BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA OPTIA

    MDR report key: 10083631 · Received May 22, 2020

    Report

    Report Number
    1722028-2020-00247
    Event Type
    Injury
    Date Received
    May 22, 2020
    Date of Event
    June 27, 2017
    Report Date
    May 22, 2020
    Manufacturer
    TERUMO BCT
    Product Code
    LKN
    UDI-DI
    05020583102200
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: ACCORDING TO THERAPEUTIC APHERESIS: A PHYSICIAN'S HANDBOOK, ADVERSE EVENTS OCCUR DURING THERAPEUTIC PROCEDURES WITH A FREQUENCY OF (B)(4). SOME OF THE MOST COMMON REACTIONS INCLUDE FEVER, URTICARIA, HYPOCALCEMIC SYMPTOMS, PRURITUS, DYSPNEA, TACHYCARDIA, AND MILD HYPOTENSION. TRANSIENT HYPOCALCEMIA ASSOCIATED WITH APHERESIS IS USUALLY WELL TOLERATED. SYMPTOMS OFTEN SHOW AS PARESTHESIA (TINGLING) BUT PATIENTS MAY ALSO EXPERIENCE UNUSUAL TASTE, NAUSEA, LIGHTHEADEDNESS, SHIVERING, AND TREMORS. SEVERE HYPOCALCEMIA MAY ALSO CAUSE MUSCLE CONTRACTIONS AND CAN PROGRESS TO TETANY AND SEIZURES IF HYPOCALCEMIA ESCALATES AND IS NOT CORRECTED. VASOVAGAL INCIDENTS OCCUR AROUND (B)(4)OF PROCEDURES. THE REACTIONS GENERALLY MANIFEST AS PALLOR AND DIAPHORESIS. IN A FULL BLOWN ATTACK, THE REACTION PROGRESSES FROM PALLOR AND SWEATING TO PULSE SLOWING AND BLOOD PRESSURE DECREASING. MORE SEVERE VASOVAGAL REACTIONS MAY INCLUDE NAUSEA, VOMITING, AND/OR CONVULSIONS. SYMPTOMS OF ALLERGIC REACTIONS MAY INCLUDE HIVES, DYSPNEA, WHEEZING, BURNING EYES, TACHYCARDIA, HYPOTENSION, AND OR FACIAL SWELLING AND FLUSHING. MILD REACTIONS CAN BE TREATED WITH DIPHENHYDRAMINE ADMINISTERED THROUGH AN IV. WHEN PLASMA IS EXCHANGED WITH A NON-PLASMA REPLACEMENT SOLUTION, COAGULOPATHY CAUSED BY DILUTION OF COAGULATION FACTOR IS A POTENTIAL PROBLEM. THE PROTHROMBIN TIME AND ACTIVATED PARTIAL THROMBOPLASTIN TIME RISE AND FIBRINOGEN FALLS TO AN EXTENT RELATED TO THE INTENSITY OF THE EXCHANGE. DESPITE THESE HEMOSTATIC ALTERATIONS, HEMORRHAGIC COMPLICATIONS OF DILUTIONAL COAGULOPATHY ARE SELDOM ENCOUNTERED UNLESS A PATIENT IS HEMOSTATICALLY COMPROMISED BEFORE TREATMENT. THE CUSTOMER DID NOT PROVIDE THE LOT NUMBER PERTAINING TO THIS EVENT, THEREFORE A DEVICE HISTORY RECORD (DHR) SEARCH COULD NOT BE CONDUCTED FOR THIS SPECIFIC INCIDENT. ALL LOTS MUST MEET ACCEPTANCE CRITERIA BEFORE RELEASE. ROOT CAUSE: THE AUTHORS ATTRIBUTED THE PATIENT'S ALLERGIC REACTION TO THE FRESH FROZEN PLASMA. THEY CHARACTERIZED THE OTHER PATIENT'S INFECTION AS CATHETER-ASSOCIATED INFECTION. WHEN PLASMA IS EXCHANGED WITH A NON-PLASMA REPLACEMENT SOLUTION, COAGULOPATHY CAUSED BY DILUTION OF COAGULATION FACTOR IS A POTENTIAL PROBLEM. THE PROTHROMBIN TIME AND ACTIVATED PARTIAL THROMBOPLASTIN TIME RISE AND FIBRINOGEN FALLS TO AN EXTENT RELATED TO THE INTENSITY OF THE EXCHANGE. A DEFINITIVE ROOT CAUSE FOR THE REPORTED CITRATE REACTIONS COULD NOT BE DETERMINED. THESE REACTIONS OCCUR DUE TO DECREASED IONIZED CALCIUM IN CIRCULATION AS A RESULT OF EXOGENOUS CITRATE ADMINISTERED DURING THE APHERESIS PROCEDURE AND ARE INFLUENCED BY PATIENT PHYSIOLOGY, THE PATIENT'S DISEASE STATE, THE RATE OF AC INFUSION, THE CITRATE CONTENTS IN THE REPLACEMENT FLUID, AND/OR THE LENGTH OF THE PROCEDURE. THESE SYMPTOMS MAY BE TREATED WITH ORAL OR INTRAVENOUS CALCIUM SUPPLEMENTS OR BY ADJUSTING THE AC INFUSION RATE. THE OTHER REPORTED ADVERSE EVENTS 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. A SPECIFIC ROOT CAUSE FOR THE DISLOCATION OF PERIPHERAL VASCULAR ACCESS COULD NOT BE DETERMINED. POSSIBLE ROOT CAUSES INCLUDE BUT ARE NOT LIMITED TO: - THE PATIENT'S ACCESS WAS NOT PROPERLY POSITIONED - ARM MOVEMENT CAUSING THE DISLOCATION OF THE ACCESS.

