE RDF ANALYSIS, THERE WERE NO ISSUES WITH THE SPECTRA OPTIA AND THE SYSTEM OPERATED AS INTENDED. INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Additional Manufacturer Narrative · 1

    A TERUMO BCT SERVICE TECHNICIAN VISUALLY INSPECTED THE DEVICE AT THE CUSTOMER SITE. AN AUTO TEST AND SALINE RUN WAS SUCCESSFULLY PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THIS UNIT SHOWED NO IRREGULARITIES DURING MANUFACTURING THAT WERE RELEVANT TO THIS ISSUE. ROOT CAUSE: BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER, THE MACHINE INSPECTION, AND THE RUN DATA FILE CONCLUSION, THE PATIENT¿S FEELING OF A TIGHT CHEST WAS CAUSED BY AN ALLERGIC REACTION TO THE FRESH FROZEN PLASMA. THE SPECTRA OPTIA SYSTEM HAS MANY SAFETY FEATURES. HOWEVER, A PATIENT REACTION CAN OCCUR RAPIDLY. THEREFORE, AS NOTED IN THE SPECTRA OPTIA ESSENTIALS GUIDE, IT IS IMPERATIVE THAT THE OPERATOR MONITOR THE PATIENT AND THE SYSTEM THROUGHOUT THE PROCEDURE. THE BLOOD BANK AND THE PHYSICIAN SUSPECT THE PATIENT¿S ALLERGIC REACTION WAS DUE TO THE FRESH FROZEN PLASMA (FFP)BEING ADMINISTERED AT THE TIME.

    Additional Manufacturer Narrative · 1

    THIS RECORD WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF MDR'S, PER FDA REQUEST, TO IDENTIFY RECORDS IN WHICH A SERIOUS INJURY OR MEDICAL INTERVENTION OCCURRED, BUT THE TYPE OF REPORTABLE EVENT WAS NOT INDICATED AS A SERIOUS INJURY OF THE MDR FORM. THIS SUPPLEMENT IS BEING FILED TO MODIFY INFORMATION PER FDA REQUEST.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A PEDIATRIC PATIENT HAD AN ALLERGIC REACTION TO THE FRESH FROZEN PLASMA (FFP) BEING USED DURING A THERAPEUTIC PLASMA EXCHANGE (TPE) PROCEDURE. APPROXIMATELY 2/3 INTO THE PROCEDURE, PATIENT DEVELOPED ITCHING, HIVES, AND CHEST TIGHTNESS. PER NEPHROLOGIST'S ORDERS, 50MG BENADRYL, 60MG DECADRON WAS GIVEN TO THE PATIENT VIA IV ANDRACEMIC EPI INHALENT WAS ADMINISTERED ORALLY. NO MEDICAL CODE WAS CALLED. THE PATIENT WAS TRANSFERRED TO THE RENAL UNIT FOR OBSERVATION OVERNIGHT. THE PATIENT WAS DISCHARGED FROM THE RENAL UNIT IN STABLE CONDITION. THE CUSTOMER DECLINED TO PROVIDE PATIENT IDENTIFIER. THE DISPOSABLE KIT IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663877 SPECTRA OPTIA SPECTRA OPTIA EXCHANGE SET LKN TERUMO BCT 07Y3122

    Patients

    Seq Age Sex Outcome Treatment
    1 00012 YR Hospitalization| O