BEUDAMED
    FDA Adverse Event Death Summary report: N

    COBE SPECTRA

    MDR report key: 14803617 · Received June 24, 2022

    Report

    Report Number
    1722028-2022-00206
    Event Type
    Death
    Date Received
    June 24, 2022
    Date of Event
    March 1, 2021
    Report Date
    June 24, 2022
    Manufacturer
    TERUMO BCT
    Product Code
    LKN
    PMA / PMN Number
    BK080035
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: THE AUTHORS CONCLUDED THAT FOR THIS PARTICULAR GROUP OF MATCHED PATIENTS WITH COVID-19-INDUCED CRS, TPE+SC WAS LINKED WITH RELATIVELY BETTER OVERALL SURVIVAL, EARLY EXTUBATION, AND EARLIER DISCHARGE COMPARED TO SC ALONE. THERE IS NO EVIDENCE TO INDICATE THAT THE OPTIA DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT¿S DEATH DHR DETAILS: SINCE THIS IS A RETROSPECTIVE COHORT STUDY WHICH WAS DESIGNED PRIMARILY TO EVALUATE THE ROLE PLAYED BY THERAPEUTIC PLASMAPHERESIS USING COBE SPECTRA ON 28-DAY IN-HOSPITAL MORTALITY AMONG PATIENTS WITH SEVERE COVID-19 INFECTIONS AND CYTOKINE RELEASE SYNDROME (CRS) BETWEEN MARCH AND AUGUST, 2021, THE LOT NUMBERS WERE NOT PROVIDED; THEREFORE, A DHR SEARCH COULD NOT BE CONDUCTED FOR THIS SPECIFIC INCIDENT. ALL LOTS MUST MEET ACCEPTANCE CRITERIA FOR RELEASE. CONCLUSION: FOR THIS PARTICULAR GROUP OF MATCHED PATIENTS WITH COVID-19-INDUCED CRS, TPE+SC WAS LINKED WITH RELATIVELY BETTER OVERALL SURVIVAL, EARLY EXTUBATION, AND EARLIER DISCHARGE COMPARED TO SC ALONE. AS THESE RESULTS WERE NOT STATISTICALLY SIGNIFICANT, MULTICENTERED RANDOMIZED CONTROL TRIALS ARE NEEDED TO FURTHER ELABORATE THE ROLE OF THERAPEUTIC PLASMAPHERESIS IN COVID-19 INDUCED CRS. BASED ON TERUMOBCT INTERNAL MEDICAL REVIEW CONCLUSION, THE COBE SPECTRA DEVICE PERFORMED AS INTENDED, THERE WERE NO SUGGESTED DEVICE FAILURES, MALFUNCTIONS, MISLABELING, IMPROPER OR INADEQUATE DESIGN OR MANUFACTURING ERRORS, NOR WAS THERE ANY REPORTED USER ERRORS THAT CONTRIBUTED TO OR CAUSED THESE ADVERSE EVENTS. ROOT CAUSE: A ROOT CAUSE ASSESSMENT WAS PERFORMED FOR THIS COMPLAINT. BASED ON THE AVAILABLE INFORMATION A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. IT IS LIKELY THAT THE PATIENT DIED AS A RESULT OF COVID AND/OR COMORBIDITIES. JOURNAL ARTICLE: JAMIL, ET AL.: ROLE OF THERAPEUTIC PLASMAPHERESIS IN SARS-COV-2 INDUCED CYTOKINE RELEASE SYNDROME: A RETROSPECTIVE COHORT STUDY ON COVID-19 PATIENTS. INTERNATIONAL JOURNAL OF GENERAL MEDICINE 2022:15 4907¿4916.

    Description of Event or Problem · 0

    THE ARTICLE, 'ROLE OF THERAPEUTIC PLASMAPHERESIS IN SARS-COV-2 INDUCED CYTOKINE RELEASE SYNDROME: A RETROSPECTIVE COHORT STUDY ON COVID-19 PATIENTS', DESCRIBES A RETROSPECTIVE COHORT STUDY WHICH WAS DESIGNED PRIMARILY TO EVALUATE THE ROLE PLAYED BY THERAPEUTIC PLASMAPHERESIS USING COBE SPECTRA ON 28-DAY IN-HOSPITAL MORTALITY AMONG PATIENTS WITH SEVERE COVID-19 INFECTIONS AND CYTOKINE RELEASE SYNDROME (CRS) BETWEEN MARCH AND AUGUST, 2021. THE EFFECT OF PLASMAPHERESIS ON INFLAMMATORY MARKERS, THE NEED FOR MECHANICAL VENTILATION, THE RATE OF EXTUBATION AND SURVIVAL DURATION WERE STUDIED AS SECONDARY OUTCOMES. ALL EXCEPT 3 PATIENTS UNDERWENT 5 SESSIONS OF PLASMAPHERESIS; 2 PATIENTS SHOWED NOTABLE CLINICAL AND BIOCHEMICAL IMPROVEMENT AFTER 3 SESSIONS, 1 PATIENT DIED AFTER TWO SESSIONS. THE AUTHORS DID NOT SPECIFY THE TIME OF DEATH IN RELATION TO THE TPE PROCEDURE. THIS REPORT IS BEING FILED DUE TO PATIENT DEATH, ALTHOUGH PER CURRENT INFORMATION THERE IS NO DETECTABLE MALFUNCTION WITH THE TERUMO BCT DEVICE OR ALLEGATION OF A MALFUNCTION. THIS IS A RETROSPECTIVE COHORT STUDY WHICH WAS DESIGNED PRIMARILY TO EVALUATE THE ROLE PLAYED BY THERAPEUTIC PLASMAPHERESIS USING COBE SPECTRA ON 28-DAY IN-HOSPITAL MORTALITY AMONG PATIENTS WITH SEVERE COVID-19 INFECTIONS AND CYTOKINE RELEASE SYNDROME (CRS) BETWEEN MARCH AND AUGUST, 2021. A REQUEST FOR SPECIFIC DONOR INFORMATION IS NOT FEASIBLE. THE DEVICE IS NOT AVAILABLE FOR RETURN FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    770685 COBE SPECTRA COBE SPECTRA TPE SET LKN TERUMO BCT

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other