    Description of Event or Problem · 0

    THIS STUDY IS A RETROSPECTIVE ANALYSIS OF DATA REGARDING GLUCOCORTICOSTEROIDS (GCS) AS FIRST-LINE AND THERAPEUTIC PLASMA EXCHANGE (TPE) USING SPECTRA OPTIA AS SECOND-LINE TREATMENTS FROM (B)(4) PATIENTS BETWEEN 2001 AND 2014. A REQUEST FOR SPECIFIC PATIENT INFORMATION IS NOT FEASIBLE. THE POPULATION CONSISTED OF (B)(4) FEMALE AND (B)(4)MALE PATIENTS. AGE WAS 32.0 (15¿73).

    Additional Manufacturer Narrative · 1

    LOT NUMBER AND EXPIRY INFORMATION ARE NOT AVAILABLE AT THIS TIME. ARTICLE CITATION: EHLER, J, ET. AL. 2017. TREATMENT OF THE FIRST ACUTE RELAPSE FOLLOWING THERAPEUTIC PLASMA EXCHANGE IN FORMERLY GLUCOCORTICOSTEROID-UNRESPONSIVE MULTIPLE SCLEROSIS PATIENTS¿A MULTICENTER STUDY TO EVALUATE GLUCOCORTICOSTEROID RESPONSIVENESS. INTERNATIONAL JOURNAL OF MOLECULAR SCIENCES. INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Description of Event or Problem · 1

