BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA OPTIA

    MDR report key: 21595585 · Received March 13, 2025

    Report

    Report Number
    1722028-2025-00057
    Event Type
    Injury
    Date Received
    March 13, 2025
    Date of Event
    November 1, 2024
    Report Date
    March 13, 2025
    Manufacturer
    TERUMO BCT
    Product Code
    LKN
    UDI-DI
    05020583102200
    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

    INVESTIGATION: LOT NUMBER, MANUFACTURING AND EXPIRY DATE ARE NOT AVAILABLE AT THIS TIME. INVESTIGATION IS IN PROCESS, A FOLLOW-UP REPORT WILL BE PROVIDED. CITATION: U.B DAVOOD, PANDEEP KAUR, AKARSHAN GUPTA, ANUNEET TRIPATHI, AMIT KUMAR CHATTERJEE, AMIT KUMAR, ANKITA NIGAM, SHOBNA BHATIA, HEPATITIS A AND LEPTOSPIROSIS DUAL INFECTION-INDUCED FULMINANT HEPATIC FAILURE SUCCESSFULLY TREATED WITH STANDARD VOLUME THERAPEUTIC PLASMA EXCHANGE, TRANSFUSION CLINIQUE ET BIOLOGIQUE, VOLUME 31, ISSUE 4, 2024, PAGES 265-266, ISSN 1246-7820, HTTPS://DOI.ORG/10.1016/J.TRACLI.2024.06.005 (HTTPS://WWW.SCIENCEDIRECT.COM/SCIENCE/ARTICLE/PII/S1246782024000673).

