SPECTRA OPTIA
Report
- Report Number
- 1722028-2025-00280
- Event Type
- Death
- Date Received
- December 22, 2025
- Date of Event
- November 3, 2025
- Report Date
- December 22, 2025
- Manufacturer
- TERUMO BCT
- Product Code
- LKN
- UDI-DI
- 05020583122208
- PMA / PMN Number
- K183081
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
LOT NUMBER AND EXPIRY INFORMATION ARE NOT AVAILABLE AT THIS TIME. INVESTIGATION: PER THE ARTICLE THE CONCLUSION WAS STATED AS FOLLOWS: "ADVERSE EVENTS CALCULATED FOR OVER 50000 THERAPEUTIC APHERESIS PROCEDURES PERFORMED ON THE SPECTRA OPTIA FOUND AE RATES SIMILAR TO OR LOWER THAN RATES REPORTED PREVIOUSLY BY OTHER INSTITUTIONS AND REGISTRIES. THE AVERAGE RATE OF SERIOUS ADVERSE EVENTS WAS 0.21% WHILE THE AVERAGE MILD AND MODERATE AES WERE 1.43% AND 2.81%, RESPECTIVELY. PATIENT DEATHS ASSOCIATED WITH APHERESIS ARE EXCEEDINGLY RARE. PROVIDERS SHOULD SEEK DEVICE-SPECIFIC, REAL-WORLD SAFETY DATA WHEN IT IS AVAILABLE AND APPLY THE INFORMATION TO MINIMIZE PATIENT SAFETY RISK DURING THERAPEUTIC APHERESIS PROCEDURES." INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED. CITATION: HAUBNER, A., MENDOZA, S., WITT, V., DEEREN, D., BOJANIC, I., GASOVA, Z., GLATT, T. N., VASILACHE, A. M., NEWMAN, E., STRINEHOLM, V., & SKOSANA, Y. (2025B). REAL-WORLD SAFETY DATA FROM THE WORLD APHERESIS ASSOCIATION REGISTRY FOR THE SPECTRA OPTIA APHERESIS SYSTEM. JOURNAL OF CLINICAL APHERESIS, 40(6), E70079. HTTPS://DOI.ORG/10.1002/JCA.70079.
THIS REPORT IS BEING FILED TO PROVIDE ADDITIONAL INFORMATION IN H.6 AND H.11. LOT NUMBER AND EXPIRY INFORMATION ARE NOT AVAILABLE AT THIS TIME. INVESTIGATION: PER THE ARTICLE THE CONCLUSION WAS STATED AS FOLLOWS: "ADVERSE EVENTS CALCULATED FOR OVER 50000 THERAPEUTIC APHERESIS PROCEDURES PERFORMED ON THE SPECTRA OPTIA FOUND AE RATES SIMILAR TO OR LOWER THAN RATES REPORTED PREVIOUSLY BY OTHER INSTITUTIONS AND REGISTRIES. THE AVERAGE RATE OF SERIOUS ADVERSE EVENTS WAS 0.21% WHILE THE AVERAGE MILD AND MODERATE AES WERE 1.43% AND 2.81%, RESPECTIVELY. PATIENT DEATHS ASSOCIATED WITH APHERESIS ARE EXCEEDINGLY RARE. PROVIDERS SHOULD SEEK DEVICE-SPECIFIC, REAL-WORLD SAFETY DATA WHEN IT IS AVAILABLE AND APPLY THE INFORMATION TO MINIMIZEPATIENT SAFETY RISK DURING THERAPEUTIC APHERESIS PROCEDURES." INVESTIGATIONAL DETAILS: THE PURPOSE OF THE JOURNAL ARTICLE STUDY IS NOTED IN THE ARTICLE ABSTRACT: ABSTRACT: IN THIS STUDY WE ANALYZED 12 YEARS OF ADVERSE EVENTS, (AE) DATA FROM THE WORLD APHERESIS ASSOCIATION, (WAA) REGISTRY SPECIFIC TO THE SPECTRA OPTIA APHERESIS SYSTEM. WE QUERIED WAA REGISTRY DATA, (2012¿2023) ON APHERESIS PROCEDURES PERFORMED EXCLUSIVELY ON THE SPECTRA OPTIA APHERESIS SYSTEM. WE CATEGORIZED AES BY SEVERITY, (MILD, MODERATE, AND SEVERE), AND ORDERED THEM BY YEAR. WE THEN ANALYZED AND PRESENTED AES ASSOCIATED WITH THE FOLLOWING VARIABLES: DIAGNOSIS, PROCEDURE