SPECTRA OPTIA
Report
- Report Number
- 1722028-2021-00035
- Event Type
- Injury
- Date Received
- January 26, 2021
- Date of Event
- May 8, 2020
- Report Date
- January 26, 2021
- Manufacturer
- TERUMO BCT
- Product Code
- LKN
- PMA / PMN Number
- K183081
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THIS REPORT IS BEING FILED TO PROVIDE ADDITIONAL INFORMATION IN B.5 AND H.10. INVESTIGATION: PER THE ARTICLE: ALL STANDARD RCE PROCEDURES WERE DONE USING THE COBE SPECTRA (VERSION 6.1 OR 7), WHEREAS ALL IHD-RCE PROCEDURES WERE DONE WITH THE SPECTRA OPTIA (VERSION 11.3) AND USED NORMAL SALINE AS THE IHD REPLACEMENT FLUID. AFTER INITIAL DETERMINATION OF THE REQUIRED RBC VOLUME TO ACHIEVE TARGET HCT AND FRACTION OF CELLS REMAINING (FCR%) VALUES, PROCEDURES WERE PROGRAMMED BY INPUTTING THE TARGET HCT, THE ESTIMATED RBC VOLUME, AND A REPLACEMENT FLUID HCT OF 55%; RBC VOLUME WAS THEN ADJUSTED PER PERIODIC REVIEW OF ACTUAL HCT AND HBS% VALUES. FOR IHD-RCE PROCEDURES, TARGET MINIMUM (POST HEMODILUTION) AND POST PROCEDURE HCT WERE BASED ON PREPROCEDURE HCT AS PER PUBLISHED PROTOCOL. THE MEAN TARGET HCT FOR RCE PROCEDURES WAS 31% ± 1% AND FOR IHD-RCE PROCEDURES WAS 32% ± 1%. FOR BOTH PROCEDURE TYPES, STANDARD ANTICOAGULANT INFUSION RATES AND INLET:ANTICOAGULANT RATIOS OF 0.8-0.9 ML/MIN/L TBV AND 13:1, RESPECTIVELY WERE USED. ALL RBC UNITS WERE ADDITIVE SOLUTION FORMULA 3, LEUKOREDUCED, LESS THAN 15 DAYS OLD WHEN POSSIBLE, AND MATCHED FOR C, E, AND KELL ANTIGENS AS WELL AS ANY ALLOANTIBODIES. FOR PATIENT 4, DUE TO REPEATED ALLERGIC REACTIONS, UNITS WERE WASHED STARTING FROM THE LAST SEVEN STANDARD RCE PROCEDURES THROUGH ALL 35 IHD-RCE PROCEDURES. IN REGARD TO THE SAFETY OF THE MINIMUM HCT, THE MEAN PROGRAMMED MINIMUM HCT WAS 24.7%, WITH THE LOWEST INDIVIDUAL VALUE BEING 20%; THE MEAN HCT DECREASE WAS 22%, WITH THE HIGHEST INDIVIDUAL VALUE BEING 26%; AND THE MEAN ABSOLUTE HCT DECREASE WAS 7.1%, WITH THE LARGEST INDIVIDUAL VALUE BEING 8.4%. AT COMPLETION OF THE IHD PHASE OF IHD-RCE, FIVE OF SIX PATIENTS HAD STATISTICALLY SIGNIFICANT DROPS IN SYSTOLIC AND DIASTOLIC BLOOD PRESSURE (BP), WHICH IN SOME PATIENTS REMAINED STATISTICALLY SIGNIFICANT IMMEDIATELY FOLLOWING THE PROCEDURE (FIGURE 1A). ALTHOUGH SUCH DROPS COULD POTENTIALLY INCREASE STROKE RISK,6 MEAN DROPS WERE LESS THAN 15% AND TYPICALLY LESS THAN 10%. FURTHERMORE, COMPENSATORY INCREASES IN HEART RATE FOLLOWING IHD WERE NOT STATISTICALLY SIGNIFICANT, AND ONLY ONE PATIENT (PATIENT 5) HAD A STATISTICALLY SIGNIFICANT, MILD INCREASE IN HEART RATE AFTER THE PROCEDURE. REPEATED MEASURES ANALYSIS SHOWED NO CLINICALLY SIGNIFICANT INFLUENCE OF PROCEDURE