BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA OPTIA

    MDR report key: 5997387 · Received October 4, 2016

    Report

    Report Number
    1722028-2016-00539
    Event Type
    Injury
    Date Received
    October 4, 2016
    Date of Event
    September 5, 2016
    Report Date
    October 4, 2016
    Manufacturer
    TERUMO BCT
    Product Code
    LKN
    PMA / PMN Number
    K153601
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED TO PROVIDE ADDITIONAL INFORMATION. ADDITIONAL INVESTIGATION: PER TERUMO BCT'S MEDICAL REVIEW, THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THIS INCIDENT.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THIS UNIT SHOWED NO IRREGULARITIES DURING MANUFACTURING THAT WERE RELEVANT TO THIS ISSUE. PER TERUMO BCT'S INTERNAL DOCUMENTATION, THE DEVICES TERUMO BCT MANUFACTURES TO COLLECT, SEPARATE, AND STORE BLOOD PRODUCTS ARE TERMINALLY STERILIZED TO A STERILITY ASSURANCE LEVEL (SAL) OF</=10-6. ADDITIONALLY, A STERILITY ASSURANCE SYSTEM HAS BEEN DESIGNED AND EMPLOYED TO ENSURE THIS SAL WILL BE ACHIEVED FOR EVERY LOT OF PRODUCT MANUFACTURED. THE STERILITY ASSURANCE SYSTEM EMPLOYED AT TERUMO BCT ENSURES THE DISPOSABLE DEVICE IS NOT THE SOURCE OF CONTAMINATION. ROOT CAUSE: NO SYSTEM-RELATED ROOT CAUSE FOR THE ALLEGED BACTERIAL CONTAMINATION WAS IDENTIFIED IN THE RUN DATA FILES FOR THE PROCEDURE. THERE WERE NO LEAK ALARMS OR CENTRIFUGE STOPS DURING THESE PROCEDURES TO SUGGEST THE DISPOSABLE SET BECAME AN OPEN SET AT ANY POINT IN THE PROCEDURE. REVIEW OF THE IMAGES SHOWS NO ABNORMAL BEHAVIOR OR FOREIGN MATTER IN THE CONNECTOR AND SIGNALS IN THE DLOG INDICATE THE SETS WERE LOADED AND PRIMED WITHIN THE ONE-WORKING SHIFT RECOMMENDATION PROVIDED IN THE SPECTRA OPTIA ESSENTIALS GUIDE. CONSEQUENTLY, THE SYSTEM WAS FOUND TO BE OPERATING AS INTENDED DURING THESE PROCEDURES. ADDITIONALLY, THE STERILITY ASSURANCE SYSTEM EMPLOYED AT TERUMO BCT ENSURES THE DEVICE IS NOT THE SOURCE OF CONTAMINATION. SOURCES OF BACTERIAL CONTAMINATION UNRELATED TO THE SPECTRA OPTIA SYSTEM MAY INCLUDE, BUT ARE NOT LIMITED TO:- PATIENT/DONOR CONNECTION TO THE DISPOSABLE SET- POST-PROCESSING LABORATORY PRACTICES.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: THE RUN DATA FILE (RDF) WAS ANALYZED FOR THIS EVENT. NO SYSTEM-RELATED ROOT CAUSE FOR THE ALLEGED BACTERIAL CONTAMINATION WAS IDENTIFIED. REVIEW OF THE INTERFACE MANAGEMENT IMAGES SHOWED NO ABNORMAL BEHAVIOR OR FOREIGN MATTER IN THE CONNECTOR AND SIGNALS IN THE RDF INDICATE THE SET WAS LOADED AND PRIMED WITHIN THE ONE-WORKING SHIFT RECOMMENDATION PROVIDED IN THE SPECTRA OPTIA ESSENTIALS GUIDE. 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'S INFORMATION AND OUTCOME ARE NOT AVAILABLE FROM THE CUSTOMER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED MICROBIAL CONTAMINATION OF A PRODUCT COLLECTED ON AN OPTIA SET. AT INITIAL MICROBIAL TESTING, THE PRODUCT WAS NEGATIVE, BUT AFTER 5 DAYS OF INCUBATION, THE PRODUCT HAD A POSITIVE TEST FOR GRAM-NEGATIVE STICK. THE UNIT IS PLANNED TO BE TRANSFUSED TO THE PATIENT. PROPHYLACTIC ANTIBIOTICS ARE PLANNED FOR THE TRANSFUSION RECIPIENT. PATIENT INFORMATION AND OUTCOME ARE NOT AVAILABLE AT THIS TIME. GENDER AND WEIGHT IN REPORT ARE FOR THE DONOR. THE SPECTRA OPTIA COLLECT SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    648292 SPECTRA OPTIA SPECTRA OPTIA IDL SET LKN TERUMO BCT 05Z3325

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R