TYPE, VASCULAR ACCESS, AND REPLACEMENT FLUID TYPE, AND CAUSES OF PROCEDURAL INTERRUPTION. WE IDENTIFIED 51 567 APHERESIS PROCEDURES SPECIFIC TO THE SPECTRA OPTIA APHERESIS SYSTEM WITHIN THE DATA SET. AE RATES FROM 2012 TO 2023 FOR MILD, MODERATE, AND SEVERE WERE 1.43%, 2.81%, AND 0.21%, RESPECTIVELY. PROCEDURES ASSOCIATED WITH THE LOWEST AE RATES INCLUDE RED BLOOD CELL EXCHANGE AND THERAPEUTIC PLASMA EXCHANGE. THE MOST COMMON MILD AND MODERATE AES INCLUDE TINGLING AND HYPOTENSION AND AES RELATED TO VASCULAR ACCESS. THE HIGHEST RATES OF MILD AND MODERATE AES WERE ASSOCIATED WITH CELLULAR COLLECTIONS. THE HIGHEST RATE OF SEVERE AES WAS ASSOCIATED WITH THE USE OF 3.5% ALBUMIN AS REPLACEMENT FLUID. OTHER VARIABLES IMPACTING PATIENT SAFETY ARE IDENTIFIED. AE RATES COULD NOT BE COMPARED TO THE MEDIAN LENGTH OF PROCEDURE SINCE THIS TIME VARIABLE IS NOT CURRENTLY COLLECTED IN THE REGISTRY. THIS IS THE FIRST DEVICE- SPECIFIC ANALYSIS OF THE WAA REGISTRY DATA, BRINGING PRIOR SAFETY REPORTING INTO EVEN SHARPER FOCUS. DEVICE- SPECIFIC SAFETY ANALYSIS LIKE THIS WILL HELP PRACTITIONERS BETTER UNDERSTAND POTENTIAL SAFETY CONCERNS ASSOCIATED WITH A COMMONLY USED APHERESIS DEVICE, INCLUDING VARIOUS SEPARATION MODALITIES AND ACCESSORIES, THUS SUPPORTING IMPROVED PROCEDURE MANAGEMENT. SUMMARY OF TERUMO BCT PRODUCT IN RELATION TO THE JOURNAL ARTICLE: THERAPEUTIC APHERESIS (TA), IS PRESCRIBED TO PATIENTS AS A FIRST OR SECOND LINE THERAPY FOR UP TO 45 LISTED DISEASES AND CONDITIONS ACCORDING TO THE AMERICAN SOCIETY FOR APHERESIS (ASFA) MOST RECENT 2023 GUIDANCE. TA IS FREQUENTLY UTILIZED IN THE CHRONIC MANAGEMENT OF NUMEROUS DISEASES AND MAY ALSO BE USED WHEN DRUG THERAPY FAILS OR IN CASES OF LIFE- THREATENING EMERGENCIES. WHILE APHERESIS RELATED ADVERSE EVENTS HAVE BEEN REPORTED PREVIOUSLY, MOST ARE FROM SINGLE SITES OF CARE OR ARE LIMITED IN THE VARIETY OF APHERESIS PROTOCOLS EXAMINED. MORE COMPREHENSIVE ANALYSES DRAW FROM A LARGE POOL OF PATIENT DATA AND COVER A WIDE VARIETY OF APHERESIS PROCEDURES. THE BEST DATA, HOWEVER, COVER MANY SITES OF CARE AND INCLUDE THE LARGEST POOL OF PROCEDURAL DATA AVAILABLE. TOWARD THIS GOAL, SEVERAL PROMINENT GROUPS MAINTAIN LARGE AND ACTIVE REGISTRIES AND HAVE REPORTED ADVERSE EVENTS TO VARYING DEGREES. THESE INCLUDE THE AMERICAN SOCIETY FOR APHERESIS (ASFA) DISEASE REGISTRY [10], THE GLOBIN REGIONAL DATA AND DISCOVERY, (GRNDAD) REGISTRY, AND THE WORLD APHERESIS ASSOCIATION (WAA)- WORLD APHERESIS REGISTRY THE AIM OF THIS ARTICLE WAS TO OBTAIN IMPORTANT SAFETY DATA SPECIFIC TO THE SPECTRA OPTIA, A WIDELY USED CONTINUOUS- FLOW, CENTRIFUGE- BASED APHERESIS SYSTEM MANUFACTURED BY TERUMO BLOOD AND CELL TECHNOLOGIES INC. WHILE SAFETY DATA FOR APHERESIS PROCEDURES PERFORMED USING THE SPECTRA OPTIA HAVE BEEN REPORTED PREVIOUSLY, THE SIZE OF THE DATA POOLS WAS LIMITING, ESPECIALLY WHEN TRYING TO QUANTIFY THE REAL- WORLD RISK OF VERY RARE SERIOUS ADVERSE EVENTS THAT CAN OCCUR AT RATES OF < 0.1%. WITH THIS IN MIND, THE AUTHORS DISAGGREGATED RECENT DATA FROM THE WAA REGISTRY, REPORTING ONLY ON THERAPEUTIC APHERESIS PROCEDURES PERFORMED USING THE SPECTRA OPTIA TO BETTER DEFINE POTENTIAL DEVICE- SPECIFIC SAFETY CONSIDERATIONS. FOR THE PERIOD COVERED IN THIS ANALYSIS, DATA HAD BEEN CONTRIBUTED FROM A TOTAL OF 29 CENTERS FROM 13 COUNTRIES DURING THE ANALYSIS PERIOD, (JANUARY 1, 2012 TO DECEMBER 31, 2023), FOR A TOTAL OF 12 YEARS. WHEN APPROPRIATE, A SMALL NUMBER OF PROCEDURE SUBTYPES WERE MERGED INTO A SINGLE GROUP FOR SIMILAR PROCEDURES, AND DISEASES AND CONDITIONS WERE SIMILARLY MERGED INTO A SINGLE DIAGNOSTIC CODE, SUCH AS FOR CELL COLLECTION/REMOVAL INCLUDING THE COLLECTION OF STEM CELLS FOR TRANSPLANTATION (SCT), MONONUCLEAR CELLS OR REMOVAL OF VARIOUS CELLS, FOR INSTANCE LEUKOCYTES/BLASTS AND ERYTHROCYTES. SOME INFORMATION GAPS EXISTED FOR VARIABLES SUCH AS DIAGNOSIS, (SINCE NOT ALL PATIENTS RECEIVED A CLEAR DIAGNOSIS), ADVERSE EVENTS (SINCE SOMETIMES NO REGISTRATION WAS DONE, BUT NOT WAS INTERPRETED AS A LACK OF AE), SOME WITH A GRADING OF SEVERITY OF AE BUT NO SYMPTOMS RECORDED AND OTHERS VICE VERSA. REPLACEMENT FLUID WAS REPORTED IN REGARD TO ALBUMIN, DEXTRAN, AND VARIOUS PLASMA COMPOUNDS, OR COMBINATIONS OF THESE. IN PROCEDURES OF CELL COLLECTION AND IMMUNOADSORPTION FLUID WAS ADDED AS AN ANTICOAGULANT OR JUST AS AN ADDITIVE. DUE TO THE COMPLEXITY OF THE DATA AND THE LACK OF OTHER DATA DETAILS LIKE PATIENT CO- MORBIDITIES AND DISEASE CONDITION SEVERITY, DESCRIPTIVE STATISTICS WERE DEEMED TO BE MOST APPROPRIATE TO SUMMARIZE THE DATA. REGARDING TERUMO BCT PRODUCT, SPECTRA OPTIA, THE AUTHORS ANALYSIS OF THE WAA REGISTRY DATA FOR THE FULL 12 YEARS (2012-2023) IDENTIFIED 51,576 APHERESIS PROCEDURES IN 13,002 PATIENTS, PERFORMED EXCLUSIVELY ON THE SPECTRA OPTIA OUT OF 125,657 PROCEDURES IN TOTAL, (41.0% OF ALL PROCEDURES ANALYZED). ON AVERAGE, 4298 PROCEDURES WERE PERFORMED ON SPECTRA OPTIA PER YEAR. ON AVERAGE, 22 CENTERS PARTICIPATED IN REGISTRY REPORTING ANNUALLY. ANALYSIS REVEALED 53.4% OF OPTIA PROCEDURES WERE PERFORMED ON MALE PATIENTS COMPARED TO 46.6% FEMALE PATIENTS. MEDIAN AGE 55 YEARS (BETWEEN 0 AND 94 YEARS, OF WHOM 5.6% WERE 0¿18 YEARS). THE TOTAL ADVERSE EVENTS (AES) IN THE WAA REGISTRY FOR PROCEDURES CARRIED OUT ON THE SPECTRA OPTIA WERE DISTRIBUTED BY SEVERITY AND THE YEAR RECORDED IN THE REGISTRY. MILD AE RATES WERE CONSISTENT OVER THE PERIOD ANALYZED, RANGING BETWEEN 1%¿2%. MODERATE WAS MORE VARIABLE, RANGING BETWEEN 2%¿5%. SEVERE AE RATES APPEARED CONSISTENT OVER THE PERIOD ANALYZED, REMAINING BELOW 0.5%. THE AUTHORS CALCULATED AN AVERAGE OF 1.43% MILD, 2.81% MODERATE, AND 0.21% SEVERE AE RATES FOR THE PERIOD ANALYZED. WITHIN THE DATA SET, ONE PATIENT DEATH WAS NOTED WHERE THE IMPACT OF THE APHERESIS PROCEDURE