BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPECTRA OPTIA

    MDR report key: 10038942 · Received May 8, 2020

    Report

    Report Number
    1722028-2020-00217
    Event Type
    Death
    Date Received
    May 8, 2020
    Date of Event
    January 1, 2016
    Report Date
    May 8, 2020
    Manufacturer
    TERUMO BCT
    Product Code
    LKN
    PMA / PMN Number
    K183081
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED TO PROVIDE ADITIONAL INFORMATION IN B.5, H.6 AND H.10. INVESTIGATION: THERE IS NO EVIDENCE TO INDICATE THAT THE SPECTRA OPTIA DEVICE CAUSED OR CONTRIBUTED TO THE DEATH OF THE PATIENT. SINCE THIS WAS A RETROSPECTIVE STUDY TO EVALUATE 40 PATIENTS WITH AN AGE RANGE OF 3-15 YEARS ADMITTED TO A TERTIARY CARE TEACHING HOSPITAL, FROM (B)(6)2013 TO (B)(6) 2014, REFERRED FOR TPE, THE LOT NUMBERS ARE UNKNOWN; THEREFORE, DHR SEARCHES COULD NOT BE CONDUCTED FOR THE REPORTED INCIDENTS. ALL LOTS MUST MEET ACCEPTANCE CRITERIA FOR RELEASE. PER INTERNAL MEDICAL REVIEW AND ANALYSIS, THE SPECTRA OPTIA 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 THE REPORTED DEATH. ROOT CAUSE: A DEFINITIVE ROOT CAUSE FOR THE PATIENT DEATH COULD NOT BE DETERMINED BUT IS LIKELY RELATED TO PRE-EXISTING DISEASE STATE.

    Description of Event or Problem · 0

    THIS WAS A RETROSPECTIVE STUDY TO EVALUATE 40 PATIENTS, BOTH MALE AND FEMALE, WITH AN AGE RANGE OF 3-15 YEARS ADMITTED TO A TERTIARY CARE TEACHING HOSPITAL, FROM (B)(6) 2013 TO (B)(6) 2014, REFERRED FOR TPE. A REQUEST FOR SPECIFIC PATIENT INFORMATION IS NOT FEASIBLE.

    Additional Manufacturer Narrative · 1

    LOT NUMBER AND EXPIRY ARE NOT AVAILABLE AT THIS TIME. ARTICLE CITATION: GAJJAR, M, ET AL. 2016. THERAPEUTIC PLASMA EXCHANGE IN PEDIATRIC PATIENTS OF GUILLAIN¿BARRE SYNDROME: EXPERIENCE FROM A TERTIARY CARE CENTRE. ASIAN JOURNAL OF TRANSFUSION SCIENCE. 2016 JAN-JUN; 10(1): 98¿100. INVESTIGATION IS IN PROCESS. A FOLLOW UP REPORT WILL BE PROVIDED.

    Description of Event or Problem · 1

    THE ARTICLE, 'THERAPEUTIC PLASMA EXCHANGE IN PEDIATRIC PATIENTS OF GUILLAIN¿BARRE SYNDROME: EXPERIENCE FROM A TERTIARY CARE CENTRE' (GAJJAR 2016) DESCRIBES 40 PEDIATRIC PATIENTS WHO UNDERWENT 122 THERAPEUTIC PLASMA EXCHANGE (TPE) PROCEDURES FOR TREATMENT OF GUILLAN-BARRE SYNDROME (GBS). ALL PATIENTS WERE TREATED WITH SPECTRA OPTIA. PATIENTS WERE BETWEEN 3 TO 15 YEARS OF AGE. TPE PROCEDURES WERE PERFORMED ON ALTERNATE DAYS DEPENDING ON THE CLINICAL CONDITION OF THE PATIENT. PATIENT'S TOTAL BLOOD VOLUME WAS CALCULATED AS PER NADLER'S FORMULA AND PROCESSED THROUGH CENTRAL DOUBLE LUMEN CATHETER. 1-1.5 PLASMA VOLUME WAS EXCHANGED WITH NORMAL SALINE AND FRESH FROZEN PLASMA. MORE THAN THREE TPE PROCEDURES WERE PERFORMED IN 29 PATIENTS, OF WHICH 27 PATIENTS SHOWED IMPROVEMENT FROM GRADE-0 AND GRADE-I TO GRADE-III. ONE DID NOT SHOW ANY RESPONSE AND SUCCUMBED TO THE DISEASE. SPECIFIC DETAILS REGARDING THE PATIENT DEATH, SUCH AS PATIENT INFORMATION, WERE NOT INCLUDED IN THE ARTICLE. 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 THE DISPOSABLE SETS ARE NOT AVAILABLE FOR RETURN BECAUSE THEY WERE DISCARDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504355 SPECTRA OPTIA SPECTRA OPTIA EXCHANGE SET LKN TERUMO BCT

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other