NUMBER ON THE MEASURED VARIABLES. RESULTS: THERE WERE STATISTICALLY BUT NOT CLINICALLY SIGNIFICANT DROPS IN BLOOD PRESSURE IN THE POST-IHD PHASE. WITH IHD-RCE, THERE WERE SIGNIFICANT REDUCTIONS IN RED BLOOD CELL (RBC) USAGE AND/OR LOWER FRACTION OF CELLS AND SIGNIFICANT INCREASES IN POSTPROCEDURE HEMATOCRIT (HCT) ASSOCIATED WITH INCREASED PREPROCEDURE HCT. THERE WERE NO DIFFERENCES ACHIEVED IN THE TIME INTERVAL BETWEEN PROCEDURES OR IN THE NET RBC GAIN WITH IHD-RCE. OVERALL, THERE WERE ALSO NO SIGNIFICANT DIFFERENCES IN PRE- AND POSTPROCEDURE PERCENTAGE OF HEMOGLOBIN S, RETICULOCYTE COUNT, INTERVAL DAILY HEMOGLOBIN A DECREMENT, OR POST PROCEDURE WHITE BLOOD CELL, NEUTROPHIL, OR PLATELET COUNTS. 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. 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. ACCORDING TO THE AABB CIRCULAR OF INFORMATION FOR THE USE OF HUMAN BLOOD COMPONENTS (REVISED 2017), ALLERGIC REACTIONS FREQUENTLY OCCUR (IE, 1-3% OF PLASMA-CONTAINING COMPONENTS) AS MILD OR SELF-LIMITING URTICARIA OR WHEEZING THAT USUALLY RESPOND TO ANTIHISTAMINES. MORE SEVERE MANIFESTATIONS, INCLUDING RESPIRATORY AND CARDIOVASCULAR SYMPTOMS, ARE MORE CONSISTENT WITH ANAPHYLACTOID/ANAPHYLACTIC REACTIONS AND MAY REQUIRE MORE AGGRESSIVE THERAPY (SEE BELOW). NO LABORATORY PROCEDURES ARE AVAILABLE TO PREDICT THESE REACTIONS. ANAPHYLACTIC REACTIONS, CHARACTERIZED BY HYPOTENSION, TACHYCARDIA, NAUSEA, VOMITING AND/OR DIARRHEA, ABDOMINAL PAIN, SEVERE DYSPNEA, PULMONARY AND/OR LARYNGEAL EDEMA, AND BRONCHOSPASM AND/OR LARYNGOSPASM, ARE RARE (<10/100,000 TRANSFUSED UNITS) BUT DANGEROUS COMPLICATIONS REQUIRING IMMEDIATE TREATMENT WITH EPINEPHRINE. WHILE THESE REACTIONS HAVE BEEN REPORTED IN IGA-DEFICIENT PATIENTS WITH ANTI-IGA ANTIBODIES AND PATIENTS WITH HAPTOGLOBIN DEFICIENCY, MOST REACTIONS ARE IDIOSYNCRATIC AND NOT ASSOCIATED WITH A SPECIFIC SERUM PROTEIN DEFICIENCY, POLYMORPHISM, OR IDENTIFIABLE CAUSE. DHR DETAILS: SINCE THIS IS A RETROSPECTIVE CROSSOVER ANALYSIS OF SIX PATIENTS WITH SCD WHO UNDERWENT CHRONIC EXCHANGE WITH STANDARD RCE (COBE SPECTRA) FOLLOWED BY IHD-RCE (SPECTRA OPTIA), THE LOT NUMBERS WERE NOT PROVIDED; THEREFORE, A DHR SEARCH COULD NOT BE CONDUCTED FOR THIS SPECIFIC INCIDENT. ALL LOTS MUST MEET ACCEPTANCE CRITERIA FOR RELEASE. THIS PRODUCT HAS BEEN PROCESSED WITH ETO TO ACHIEVE A 10-6 STERILITY ASSURANCE LEVEL IN ACCORDANCE WITH EN ISO 11135. THIS PRODUCT HAS BEEN VALIDATED TO ACHIEVE LESS THAN 6MG ETO, MEETING THE REQUIREMENTS OF ISO 10993-7 PRIOR TO RELEASE AND LESS THEN 1PPM IN THE COLLECT BAG AT TIME OF USE. INVESTIGATION IS IN PROCESS. A FOLLOW UP REPORT WILL BE PROVIDED.