COULD NOT HAVE BEEN RULED OUT. FOLLOW UP WITH THE AUTHOR (SEE ATTACHMENTS) CONFIRMED THAT THE DEATH REPORTED HEREIN ORIGINATED FROM THE PUBLICATION TITLED ¿USING THE WORLD APHERESIS ASSOCIATION REGISTRY HELPS TO IMPROVE THE TREATMENT QUALITY OF THERAPEUTIC APHERESIS¿ BY STEGMAYR ET AL. 2021. THIS PAPER ALLEGES THAT ONE DEATH WHICH MAY HAVE BEEN RELATED TO THE APHERESIS PROCEDURE WAS REPORTED IN THE TOTAL OF 104,000 TREATMENTS. THIS CASE WAS AN ELDERLY, SEVERELY ILL PATIENT WHO DIED FROM MYOCARDIAL INFARCTION DURING THE PROCEDURE, HOWEVER THE ARTICLE WAS A RETROSPECTIVE STUDY COMPARING THE ADVERSE EVENTS ASSOCIATED WITH APHERESIS PROCEDURES USING MULTIPLE COMPETITOR PLATFORMS, AND THERE IS NO DISCERNIBLE INFORMATION TO ATTRIBUTE THE REPORTED DEATH WITH THE SPECTA OPTIA DEVICE. IN ORDER TO DEFINE THE AE PROFILE SPECIFIC TO EACH THERAPEUTIC APHERESIS PROCEDURE TYPE, THE AUTHORS ORGANISED THE AE DATA BY SEVERITY AND RANKED BY PROCEDURE TYPE. ANALYSIS REVEALS UNREMARKABLE DIFFERENCES AMONG SEVERE AE RATES FOR MOST PROCEDURES. ELEVATED MILD AND MODERATE AE RATES WERE NOTED FOR AUTOLOGOUS AND DONOR STEM CELL COLLECTIONS. THE AUTHORS THEN ORGANIZED THE AE RATES BY DIAGNOSIS WHICH OUTLINED A WIDE RANGE FOR MILD AND MODERATE AES, WITH MILD AE RATES ABOVE 5% REPORTED FOR DONOR STEM CELL COLLECTION AND NON- HODGKIN, B- CELL LYMPHOMA, UNSPECIFIED. THEY FOUND MODERATE AE RATES ABOVE 10% FOR CATEGORIES REPORTED AS DONOR STEM CELL COLLECTION AND LYMPHOMA UNSPECIFIED. DIAGNOSES WITH THE HIGHEST RATES OF SEVERE AES WERE OBSERVED IN GUILLAIN- BARRÉ SYNDROME ACUTE AND WALDENSTRÖM MACROGLOBULINEMIA. THE AUTHORS NEXT ORGANIZED THE TOP 10 REPORTED AES CATEGORIES BY SEVERITY AMONG ALL PROCEDURES EXAMINED. THE MOST COMMON MILD AES WERE RELATED TO TINGLING, VASCULAR ACCESS CATEGORIES (COMBINED), AND HYPOTENSION. FOR MODERATE AES, THE MOST COMMON WERE TINGLING, (BY FAR THE MOST COMMON), URTICARIA, AND HYPOTENSION. FOR SEVERE AES, IT WAS AGAIN URTICARIA, HYPOTENSION, AND TINGLING, SIMILAR TO MODERATE BUT IN A DIFFERENT RANK ORDER. VASCULAR ACCESS WAS MAINLY ONLY ASSOCIATED WITH MILD AES. THIS REPORT FOUND THAT THE SPECTRA OPTIA PERFORMS TA PROCEDURES WITH AE RATES SIMILAR TO OR BELOW PREVIOUSLY PUBLISHED RATES ACROSS NEARLY ALL VARIABLES EXAMINED. THIS IMPLIES NO SPECIAL SAFETY SIGNALS ASSOCIATED SPECIFICALLY WITH THE USE OF THE SPECTRA OPTIA APHERESIS SYSTEM, EXPANDING UPON RECENT ANALYSES FROM THE SAME WAA REGISTRY DATA. ELEVATED RATES AMONG MILD AND MODERATE AES WERE FOUND TO BE ASSOCIATED WITH ONLY A HANDFUL OF PROCEDURES RECORDED IN THE REGISTRY. AS AN EXAMPLE, IT IS KNOWN THAT FIRST- TIME AUTOLOGOUS AND ALLOGENEIC DONORS WILL OFTEN REPORT RELATIVELY HIGH RATES OF MILD AND MODERATE AES DURING THE COLLECTION PROCESS. THE AUTHORS CONCLUDED THAT THIS IS PRESUMABLY BECAUSE THE PATIENTS ARE NAÏVE TO THE TYPICAL DISCOMFORTS AND INCONVENIENCES OF THE COLLECTION PROCEDURE. IN CONTRAST, PATIENTS WITH MORE EXPERIENCE WITH TA PROCEDURES OFTEN REPORT THE SAME AES BUT AT SUBSTANTIALLY LOWER RATES. SIDE EFFECTS EXPERIENCED DURING STEM CELL COLLECTIONS COULD ALSO BE ASSOCIATED WITH THE LENGTH OF THE COLLECTION PROCEDURE AND POSSIBLY ELEVATED AC EXPOSURE OR THE CELL MOBILIZATION MEDICATION. SINCE THE POSSIBILITY OF AN AE INCREASES WITH THE LENGTH OF THE APHERESIS PROCEDURE. ONE SUCH VARIABLE FOUND TO BE ASSOCIATED WITH THE HIGHEST RATE OF SEVERE AES, (ABOVE 1.0%), WAS THE USE OF ALBUMIN AT 3.5% AS THE REPLACEMENT FLUID. ALBUMIN AT THIS CONCENTRATION WAS REPORTED PREVIOUSLY TO BE ASSOCIATED WITH AN EXCESSIVELY HIGH AE RATE, DUE TO AN ELEVATED RATE OF HYPOTENSION REACTIONS. SINCE NUMEROUS DISEASES ARE INFLUENCING THE VASCULAR TONUS AND AUTONOMIC NERVOUS SYSTEM OF THE PATIENT THERE MAY APPEAR A DELAY IN VASCULAR CONSTRICTION AND CARDIAC RESPONSE UPON HYPOVOLEMIA, ESPECIALLY IF THE REPLACEMENT FLUID INFUSED IS LAGGING. THE AUTHORS RECOMMENDED THAT APHERESIS PROVIDERS SHOULD STRONGLY CONSIDER USING 5% ALBUMIN WHEN SUCH RISK IS EXPECTED, AND ESPECIALLY WHEN SERUM ALBUMIN IS LOWERED DUE TO THE UNDERLYING DISEASE. THE AUTHORS CONCLUDED THAT THE AVERAGE RATE OF SERIOUS ADVERSE EVENTS WAS 0.21% WHILE THE AVERAGE MILD AND MODERATE AES WERE 1.43% AND 2.81%, RESPECTIVELY. PATIENT DEATHS ASSOCIATED WITH APHERESIS ARE EXCEEDINGLY RARE. SINCE THIS WAS A RETROSPECTIVE STUDY REVIEWING APHERESIS PROCEDURES BETWEEN 2012-2023; THE LOT NUMBERS WERE NOT REQUESTED; THEREFORE, A DISPOSABLES LOT HISTORY SEARCH COULD NOT BE CONDUCTED FOR THIS SPECIFIC INCIDENT. ACCORDING TO THE THERAPEUTIC APHERESIS: A PHYSICIAN¿S HANDBOOK; THE RATE OF ADVERSE EVENTS DURING THERAPEUTIC APHERESIS IS 4% TO 5%, WITH THE RISK BEING SLIGHTLY HIGHER DURING THE FIRST PROCEDURE, AND VARYING CONSIDERABLY WITH THE TYPE OF PROCEDURE. AMONG THE MOST COMMONLY PERFORMED PROCEDURES, THE RISK WAS HIGHER FOR THOSE INVOLVING ALLOGENEIC RED CELL OR PLASMA TRANSFUSION AND LOWER FOR PERIPHERAL BLOOD PROGENITOR CELL COLLECTION. WHEN COMPLICATIONS ARE AGGRESSIVELY MONITORED AND EXPECTED PHYSIOLOGIC RESPONSES AND MINOR REACTIONS ARE INCLUDED, ONE-THIRD OF TREATMENTS MAY BE NOTED TO INVOLVE SIDE EFFECTS. THE NUMBER OF COMPLICATIONS AND RATE OF COMPLICATIONS WERE SIGNIFICANTLY GREATER IN PATIENTS RECEIVING PLASMA AS THE REPLACEMENT FLUID RATHER THAN 3.3% ALBUMIN. ROOT CAUSE: A ROOT CAUSE ASSESSMENT WAS PERFORMED FOR THE ADVERSE REACTIONS. 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. THE REPORTED ADVERSE REACTIONS ARE COMMON SIDE EFFECTS OF THERAPEUTIC APHERESIS PROCEDURES. IN RELATION TO THE FEVER, BASED ON THE AVAILABLE INFORMATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED BUT IT IS LIKELY DUE TO ONE OR A COMBINATION OF THE POSSIBLE CAUSES LISTED BELOW:¿ PATIENT¿S REACTIONS TO THE MOBILIZATION REGIMEN¿ PATIENT¿S UNDERLYING DISEASE STATE¿ COMPLICATIONS ASSOCIATED WITH PROLONGED USE OF CATHETER ACCESS.