BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPECTRA OPTIA

    MDR report key: 3872772 · Received June 13, 2014

    Report

    Report Number
    1722028-2014-00230
    Event Type
    Death
    Date Received
    June 13, 2014
    Date of Event
    February 28, 2014
    Report Date
    May 20, 2014
    Manufacturer
    TERUMO BCT
    Product Code
    LKN
    PMA / PMN Number
    BK130065
    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: 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. ROOT CAUSE: NO FURTHER INFORMATION WAS PROVIDED BY THE CUSTOMER. BASED ON THE INFORMATION THAT WAS PROVIDED BY THE CUSTOMER, THE ROOT CAUSE OF PATIENT¿S CONDITION WAS HEMORRHAGE SECONDARY TO MOYAMOYA. NO FAILURE WAS DETECTED WITH THE DEVICE.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: PER THE CUSTOMER, THE MEDICAL DIRECTOR AT THIS PROGRAM WAS CONSULTED HE 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 RUN DATA FILE (RDF) WAS ANALYZED FOR THIS EVENT. SIGNALS IN THE RDF INDICATE THAT THE SPECTRA OPTIA SYSTEM IS SAFE 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. DURING THE PROCEDURE, THE PATIENT DEVELOPED ITCHING ON THE FACE AND NECK. DIPHENHYDRAMINE AND ACETAMINOPHEN WERE GIVEN IN RESPONSE TO THE PATIENT REACTION. AT THE COMPLETION OF THE RBCX, THE PATIENT WAS DISCHARGED HOME. PER THE CUSTOMER, APPROXIMATELY ONE WEEK LATER, THE PATIENT WAS FOUND UNCONSCIOUS AT HOME AND WAS ADMITTED THROUGH THE ER TO NEUROSURGERY SERVICE. AN MRI WAS GIVEN AND THE PATIENT WAS HOSPITALIZED IN THE ICU. PATIENT DEVELOPED A HEMORRHAGE SECONDARY TO MOYAMOYA AND EXPIRED ON (B)(6) 2014. THE DISPOSABLE SET IS NOT AVAILABLE FOR RETURN FOR EVALUATION BECAUSE THE CUSTOMER DISCARDED IT. THIS REPORT IS BEING FILED DUE TO PATIENT DEATH, THOUGH AT THIS TIME, THE DEVICE IS NOT SUSPECTED OR ALLEGED TO BE A CONTRIBUTORY FACTOR IN THE DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350163 SPECTRA OPTIA SPECTRA OPTIA EXCHANGE SET LKN TERUMO BCT 01W3119

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR