BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPECTRA OPTIA

    MDR report key: 9796558 · Received March 6, 2020

    Report

    Report Number
    1722028-2020-00090
    Event Type
    Death
    Date Received
    March 6, 2020
    Date of Event
    February 8, 2020
    Report Date
    March 5, 2020
    Manufacturer
    TERUMO BCT
    Product Code
    LKN
    PMA / PMN Number
    K183081
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: PER THE CUSTOMER, AUTOPSY RESULTS ARE NOT AVAILABLE. THE EQUIPMENT WAS CHECKED OUT BY TERUMO BCT TECHNICIAN. A VISUAL INSPECTION WAS PERFORMED AND NO PROBLEMS FOUND. A COMPLETE SIMULATED SALINE RUN WITH A TPE SET WAS PERFORMED WITH NO PROBLEMS WITH THE RUN OR THE EQUIPMENT. THERE IS NO PROBLEM FOUND WITH THE EQUIPMENT. EQUIPMENT HAS BEEN CHECKED OUT AND IS READY TO BE PLACED BACK INTO SERVICE. INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED TO PROVIDE ADDITIONAL INFORMATION. INVESTIGATION: DURING FOLLOW-UP WITH THE CUSTOMER, IT WAS REPORTED THAT THE AUTOPSY RESULTS ARE NOT AVAILABLE. INVESTIGATION IS IN PROCESS, A FOLLOW-UP REPORT WILL BE PROVIDED.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED TO PROVIDE ADDITIONAL INFORMATION. UPDATED INVESTIGATION: DEVICE SERVICE WAS PERFORMED ON 17TH FEBRUARY 2020. VISUAL INSPECTION FOUND NO DAMAGE AND ALL GROUNDING WAS SECURED AND RESISTANCE WAS NORMAL. A PRESSURE CHECK ON ALL PRESSURE TRANSDUCERS CONFIRMED ALL WERE 100% FUNCTIONAL AND WITHIN MANUFACTURER SPECIFICATIONS. A LEAKAGE CURRENT TEST AND AN AUTOTEST WERE COMPLETED. ALL TESTS PASSED. THE DEVICE WAS VERIFIED TO BE OPERATING PER MANUFACTURER SPECIFICATIONS. ROOT CAUSE: BASED ON THE CUSTOMER'S STATEMENTS, SUPPORTED BY THE CLINICAL FINDINGS, RDF ANALYSIS, AND THE SERVICE PERFORMED ON THE DEVICE, THE CAUSE OF THE PATIENT'S DEATH WAS LIKELY DUE TO THE PATIENT'S MEDICAL CONDITION.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: A DISPOSABLE COMPLAINT HISTORY SEARCH FOR LOT 1912123230 FOUND NO OTHER REPORTS OF A SIMILAR FAILURE. THE RUN DATA FILES WERE REVIEWED FOR THIS EVENT. FROM THE FILES, THE PUMPS AND SENSORS PERFORMED ACCORDING TO SPECIFICATION. THERE WERE NO ABNORMAL ALARMS THAT WOULD HAVE BEEN DETRIMENTAL TO THE PROCEDURE OR THE PATIENT. PRESSURES AND LEVELS IN THE SET WERE WITHIN THE NORMAL OPERATING RANGES. THE DEVICE PERFORMED ACCORDING TO OUR DESIGN AND SPECIFICATIONS. PER INTERNAL MEDICAL REVIEW AND ANALYSIS, THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THIS INCIDENT. INVESTIGATION IS IN PROCESS. A FOLLOW UP REPORT WILL BE PROVIDED.

    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. INVESTIGATION IS IN PROCESS. A FOLLOW UP REPORT WILL BE PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ABOUT 7 MINUTES INTO THE THERAPEUTIC PLASMA EXCHANGE (TPE) PROCEDURE, THE PATIENT'S TEMPERATURE STARTED TO DROP AND THEN THE BLOOD PRESSURE. THEY STOPPED THE PROCEDURE AND STARTED TO CODE THE PATIENT. THE PATIENT THEN EXPIRED. THE CUSTOMER DOES NOT SUSPECT THE DEVICE CAUSED THE EVENT. THE DISPOSABLE SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER. THIS REPORT IS BEING FILED DUE THE PATIENT DEATH, HOWEVER, IT IS NOT ALLEGED OR SUSPECTED THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT DEATH.

    Description of Event or Problem · 1

    PATIENT ID IS NOT AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    UPON FOLLOW-UP, THE CUSTOMER DECLINED TO COMMENT ABOUT OR PROVIDE INFORMATION PERTAINING TO THE CAUSE OF DEATH. THE CUSTOMER DID NOT SUSPECT A DEVICE MALFUNCTION (DISPOSABLE SET/NEEDLE/EQUIPMENT) CAUSED THE DEATH. THE CUSTOMER DECLINED TO PROVIDE THE PATIENT IDENTIFIER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260251 SPECTRA OPTIA SPECTRA OPTIA EXCHANGE SET LKN TERUMO BCT 1912123230

    Patients

    Seq Age Sex Outcome Treatment
    1 00015 YR Other