¿ PATIENTS' UNDERLYING DISEASE DIAGNOSIS (IMMUNOCOMPROMISED HOST) AND/OR THE SPECIES WAS ENDOGENOUS AND ORIGINATED FROM THE PATIENT. A ROOT CAUSE ASSESSMENT WAS PERFORMED FOR THE HEMATOMAS. HEMATOMAS CAN RESULT FROM SEVERAL POTENTIAL ROOT CAUSES. THESE INCLUDE, BUT ARE NOT LIMITED TO : ¿ IMPROPER INSERTION TECHNIQUE: IF THE NEEDLE OR CATHETER IS INSERTED TOO QUICKLY, AT THE WRONG ANGLE, OR TOO FORCEFULLY, IT CAN DAMAGE THE BLOOD VESSELS, LEADING TO BLEEDING UNDER THE SKIN AND FORMING A HEMATOMA. INPROPER INSERTION TECHNIQUES CAN ALSO RESULT IN REPETITIVE PUNCTURES WHICH CAN ALSO CAUSE A HEMATOMA. ¿ VASCULAR TRAUMA: THE DEVICE COULD INADVERTENTLY PUNCTURE A BLOOD VESSEL, CAUSING BLOOD TO LEAK OUT INTO SURROUNDING TISSUE AND FORM A HEMATOMA. INAPPROPRIATE NEEDLE OR CATHETER SIZE: USING A NEEDLE OR CATHETER THAT IS TOO LARGE FOR THE INTENDED VEIN OR TISSUE CAN CAUSE SIGNIFICANT TRAUMA TO THE VESSEL WALLS, LEADING TO BLEEDING. ¿ PATIENT/DONOR DISEASE STATE/BLOOD PHYSIOLOGY; CERTAIN PATIENT CONDITIONS LIKE CLOTTING DISORDERS, ANTICOAGULANT THERAPY (E.G., WARFARIN OR HEPARIN), OR FRAGILE VEINS CAN INCREASE THE LIKELIHOOD OF HEMATOMA FORMATION. THE REPORTED HYPOTENSION IS A COMMON SIDE EFFECTS OF THERAPEUTIC APHERESIS PROCEDURES. THEY ARE TYPICALLY CAUSED BY THE PATIENT'S DISEASE STATE, THE RATE OF AC INFUSION, FLUID SHIFT, BLOOD LOSS, LENGTH OF THE PROCEDURE, PATIENT'S SENSITIVITY TO THE PROCEDURE AND/OR HEMODYNAMIC STRESS OF THE PROCEDURE. IN RELATION TO THE COAGULATION, THE EXACT CAUSE REMAINS UNDETERMINED. IT IS POSSIBLE THAT THE CLUMPING REPORTED DURING THIS PROCEDURE WAS RELATED TO THE PATIENT¿S INDIVIDUAL BLOOD PHYSIOLOGY AND/OR INADEQUATE ANTICOAGULATION OF THE EXTRACORPOREAL CIRCUIT. THE LIKELIHOOD FOR PLATELET CLUMPING TO OCCUR DURING A RUN IS DIFFICULT TO PREDICT SINCE IT IS NOT DEPENDENT ON A SPECIFIC PLATELET COUNT AND VARIES BY PATIENT. THEREFORE, EVERY PROCEDURE SHOULD BE OBSERVED FOR CLUMPING IN THE CONNECTOR. THE FOLLOWING ARE FURTHER POSSIBLE CAUSES OF CLOTTING WHICH COULD NOT BE RULED OUT AND INCLUDE: INCORRECT ENTRY OF PATIENT DATA INCLUDING HCT AND PLATELET COUNTS¿ POOR ACCESS RESULTING IN PUMP PAUSES¿ INCOMPLETE LOADING OF THE DISPOSABLE SET CAUSING AN OCCLUSION IN THE TUBING AND/OR AN AIR BLOCK, WHICH RESTRICTED THE FLOW¿ PATIENT'S BLOOD PHYSIOLOGY INTERFERES WITH SEPARATION OF CELLULAR COMPONENTS¿ RBC DETECTOR CONTAINED AN AIR BUBBLE¿ DEFECTIVE DISPOSABLE SET CITATION: HAUBNER, A., MENDOZA, S., WITT, V., DEEREN, D., BOJANIC, I., GASOVA, Z., GLATT, T. N., VASILACHE, A. M., NEWMAN, E., STRINEHOLM, V., & SKOSANA, Y. (2025B). REAL-WORLD SAFETY DATA FROM THE WORLD APHERESIS ASSOCIATION REGISTRY FOR THE SPECTRA OPTIA APHERESIS SYSTEM. JOURNAL OF CLINICAL APHERESIS, 40(6), E70079. HTTPS://DOI.ORG/10.1002/JCA.70079.