THIS RECORD IS BEING FILED TO PROVIDE ADDITIONAL INFORMATION IN H.6 AND H.10. INVESTIGATION: THE STUDY OF SIX PATIENTS UNDERGOING OPTIA IHD-RCE PROCEDURES ADDS UNIQUE VALUE AS A CROSSOVER ANALYSIS, WITH THEIR PRIOR STANDARD RCES SERVING AS CONTROLS. ALSO, SINCE NORMAL SALINE REPLACEMENT IS USED, OUR STUDY PROVIDES ADDITIONAL SAFETY DATA ON POTENTIALLY HIGHER-RISK NORMAL SALINE (VS ALBUMIN) REPLACEMENT. THIRDLY, IHD-RCE PROCEDURES ON THE OPTIA IN PATIENTS WITH PREVIOUS STROKE HAS BEEN HERETOFORE REPORTED IN A TOTAL OF ONLY FOUR PATIENTS WITH SCD; THUS, OUR FINDINGS IN THREE PATIENTS WITH HISTORY OF STROKE SIGNIFICANTLY EXPANDS AVAILABLE DATA. FINALLY, NO STUDY HAS HERETOFORE REPORTED ON BRAIN MAGNETIC RESONANCE IMAGING (MRI) RESULTS FOLLOWING A PERIOD OF IHDRCE USAGE, AND OUR STUDY UNIQUELY REPORTS ON FOLLOW-UP BRAIN MRIS, WHEN AVAILABLE, TO ASCERTAIN OCCURRENCE OR PROGRESSION OF SILENT INFARCTS. THIS IS CRITICAL BECAUSE PATIENTS WITH SCD ARE STILL AT RISK FOR RECURRENT OR PROGRESSIVE INFARCTION DESPITE CHRONIC TRANSFUSION. ALL SIX PATIENTS FROM COHEN CHILDREN'S MEDICAL CENTER WHO CROSSED OVER FROM STANDARD RCE TO IHD-RCE WERE INCLUDED IN THE ANALYSIS. ALL DONORS TRANSITIONED BETWEEN (B)(6) 2015 AND (B)(6) 2016. PATIENT CHARACTERISTICS ARE DESCRIBED IN TABLE 1. OF THE SIX PATIENTS, FIVE HAD HBSS AND ONE HAD SB+ THALASSEMIA. ALL SIX WERE BLACK; THREE WERE MALE AND THREE WERE FEMALE. MEAN PATIENT AGE AT THE TIME OF FIRST IHD-RCE WAS 15.4 ± 2.0 YEARS. THE INDICATION FOR RCE WAS STROKE PROPHYLAXIS IN FOUR, THREE OF WHOM HAD MOYAMOYA DISEASE, AND TWO OF WHOM HAD FREQUENT VASO-OCCLUSIVE CRISIS (VOC). ROOT CAUSE: A DEFINITIVE ROOT CAUSE OF THE ALLEGED ALLERGIC REACTION COULD NOT BE DETERMINED. POSSIBLE CAUSES INCLUDE BUT ARE NOT LIMITED TO: - PATIENT SENSITIVITY TO THE REPLACEMENT RBCS - PATIENT SENSITIVITY TO THE ETHYLENE OXIDE USED TO STERILIZE THE DISPOSABLE SET.
THIS IS A RETROSPECTIVE CROSSOVER ANALYSIS OF SIX PATIENTS WITH SCD WHO UNDERWENT CHRONIC EXCHANGE WITH STANDARD RCE (COBE SPECTRA) FOLLOWED BY IHD-RCE (SPECTRA OPTIA). A REQUEST FOR SPECIFIC PATIENT INFORMATION IS NOT FEASIBLE.
LOT NUMBER AND EXPIRY INFORMATION ARE NOT AVAILABLE AT THIS TIME. INVESTIGATION: THE AUTHORS CONCLUDED, "IHD-RCE DID NOT RESULT IN CLINICALLY EVIDENT ADVERSE EVENTS AND HAD SIGNIFICANT BENEFITS OF DECREASED RBC USAGE AND/OR FCR% AND INCREASED POSTPROCEDURE HCT ASSOCIATED WITH INCREASED PREPROCEDURE HCT. THESE CONSIDERATIONS ARE CRITICAL, ESPECIALLY IN SITUATIONS OF DECREASED AVAILABILITY OF UNITS FROM MINORITY DONORS, AS IN THE CURRENT COVID-19 PANDEMIC, AND A MINORITY OF INSTITUTIONS HAVING IMPLEMENTED REDUCTION-EXCHANGE PROCEDURES." REFERENCE: Y ZIEMBA, C XU, KM FOMANI, V NANDI, T YUAN, S REHMANI, BS SACHAIS, AO APPIAH-KUBI, B AYGUN, JE LOUIE, PA SHI. SAFETY AND BENEFITS OF AUTOMATED RED CELL REDUCTION-EXCHANGE COMPARED TO STANDARD EXCHANGE IN PATIENTS WITH SICKLE CELL DISEASE UNDERGOING CHRONIC TRANSFUSION.. TRANSFUSION. 2020. INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.