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED TO PROVIDE ADDITIONAL INFORMATION IN B.5, H.6 AND H.11. INVESTIGATION: LOT NUMBER, MANUFACTURING AND EXPIRY DATE ARE NOT AVAILABLE AT THIS TIME. THERAPEUTIC PLASMA EXCHANGE (TPE) IS COMMONLY EMPLOYED AS A BRIDGE THERAPY TO LIVER TRANSPLANTATION OR SPONTANEOUS RECOVERY BY REMOVING AMMONIA, AND INFLAMMATORY MEDIATORS WHILE RESTORING HEMOSTASIS. ACCORDING TO AMERICAN SOCIETY FOR APHERESIS (ASFA) GUIDELINES, ALF IS A CATEGORY I INDICATION (FIRST LINE TREATMENT OPTION) FOR HIGH-VOLUME TPE (HV-TPE) AND A CATEGORY III INDICATION (OPTIMUM ROLE OF TPE NOT ESTABLISHED) FOR STANDARD VOLUME TPE (SV-TPE). THE PATIENT PRESENTED WITH COMPLAINTS OF FEVER, JAUNDICE FOR 7 DAYS AND DECREASED URINE OUTPUT, ALTERED SENSORIUM FOR ONE DAY. LABORATORY INVESTIGATIONS REVEALED ELEVATED LIVER ENZYMES, BILIRUBIN, WHITE BLOOD CELL COUNT, AND SERUM AMMONIA. (TABLE 1) POSITIVE HEPATITIS A AND LEPTOSPIRA IGM ANTIBODIES CONFIRMED A DUAL INFECTION. GIVEN THE SEVERITY, THE PATIENT WAS INTUBATED, RECEIVED SUPPORTIVE CARE, AND UNDERWENT SV-TPE. SV-TPE WAS INITIATED ON THE THIRD DAY OF ADMISSION FOLLOWING THE INSERTION OF A DOUBLE-LUMEN HEMODIALYSIS CATHETER IN THE RIGHT INTERNAL JUGULAR VEIN (IJV). OVER THREE DAYS, 1.3, 1.5, AND 1.5 TIMES THE PATIENT PLASMA VOLUME WERE EXCHANGED USING THE SPECTRA OPTIA APHERESIS SYSTEM WITH FRESH FROZEN PLASMA AND NORMAL SALINE AS REPLACEMENT FLUIDS. IONIZED CALCIUM LEVELS WERE MONITORED, AND CALCIUM GLUCONATE WAS INFUSED PROPHYLACTICALLY THROUGHOUT THE PROCEDURE IN VIEW OF POTENTIAL HYPOCALCEMIA. IMMEDIATELY AFTER THE FIRST PROCEDURE, THE PATIENT DEVELOPED HYPOTENSION NECESSITATING INTRAVENOUS FLUIDS AND NORADRENALINE. THE SECOND AND THIRD PROCEDURES WERE CONDUCTED WITH A SLIGHTLY POSITIVE FLUID BALANCE AS A PRECAUTIONARY MEASURE TO ADDRESS THE HYPOTENSION AND BOTH PROCEDURES WERE UNEVENTFUL. A TRANSTHORACIC SUBCOSTAL ECHOCARDIOGRAPHY WAS USED TO MONITOR INFERIOR VENA CAVA (IVC) DIAMETER POST-PROCEDURE AND ASSESS THE VOLUME STATUS. RIGHT AFTER THE PROCEDURE, A DRASTIC REDUCTION IN BILIRUBIN LEVELS WAS OBSERVED, FOLLOWED BY A REBOUND INCREASE DUE TO BILIRUBIN ENTERING FROM EXTRAVASCULAR SPACES. DESPITE THIS FLUCTUATION, OTHER LIVER FUNCTION AND COAGULATION PARAMETERS REMAINED STABLE ONCE TPE STARTED. BY THE THIRD SESSION, SHE REGAINED CONSCIOUSNESS, WITH NOTABLE REDUCTIONS IN BILIRUBIN AND AMMONIA LEVELS. THE TABLE 1 PRESENTS THE DAILY VARIATIONS OF LABORATORY PARAMETERS. THIS CASE UNDERSCORES THE FEASIBILITY AND EFFECTIVENESS OF SV-TPE IN MANAGING ALF. DESPITE HV-TPE BEING RECOMMENDED FOR ALF, IT IS RESOURCE-INTENSIVE AND CARRIES RISKS SUCH AS VOLUME OVERLOAD AND CEREBRAL EDEMA [3]. SV-TPE OFFERS A SAFER AND MORE PRACTICAL ALTER-NATIVE, PARTICULARLY IN RESOURCE-CONSTRAINED SETTINGS. EARLY INTERVENTION WITH SV-TPE LIKELY CONTRIBUTED TO THE FAVORABLE OUT-COME BY MITIGATING THE CYTOKINE STORM AND LOWERING AMMONIA LEVELS BEFORE IRREVERSIBLE MULTI-ORGAN FAILURE OCCURRED [5]. OUR EXPERIENCE INDICATES THAT SV-TPE CAN BE A VIABLE THERAPEUTIC OPTION FOR SEVERE ALF CASES, INCLUDING THOSE COMPLICATED BY DUAL INFECTIONS. THIS TREATMENT¿S SUCCESS, COUPLED WITH ITS RELATIVE SAFETY AND RESOURCE EFFICIENCY, SUGGESTS THAT SV-TPE DESERVES FURTHER CON-SIDERATION AND STUDY AS A STANDARD INTERVENTION IN ALF MANAGEMENT PROTOCOLS. SINCE THIS WAS A LETTER TO THE EDITOR AND IT WAS PUBLISHED IN 2024, THE LOT NUMBERS WERE NOT REQUESTED; THEREFORE, A DISPOSABLE LOT HISTORY SEARCH COULD NOT BE CONDUCTED. A REQUEST FOR LOT NUMBERS IS NOT FEASIBLE BECAUSE THERE ARE MANY MONTHS BETWEEN COLLECTION OF DATA, TO PEER REVIEW, TO FINAL PUBLICATION. THEREFORE, A DHR SEARCH COULD NOT BE CONDUCTED FOR THIS SPECIFIC INCIDENT. ALL LOTS MUST MEET ACCEPTANCE CRITERIA FOR RELEASE. ACCORDING TO THERAPEUTIC APHERESIS: A PHYSICIAN'S HANDBOOK, ADVERSE EVENTS OCCUR DURING THERAPEUTIC PROCEDURES WITH A FREQUENCY OF 4.8%. SOME OF THE MOST COMMON REACTIONS INCLUDE FEVER, URTICARIA, HYPOCALCEMIC SYMPTOMS, PRURITUS, DYSPNEA, TACHYCARDIA, AND MILD HYPOTENSION ROOT CAUSE: A ROOT CAUSE ASSESSMENT WAS PERFORMED FOR THE HYPOTENSION. BASED ON THE AVAILABLE INFORMATION A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. VASOVAGAL ARE COMMON SIDE EFFECTS OF THERAPEUTIC APHERESIS PROCEDURES. THEY ARE TYPICALLY CAUSED BY THE PATIENT'S DISEASE STATE, THE RATE OF AC INFUSION, THE LENGTH OF THE PROCEDURE, THE PATIENT'S SENSITIVITY TO THE PROCEDURE AND/OR THE HEMODYNAMIC STRESS OF THE PROCEDURE. CITATION: U.B DAVOOD, PANDEEP KAUR, AKARSHAN GUPTA, ANUNEET TRIPATHI, AMIT KUMAR CHATTERJEE, AMIT KUMAR, ANKITA NIGAM, SHOBNA BHATIA, HEPATITIS A AND LEPTOSPIROSIS DUAL INFECTION-INDUCED FULMINANT HEPATIC FAILURE SUCCESSFULLY TREATED WITH STANDARD VOLUME THERAPEUTIC PLASMA EXCHANGE, TRANSFUSION CLINIQUE ET BIOLOGIQUE, VOLUME 31, ISSUE 4, 2024, PAGES 265-266, ISSN 1246-7820, HTTPS://DOI.ORG/10.1016/J.TRACLI.2024.06.005. (HTTPS://WWW.SCIENCEDIRECT.COM/SCIENCE/ARTICLE/PII/S1246782024000673).

    Description of Event or Problem · 0

    PER JOURNAL ARTICLE "HEPATITIS A AND LEPTOSPIROSIS DUAL INFECTION-INDUCED FULMINANT HEPATIC FAILURE SUCCESSFULLY TREATED WITH STANDARD VOLUME THERAPEUTIC PLASMA EXCHANGE", BY U.B. DAVOOD, PANDEEP KAUR, AKARSHAN GUPTA, ANUNEET TRIPATHI, AMIT KUMAR CHATTERJEE, AMIT KUMAR, ANKITA NIGAM, SHOBNA BHATIA, THE SPECTRA OPTIA/C210 APHERESIS SYSTEM WAS UTILIZED FOR THERAPEUTIC PLASMA EXCHANGE IN A PATIENT WITH FULMINANT HEPATIC FAILURE DUE TO DUAL INFECTIONS. DURING THE FIRST PROCEDURE, THE PATIENT EXPERIENCED HYPOTENSION, WHICH NECESSITATED THE ADMINISTRATION OF INTRAVENOUS FLUIDS AND NORADRENALINE. THE HYPOTENSION COULD BE ATTRIBUTED TO THE THERAPEUTIC PROCEDURE, REQUIRING MONITORING AND MANAGEMENT DURING SUCH TREATMENTS. SUBSEQUENT PROCEDURES WERE CONDUCTED WITH A SLIGHTLY POSITIVE FLUID BALANCE, AND THE PATIENT'S CONDITION IMPROVED SIGNIFICANTLY. PATIENT IDENTIFICATION IS NOT AVAILABLE AT THIS TIME. THE PLATELET COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

    Description of Event or Problem · 0

    PER JOURNAL ARTICLE "HEPATITIS A AND LEPTOSPIROSIS DUAL INFECTION-INDUCED FULMINANT HEPATIC FAILURE SUCCESSFULLY TREATED WITH STANDARD VOLUME THERAPEUTIC PLASMA EXCHANGE", BY U.B. DAVOOD, PANDEEP KAUR, AKARSHAN GUPTA, ANUNEET TRIPATHI, AMIT KUMAR CHATTERJEE, AMIT KUMAR, ANKITA NIGAM, SHOBNA BHATIA, THE SPECTRA OPTIA/C210 APHERESIS SYSTEM WAS UTILIZED FOR THERAPEUTIC PLASMA EXCHANGE IN A PATIENT WITH FULMINANT HEPATIC FAILURE DUE TO DUAL INFECTIONS. DURING THE FIRST PROCEDURE, THE PATIENT EXPERIENCED HYPOTENSION, WHICH NECESSITATED THE ADMINISTRATION OF INTRAVENOUS FLUIDS AND NORADRENALINE. THE HYPOTENSION COULD BE ATTRIBUTED TO THE THERAPEUTIC PROCEDURE, REQUIRING MONITORING AND MANAGEMENT DURING SUCH TREATMENTS. SUBSEQUENT PROCEDURES WERE CONDUCTED WITH A SLIGHTLY POSITIVE FLUID BALANCE, AND THE PATIENT'S CONDITION IMPROVED SIGNIFICANTLY. A REQUEST FOR SPECIFIC PATIENT INFORMATION IS NOT FEASIBLE BECAUSE THERE ARE MANY MONTHS BETWEEN COLLECTION OF DATA, TO PEER REVIEW, TO FINAL PUBLICATION. THE PLATELET COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1482071 SPECTRA OPTIA SPECTRA OPTIA EXCHANGE SET LKN TERUMO BCT 05020583102200

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Female Other| R