BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPECTRA OPTIA

    MDR report key: 7075330 · Received December 1, 2017

    Report

    Report Number
    1722028-2017-00460
    Event Type
    Death
    Date Received
    December 1, 2017
    Date of Event
    November 4, 2017
    Report Date
    December 1, 2017
    Manufacturer
    TERUMO BCT
    Product Code
    LKN
    PMA / PMN Number
    K153601
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: PER THE CUSTOMER, THE PATIENT HAD RECEIVED 5 TPE PROCEDURES PRIOR TO THISEVENT AND DESPITE THE DNR IT WAS DECIDED TO PERFORM ANOTHER TREATMENT AS THE PATIENT'S PLATELET COUNT WAS RESPONDING TO THE TREATMENT.THE CUSTOMER DID NOT PROVIDE THE LOT NUMBER PERTAINING TO THIS EVENT, THEREFOREA DEVICE HISTORY RECORD (DHR) SEARCH COULD NOT BE CONDUCTED FOR THIS SPECIFIC INCIDENT. ALL LOTSMUST MEET ACCEPTANCE CRITERIA BEFORE RELEASE.A SERVICE CALL WAS PLACED AND A FULL MACHINE CHECKOUT WAS PERFORMED. THE MACHINE IS FUNCTIONINGPER MANUFACTURERS SPECIFICATION. AN AUTO TEST AND SALINE RUN WAS SUCCESSFULLY PERFORMED.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:THE RUN DATA FILE (RDF) WAS ANALYZED FOR THIS EVENT. THE SIGNALS IN THE RDF INDICATED THAT THE SPECTRA OPTIA SYSTEM OPERATED AS INTENDED. PER TERUMO BCT'S MEDICAL REVIEW, THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THIS INCIDENT. ROOT CAUSE: ACCORDING TO THE INFORMATION PROVIDED BY THE HOSPITAL, THE PATIENT¿S DEATH IS UNRELATED TO THE TERUMO BCT DEVICE. THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT¿S DEATH. THE AUTOPSY IS UNAVAILABLE. HOWEVER, EVIDENCE SUCH AS THE CRITICAL CONDITION OF THE PATIENT INDICATES THAT A POSSIBLE CAUSE OF DEATH IS RELATED TO THE PATIENT DISEASE STATE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED APPROXIMATELY 93 MINUTES INTO A THERAPUTIC PLASMA EXCHANGE (TPE)PROCEDURE,THE PATIENT'S OXYGEN SATURATION LEVELS WERE DROPPING. PER PHYSICIAN'S ORDER,THEPROCEDURE WAS ENDED WITH RINSEBACK. APPROXIMATELY 30 MINUTES POST PROCEDURE THE PATIENT EXPIRED. PER THE CUSTOMER, THE PATIENT WAS IN CRITICAL CONDITION PRIOR TO THE PROCEDURE ANDAUTOPSY WAS NOT REQUESTED AS PATIENT'S FAMILY REQUESTED DNR (DO NOT RESUSCITATE) ON (B)(6) 2017.THE CUSTOMER DECLINED TO PROVIDE PATIENT IDENTIFIER.THE TPE COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED DUE TO PATIENT DEATH, ALTHOUGH PER CURRENT INFORMATION THERE IS NO SUSPECTED MALFUNCTION WITH THE TERUMO BCT DEVICE OR ALLEGATION OF A MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    855620 SPECTRA OPTIA SPECTRA OPTIA EXCHANGE SET LKN TERUMO BCT

    Patients

    Seq Age Sex Outcome Treatment
    1 00083 YR Other