PER THE JOURNAL ARTICLE: "REAL-WORLD SAFETY DATA FROM THE WORLD APHERESIS ASSOCIATION REGISTRY FOR THE SPECTRA OPTIA APHERESIS SYSTEM" BY A. HAUBNER ET AL. IT WAS FOUND IN THIS STUDY WE ANALYZED 12 YEARS OF ADVERSE EVENTS, (AE) DATA FROM THE WORLD APHERESIS ASSOCIATION, (WAA) REGISTRY SPECIFIC TO THE SPECTRA OPTIA APHERESIS SYSTEM. WE QUERIED WAA REGISTRY DATA, (2012¿2023) ON APHERESIS PROCEDURES PERFORMED EXCLUSIVELY ON THE SPECTRA OPTIA APHERESIS SYSTEM. WE CATEGORIZED AES BY SEVERITY, (MILD, MODERATE, AND SEVERE), AND ORDERED THEM BY YEAR. WE THEN ANALYZED AND PRESENTED AES ASSOCIATED WITH THE FOLLOWING VARIABLES: DIAGNOSIS, PROCEDURE TYPE, VASCULAR ACCESS, AND REPLACEMENT FLUID TYPE, AND CAUSES OF PROCEDURAL INTERRUPTION. WE IDENTIFIED 51 567 APHERESIS PROCEDURES SPECIFIC TO THE SPECTRA OPTIA APHERESIS SYSTEM WITHIN THE DATA SET. AE RATES FROM 2012 TO 2023 FOR MILD, MODERATE, AND SEVERE WERE 1.43%, 2.81%, AND 0.21%, RESPECTIVELY. PROCEDURES ASSOCIATED WITH THE LOWEST AE RATES INCLUDE RED BLOOD CELL EXCHANGE AND THERAPEUTIC PLASMA EX CHANGE. THE MOST COMMON MILD AND MODERATE AES INCLUDE TINGLING AND HYPOTENSION AND AES RELATED TO VASCULAR ACCESS. THE HIGHEST RATES OF MILD AND MODERATE AES WERE ASSOCIATED WITH CELLULAR COLLECTIONS. THE HIGHEST RATE OF SEVERE AES WAS ASSOCIATED WITH THE USE OF 3.5% ALBUMIN AS REPLACEMENT FLUID. OTHER VARIABLES IMPACTING PATIENT SAFETY ARE IDENTIFIED. AE RATES COULD NOT BE COMPARED TO THE MEDIAN LENGTH OF PROCEDURE SINCE THIS TIME VARIABLE IS NOT CURRENTLY COLLECTED IN THE REGISTRY. THIS IS THE FIRST DEVICE-SPECIFIC ANALYSIS OF THE WAA REGISTRY DATA, BRINGING PRIOR SAFETY REPORTING INTO EVEN SHARPER FOCUS. DEVICE-SPECIFIC SAFETY ANALYSIS LIKE THIS WILL HELP PRACTITIONERS BETTER UNDERSTAND POTENTIAL SAFETY CONCERNS ASSOCIATED WITH A COMMONLY USED APHERESIS DEVICE, INCLUDING VARIOUS SEPARATION MODALITIES AND ACCESSORIES, THUS SUPPORTING IMPROVED PROCEDURE MANAGEMENT. THE AUTHORS IDENTIFIED THE FOLLOWING: "WE CALCULATED AN AVERAGE OF 1.43% MILD, 2.81% MODERATE, AND 0.21% SEVERE AE RATES FOR THE PERIOD ANALYZED. WITHIN THE DATA SET, WE NOTED ONE PATIENT DEATH WHERE THE IMPACT OF THE APHERESIS PROCEDURE COULD NOT HAVE BEEN RULED OUT. THIS CASE, DESCRIBED IN A PREVIOUS REPORT, WAS AN ELDERLY, SEVERELY ILL PATIENT, WHO DIED FROM MYOCARDIAL INFARCTION PROXIMATE TO THE APHERESIS PROCEDURE." THE COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER. 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. SPECIFIC DETAILS, SUCH AS PATIENT INFORMATION AND OUTCOME, WERE NOT INCLUDED IN THE ARTICLE FOR THESE EVENTS, THEREFORE THIS REPORT IS BEING PROVIDED AS A SUMMARY OF THE EVENTS. IT IS HIGHLY LIKELY THAT THESE SPECIFIC EVENTS WERE REPORTED TO AND FILED BY TERUMO BCT AS THIS STUDY WAS OVER THE COURSE OF A 12 YEAR PERIOD.