    IN THE ARTICLE, 'TREATMENT OF THE FIRST ACUTE RELAPSE FOLLOWING THERAPEUTIC PLASMA EXCHANGE IN FORMERLY GLUCOCORTICOSTEROID-UNRESPONSIVE MULTIPLE SCLEROSIS PATIENTS¿A MULTICENTER STUDY TO EVALUATE GLUCOCORTICOSTEROID RESPONSIVENESS' (EHLER 2017), A STUDY WAS DONE ON THERAPEUTIC PLASMA EXCHANGE (TPE) IN MULTIPLE SCLEROSIS (MS) PATIENTS. BETWEEN 2001 AND 2014, A TOTAL OF 37 PATIENTS WITH GLUCOCORTICOSTEROID (GCS)-UNRESPONSIVE MS RELAPSES WERE TREATED WITH TPE. THE POPULATION CONSISTED OF 29 FEMALE AND EIGHT MALE PATIENTS. SIX PATIENTS WITH CLINICALLY ISOLATED SYNDROME (CIS), 24 WITH RELAPSING-REMITTING MS (RR-MS), SIX SECONDARY-PROGRESSIVE MS (SP-MS) PATIENTS WITH SUPERIMPOSED RELAPSES, AND ONE PRIMARY-PROGRESSIVE MS (PP-MS) PATIENT WITH ACUTE WORSENING SYMPTOMS WERE INCLUDED. ALL 37 PATIENTS RECEIVED A CONVENTIONAL HIGH-DOSE GCS TREATMENT (1GMP/DAY OVER5 CONSECUTIVE DAYS) FOR RELAPSE TREATMENT. THE MEDIAN TIME FROM RELAPSE ONSET TO THE START OF GCS TREATMENT WAS 7 DAYS (RANGE 1¿60 DAYS). AN "ULTRA" HIGH-DOSE GCS TREATMENT (2 G MP/DAY GIVEN DAILY OVER 5 CONSECUTIVE DAYS)WAS ADMINISTERED ADDITIONALLY TO 18 OF THE 37 PATIENTS(48.7%). FOR 19 OF THE 37 PATIENTS, TPE WAS PERFORMED WITHOUT AN "ULTRA" HIGH-DOSE GCS TREATMENT DUE TO RAPID DISEASE PROGRESSION, SEVERE ADVERSE EVENTS DUE TO GCS, PRIOR GCS TREATMENT IN AN EXTERNAL HOSPITAL, OR UNRESPONSIVENESS TO GCS DURING INTERMITTENT GCS TREATMENT. A MEDIAN OF 5 SINGLE TPE SESSIONS PER PATIENT WAS PERFORMED (RANGE 2¿9 SINGLE SESSIONS). THE MEDIAN TIME FROM RELAPSE ONSET TO THE INITIATION OF TPE WAS 44 DAYS (RANGE 11¿154 DAYS). THE MEDIAN TIME BETWEEN THE END OF GCS TREATMENT AND THE BEGINNING OF TPE WAS 15 DAYS (RANGE 0¿98 DAYS). AT ONE OF THE SITES INCLUDED IN THE STUDY (I.E., VIENNA, AUSTRIA), TPE WAS PERFORMED WITH SPECTRA OPTIA. HOWEVER, THE NUMBER OF PROCEDURES PERFORMED WITH SPECTRA OPTIA IS NOT PROVIDED. ADVERSE EVENT DATA IS PROVIDED FOR TPE, BUT NOT BASED ON THE BRAND OF APHERESIS DEVICE USED. ADVERSE EVENT N TREATMENT ALLERGIC REACTION TO FRESH FROZEN PLASMA 1 ANTIHISTAMINES AND PREDNISOLONE HYPOCALCAEMIA 1 10% CALCIUM GLUCONATE DISLOCATION OF PERIPHERAL VASCULAR ACCESS AT END OF TREATMENT 1 REMOVAL OF VASCULAR ACCESS MODERATE ARTERIAL HYPOTENSION 2 CRYSTALLOID INFUSION SPECIFIC DETAILS ABOUT THE PATIENTS, SUCH AS PATIENT INFORMATION, IS NOT INCLUDED IN THE ARTICLE, THEREFORE THIS REPORT IS BEING FILED AS A SUMMARY OF THESE EVENTS. THE DISPOSABLE SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546112 SPECTRA OPTIA SPECTRA OPTIA EXCHANGE SET EA LKN TERUMO BCT 10220 05020583102200

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| O