ACCORDING TO THE ARTICLE, "SAFETY AND BENEFITS OF AUTOMATED RED CELL REDUCTION-EXCHANGE COMPARED TO STANDARD EXCHANGE IN PATIENTS WITH SICKLE CELL DISEASE UNDERGOING CHRONIC TRANSFUSION", A RETROSPECTIVE CROSSOVER ANALYSIS OF SIX PATIENTS WITH SICKLE CELL DISEASE (SCD) WHO UNDERWENT CHRONIC RED BLOOD CELL EXCHANGE (RCE) WITH STANDARD RCE (COBE SPECTRA) FOLLOWED BY ISOVOLEMIC HEMODILUTION (IHD) IHD-RCE (SPECTRA OPTIA), THE AUTHORS COMPARED SAFETY AND BENEFIT OUTCOMES WITH IHD-RCE VS STANDARD RCE. ALL STANDARD RCE PROCEDURES WERE DONE USING THE COBE SPECTRA (VERSION 6.1 OR 7), WHEREAS ALL IHD-RCE PROCEDURES WERE DONE WITH THE SPECTRA OPTIA (VERSION 11.3) AND USED NORMAL SALINE AS THE IHD REPLACEMENT FLUID. ADVERSE EVENTS: THE AUTHORS NOTED NO CLINICALLY SIGNIFICANT DIFFERENCES ATTRIBUTABLE TO RCE TYPE. RBC ALLOANTIBODY FORMATION DID NOT APPEAR INCREASED WITH IHD-RCE COMPARED TO STANDARD RCE. NO PATIENT EXPERIENCED ANY ACUTE FOCAL NEUROLOGIC DEFICITS OR TRANSIENT ISCHEMIC ATTACKS DURING EITHER RCE PERIOD. FOLLOW-UP BRAIN MRI/MAGNETIC RESONANCE ANGIOGRAPHIES (MRAS) ON IHD-RCE WERE OBTAINED ON ALL PATIENTS WHO WERE PUT ON EXCHANGE FOR STROKE PROPHYLAXIS; THERE WAS NO CLEAR EVIDENCE OF STROKE PROGRESSION ON IHD-RCE IN ANY PATIENT. ADDITIONALLY, THE AUTHORS NOTED A STATISTICAL DIFFERENCE IN BLOOD PRESSURE. AT COMPLETION OF THE IHD PHASE OF IHD-RCE, FIVE OF SIX PATIENTS HAD STATISTICALLY SIGNIFICANT DROPS IN SYSTOLIC AND DIASTOLIC BLOOD PRESSURE (BP), WHICH IN SOME PATIENTS REMAINED STATISTICALLY SIGNIFICANT IMMEDIATELY FOLLOWING THE PROCEDURE. THE AUTHORS NOTE THAT ALTHOUGH SUCH DROPS COULD POTENTIALLY INCREASE STROKE RISK, MEAN DROPS WERE LESS THAN 15% AND TYPICALLY LESS THAN 10%. FURTHERMORE, COMPENSATORY INCREASES IN HEART RATE FOLLOWING IHD WERE NOT STATISTICALLY SIGNIFICANT, AND ONLY ONE PATIENT HAD A STATISTICALLY SIGNIFICANT, MILD INCREASE IN HEART RATE AFTER THE PROCEDURE. THIS REPORT IS FOR PATIENT 2, WHO UNDERWENT 38 IHD-RCE PROCEDURES. THIS PATIENT EXPERIENCED 2 ALLERGIC REACTIONS. PROCEDURE DETAILS, INCLUDING IF ANY MEDICAL INTERVENTION WAS NEEDED FOR THE ALLERGIC REACTION AND PATIENT OUTCOME WERE NOT PROVIDED IN THE ARTICLE, THEREFORE, THIS REPORT IS BEING PROVIDED AS A SUMMARY OF EVENTS. PATIENT WEIGHT WAS NOT PROVIDED IN THE ARTICLE. 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 |
|---|---|---|---|---|---|---|---|
| 125883 | SPECTRA OPTIA | SPECTRA OPTIA EXCHANGE SET, EA | LKN | TERUMO BCT |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00017 YR | Male | Other |