BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPECTRA OPTIA

    MDR report key: 3872694 · Received June 13, 2014

    Report

    Report Number
    1722028-2014-00229
    Event Type
    Death
    Date Received
    June 13, 2014
    Date of Event
    May 8, 2014
    Report Date
    May 20, 2014
    Manufacturer
    TERUMO BCT
    Product Code
    LKN
    PMA / PMN Number
    BK120076
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS RECORD WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF MDRS TO IDENTIFY RECORDS IN WHICH AN EVENT OCCURRED, BUT THE TYPE OF REPORTABLE EVENT WAS NOT INDICATED APPROPRIATELY IN THE MDR FORM. THIS SUPPLEMENT IS BEING FILED TO MODIFY INFORMATION TO ALIGN WITH THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: PER THE CUSTOMER, THE MEDICAL DIRECTOR AT THIS PROGRAM WAS CONSULTED AND STATED THE DEATH HAD NOTHING TO DO WITH THE DEVICE. HE STATED THAT THE PATIENT WAS VERY OLD FOR A SICKLE CELL PATIENT AND THEY ARE LEARNING WHAT OTHER COMPLICATIONS PRESENT AT THAT AGE FOR A SICKLE CELL PATIENT. INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: THE DISPOSABLE SET WAS UNAVAILABLE FOR RETURN AND INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THIS UNIT SHOWED NO IRREGULARITIES DURING MANUFACTURING THAT WERE RELEVANT TO THIS ISSUE. A REVIEW OF THE LOT FOR SIMILAR REPORTS WAS CARRIED OUT AND NONE HAVE BEEN REPORTED. MULTIPLE ATTEMPTS TO OBTAIN THE DISCHARGE SUMMARY AND AUTOPSY REPORT OF THE PATIENT WERE UNANSWERED BY THE CUSTOMER. ROOT CAUSE: THE ROOT CAUSE REMAINS UNDETERMINED AT THIS TIME DUE TO LIMITED INFORMATION OBTAINED. NO FAILURE OF THE DEVICE WAS DETECTED IN THE RDFS OR DHR. PER THE MEDICAL DIRECTOR, THE DEATH WAS UNRELATED TO THE RBCX PROCEDURE.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: THE RUN DATA FILE (RDF) WAS ANALYZED FOR THIS EVENT. THE SIGNALS IN THE RUN DATA FILE INDICATE THAT THE SPECTRA OPTIA SYSTEM IS SAFE TO USE AND OPERATED AS INTENDED. INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A PATIENT UNDERWENT A RED BLOOD CELL EXCHANGE (RBCX) PROCEDURE. THE PATIENT WAS DISCHARGED AFTER THE COMPLETION OF THE PROCEDURE ON (B)(6) 2014. APPROXIMATELY 24 HOURS AFTER THE DISCHARGE, THE PATIENT SUFFERED A STROKE AND HEAD BLEED. THE PATIENT WAS TAKEN TO THE EMERGENCY ROOM AND ADMITTED TO THE HOSPITAL. THE PATIENT EXPIRED ON (B)(6) 2014. THE DISPOSABLE KIT IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER. THIS REPORT IS BEING FILED DUE TO PATIENT DEATH, THOUGH AT THIS TIME IT IS NOT BELIEVED THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349576 SPECTRA OPTIA SPECTRA OPTIA EXCHANGE SET LKN TERUMO BCT 03V3221

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR ACETAMINOPHEN(325MG)DIPHENHYDRAMINE(25MG) 2014