PER THE JOURNAL ARTICLE: "REAL-WORLD SAFETY DATA FROM THE WORLD APHERESIS ASSOCIATION REGISTRY FOR THE SPECTRA OPTIA APHERESIS SYSTEM" BY A. HAUBNER ET AL. IT WAS FOUND IN THIS STUDY WE ANALYZED 12 YEARS OF ADVERSE EVENTS, (AE) DATA FROM THE WORLD APHERESIS ASSOCIATION, (WAA) REGISTRY SPECIFIC TO THE SPECTRA OPTIA APHERESIS SYSTEM. WE QUERIED WAA REGISTRY DATA, (2012¿2023) ON APHERESIS PROCEDURES PERFORMED EXCLUSIVELY ON THE SPECTRA OPTIA APHERESIS SYSTEM. WE CATEGORIZED AES BY SEVERITY, (MILD, MODERATE, AND SEVERE), AND ORDERED THEM BY YEAR. WE THEN ANALYZED AND PRESENTED AES ASSOCIATED WITH THE FOLLOWING VARIABLES: DIAGNOSIS, PROCEDURE TYPE, VASCULAR ACCESS, AND REPLACEMENT FLUID TYPE, AND CAUSES OF PROCEDURAL INTERRUPTION. WE IDENTIFIED 51 567 APHERESIS PROCEDURES SPECIFIC TO THE SPECTRA OPTIA APHERESIS SYSTEM WITHIN THE DATA SET. AE RATES FROM 2012 TO 2023 FOR MILD, MODERATE, AND SEVERE WERE 1.43%, 2.81%, AND 0.21%, RESPECTIVELY. PROCEDURES ASSOCIATED WITH THE LOWEST AE RATES INCLUDE RED BLOOD CELL EXCHANGE AND THERAPEUTIC PLASMA EX CHANGE. THE MOST COMMON MILD AND MODERATE AES INCLUDE TINGLING AND HYPOTENSION AND AES RELATED TO VASCULAR ACCESS. THE HIGHEST RATES OF MILD AND MODERATE AES WERE ASSOCIATED WITH CELLULAR COLLECTIONS. THE HIGHEST RATE OF SEVERE AES WAS ASSOCIATED WITH THE USE OF 3.5% ALBUMIN AS REPLACEMENT FLUID. OTHER VARIABLES IMPACTING PATIENT SAFETY ARE IDENTIFIED. AE RATES COULD NOT BE COMPARED TO THE MEDIAN LENGTH OF PROCEDURE SINCE THIS TIME VARIABLE IS NOT CURRENTLY COLLECTED IN THE REGISTRY. THIS IS THE FIRST DEVICE-SPECIFIC ANALYSIS OF THE WAA REGISTRY DATA, BRINGING PRIOR SAFETY REPORTING INTO EVEN SHARPER FOCUS. DEVICE-SPECIFIC SAFETY ANALYSIS LIKE THIS WILL HELP PRACTITIONERS BETTER UNDERSTAND POTENTIAL SAFETY CONCERNS ASSOCIATED WITH A COMMONLY USED APHERESIS DEVICE, INCLUDING VARIOUS SEPARATION MODALITIES AND ACCESSORIES, THUS SUPPORTING IMPROVED PROCEDURE MANAGEMENT. THE AUTHORS IDENTIFIED THE FOLLOWING: "WE CALCULATED AN AVERAGE OF 1.43% MILD, 2.81% MODERATE, AND 0.21% SEVERE AE RATES FOR THE PERIOD ANALYZED. WITHIN THE DATA SET, WE NOTED ONE PATIENT DEATH WHERE THE IMPACT OF THE APHERESIS PROCEDURE COULD NOT HAVE BEEN RULED OUT. THIS CASE, DESCRIBED IN A PREVIOUS REPORT, WAS AN ELDERLY, SEVERELY ILL PATIENT, WHO DIED FROM MYOCARDIAL INFARCTION PROXIMATE TO THE APHERESIS PROCEDURE." THE COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER. 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. SPECIFIC DETAILS, SUCH AS PATIENT INFORMATION AND OUTCOME, WERE NOT INCLUDED IN THE ARTICLE FOR THESE EVENTS, THEREFORE THIS REPORT IS BEING PROVIDED AS A SUMMARY OF THE EVENTS. IT IS HIGHLY LIKELY THAT THESE SPECIFIC EVENTS WERE REPORTED TO AND FILED BY TERUMO BCT AS THIS STUDY WAS OVER THE COURSE OF A 12 YEAR PERIOD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 416934 | SPECTRA OPTIA | SPECTRA OPTIA EXCHANGE SET | LKN | TERUMO BCT | 05020583122208 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |