BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPECTRA OPTIA

    MDR report key: 10040471 · Received May 8, 2020

    Report

    Report Number
    1722028-2020-00223
    Event Type
    Death
    Date Received
    May 8, 2020
    Date of Event
    September 14, 2015
    Report Date
    May 8, 2020
    Manufacturer
    TERUMO BCT
    Product Code
    LKN
    PMA / PMN Number
    K183081
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED TO PROVIDE ADDITIONAL INFORMATION IN H.6 AND H.10. INVESTIGATION: THE DECREASE IN FIBRINOGEN CONCENTRATIONS WAS HIGHEST AFTER THE FIRST TPE SESSION. THE DECREASE IN PLATELETS WAS MORE GRADUAL WITH THE LOWEST VALUES AT DAY 4. ROOT CAUSE: A DEFINITIVE ROOT CAUSE FOR THE PLATELET/FIBRINOGEN LOSSES COULD NOT BE DETERMINED. POSSIBLE CAUSES MAY BE DUE TO: PROCESSING LARGE VOLUME TBV, DILUTION EFFECT DUE TO LARGE VOLUME OF ACDA OR ACDA/HEPARIN INFUSED, PATIENT'S UNDERLYING DISEASE STATE ROOT CAUSE FOR THE PATIENT DEATH IS BELIEVED TO BE RELATED TO THE PATIENT'S PRE-EXISTING DISEASE STATE.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED TO PROVIDE ADDITIONAL INFOMATION IN H.10. INVESTIGATION: 8 PATIENTS EXPERIENCED DECREASE IN PLATELETS OVER TIME WITH UNKNOWN MEDICAL INTERVENTION. ACCORDING TO THERAPEUTIC APHERESIS: A PHYSICIAN'S HANDBOOK, WITH CURRENT CENTRIFUGAL TECHNOLOGY, REDUCTIONS IN PLATELET COUNT ARE USUALLY MODEST, AND LEVELS QUICKLY RETURN TO BASELINE. IN A SEVERELY THROMBOCYTOPENIC PATIENT, HOWEVER, SUCH A LOSS MAY MASK THE BEGINNING OF PLATELET RECOVERY. SIMILARLY, THE SMALL AMOUNT OF RED CELLS LOST IN THE APHERESIS CIRCUIT MAY BE MORE APPARENT IN AN ANEMIC PATIENT WHO HAS MEAGER PRODUCTION CAPACITY AND WHO IS RECEIVING MULTIPLE PROCEDURES. ALTHOUGH GENERALLY WELL TOLERATED, THE LARGE-VOLUME LEUKOCYTAPHERESIS FOR STEM CELL COLLECTIONS IN PATIENTS OFTEN RESULTS IN A DECLINE IN HEMATOCRIT AND PLATELET COUNT, PARTICULARLY BECAUSE SOME RED CELLS AND PLATELETS ARE INCIDENTALLY REMOVED WITH THE STEM CELLS. 8 PATIENTS EXPERIENCED A DECREASE IN FIBRINOGEN WHICH NECESSITATED DAILY MONITORING OF THE PLASMA FIBRINOGEN CONCENTRATIONS. ACCORDING TO THERAPEUTIC APHERESIS: A PHYSICIAN'S HANDBOOK, THERAPEUTIC APHERESIS PROCEDURES MAY LEAD TO MAJOR PHYSIOLOGICAL CHANGES, INCLUDING DEPLETION OF CELLULAR AND PLASMA CONSTITUENTS. PATIENT 4 DIED IN THE COURSE OF THE ACUTE ILLNESS DUE TO CEREBRAL EDEMA 11 DAYS AFTER TPE. THERE IS NO EVIDENCE TO INDICATE THAT THE SPECTRA OPTIA DEVICE CAUSED OR CONTRIBUTED TO THE DEATH OF THE PATIENT. THEREFORE, THERE IS NO FAILURE MODE OR ASSOCIATED RISK THAT CAN BE EVALUATED FOR SPECTRA OPTIA. DHR DETAILS: SINCE THIS WAS A RETROSPECTIVE STUDY TO EVALUATE 8 PEDIATRIC PATIENTS AGES 2-12 YEARS WITH A TOTAL OF 104 TPE SESSIONS PERFORMED ON SPECTRA OPTIA BETWEEN 2013 AND 2014 THE LOT NUMBERS ARE UNKNOWN; THEREFORE, DHR SEARCHES COULD NOT BE CONDUCTED FOR THE REPORTED INCIDENTS. ALL LOTS MUST MEET ACCEPTANCE CRITERIA FOR RELEASE. THE DISPOSABLE SETS WERE NOT AVAILABLE FOR RETURN. SINCE THIS WAS A RETROSPECTIVE STUDY TO EVALUATE 8 PEDIATRIC PATIENTS AGES 2-12 YEARS WITH A TOTAL OF 104 TPE SESSIONS PERFORMED ON SPECTRA OPTIA BETWEEN 2013 AND 2014, THE LOT NUMBERS ARE UNKNOWN. INVESTIGATION IS IN PROCESS. A FOLLOW UP REPORT WILL BE PROVIDED.

    Additional Manufacturer Narrative · 1

    LOT NUMBER AND EXPIRY INFORMATION ARE NOT AVAILABLE AT THIS TIME. ARTICLE CITATION: PRYTULA, A, ET AL. 2015. THERAPEUTIC PLASMA EXCHANGE IN CHILDREN WITH ACUTE AUTOIMMUNE CENTRAL NERVOUS SYSTEM DISORDERS. INTERNATIONAL JOURNAL OF ARTIFICIAL ORGANS. 2015. DOI: 10.5301/IJAO.5000435. INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Description of Event or Problem · 1

    THE ARTICLE, 'THERAPEUTIC PLASMA EXCHANGE IN CHILDREN WITH ACUTE AUTOIMMUNE CENTRAL NERVOUS SYSTEM DISORDERS' (PRYTULA 2015) DESCRIBES A STUDY ON A SERIES OF 8 CHILDREN AGED 2- 12 YEARS WITH TRANSVERSE MYELITIS, BICKERSTAFF¿S BRAINSTEM ENCEPHALITIS, NEUROMYELITIS OPTICA, AND ACUTE PARANEOPLASTIC OR UNSPECIFIED ENCEPHALITIS IN WHOM THERAPEUTIC PLASMA EXCHANGE (TPE) WAS USED AS A SECOND-LINE OR RESCUE TREATMENT. A TOTAL OF 104 TPE SESSIONS WERE PERFORMED WHERE 80-110 ML/KG OF PLASMA WAS EXCHANGED USING 4% ALBUMIN SOLUTION AND FRESH FROZEN PLASMA. IN 2013 AND 2014, 8 CHILDREN WERE TREATED WITH TPE, 7 OF WHOM REQUIRED PICU ADMISSION AND 5 MECHANICAL VENTILATION. THE UNDERLYING DIAGNOSES WERE TRANSVERSE MYELITIS (N = 3), NEUROMYELITIS OPTICA (N = 1), AUTOIMMUNE PARANEOPLASTIC ENCEPHALITIS (N = 1), PRESUMABLY AUTOIMMUNE MEDIATED ENCEPHALITIS (N = 2), AND BICKERSTAFF¿S BRAINSTEM ENCEPHALITIS (N = 1). THE CLINICAL CHARACTERISTICS OF ALL PATIENTS ARE LISTED IN TABLE I. THE TREATMENTS CONCOMITANT TO TPE INCLUDED CORTICOSTEROIDS IN ALL PATIENTS, ANTICONVULSANTS DIPHANTOINE AND PHENOBARBITAL IN PATIENT 3, THIOPENTAL, LEVETIRACETAM, VALPROATE, CLONAZEPAM, AND PIRACETAM IN PATIENT 4, ANTIBIOTICS/ANTIVIRALS IN PATIENTS 2 TO 8, SEDATIVES INCLUDING MIDAZOLAM, FENTANYL, AND CLONIDINE IN PATIENTS 3, 5, 6 AND 8, AND VASOPRESSORS IN PATIENTS 4, 6, AND 8. SIX EPISODES OF TPE-RELATED ADVERSE EVENTS OTHER THAN VASCULAR ACCESS ISSUES (5.7% OF ALL SESSIONS) WERE DOCUMENTED IN 2 CHILDREN: HYPOTENSION WITH SYSTOLIC BLOOD PRESSURE <50 MMHG IN PATIENT 6 WITH WEIGHT (B)(6) KG (N = 4) AND IN PATIENT 7 AN ALLERGIC REACTION TO FFP (N = 1) AND SYMPTOMATIC HYPOCALCEMIA WITH ICA 0.86 MMOL/L DUE TO A TECHNICAL DEFECT OF THE INFUSION PUMP (N = 1). THE CHILD WITH HYPOTENSION WAS HEMODYNAMICALLY INSTABLE OUTSIDE TPE SESSIONS AS WELL AND THE DECREASE IN BLOOD PRESSURE CANNOT BE ATTRIBUTED SOLELY TO TPE. TO PREVENT HYPOTENSION, THE VASOPRESSOR INFUSION RATE WAS TEMPORARILY INCREASED. DURING EPISODES OF HYPOTENSION BOLUSES OF STABLE SOLUTION OF PLASMA PROTEIN WERE ADMINISTERED. THE ALLERGIC REACTION OCCURRED SHORTLY AFTER COMMENCEMENT OF FFP INFUSION. ITS SYMPTOMS WERE TACHYCARDIA AND SKIN RASH. THERE WERE NO RESPIRATORY SYMPTOMS. THE INFUSION OF FFP WAS TERMINATED IMMEDIATELY, THE CHILD RECEIVED A FLUID BOLUS AND ANTIHISTAMINES. PER THE ARTICLE, ONE PATIENT DIED IN THE COURSE OF THE ACUTE ILLNESS IN THE PICU BECAUSE OF CEREBRAL EDEMA. IN VIEW OF THE FULMINANT CLINICAL COURSE, REFRACTORY TO ALL APPLIED THERAPIES, A DIAGNOSIS OF ACUTE NECROTIZING ENCEPHALOPATHY WAS MADE. THE PATIENT DEATH OCCURRED 11 DAYS AFTER STARTING TPE. PER THE ARTICLE, THERAPY PROCEEDING TPE FOR THIS PATIENT WAS MEP THIOPENTAL INDUCED COMA, ANTIBIOTICS AND ANTIVIRALS. THE DISPOSABLE SET 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, THERE IS NO ALLEGATION THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    501658 SPECTRA OPTIA SPECTRA OPTIA EXCHANGE SET LKN TERUMO BCT

    Patients

    Seq Age Sex Outcome Treatment
    1 00012 YR Female Other