SPECTRA OPTIA
Report
- Report Number
- 1722028-2022-00063
- Event Type
- Injury
- Date Received
- February 25, 2022
- Date of Event
- December 23, 2021
- Report Date
- February 25, 2022
- Manufacturer
- TERUMO BCT
- Product Code
- LKN
- UDI-DI
- 05020583102200
- PMA / PMN Number
- K183081
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
LOT NUMBER AND EXPIRY INFORMATION ARE NOT AVAILABLE AT THIS TIME. ARTICLE CITATION: HEQUET O, BOISSON C, JOLY P, REVESZ D, KEBAILI K, GAUTHIER A, RENOUX C, CREPPY S, NADER E, NICOLAS JF, BERARD F, COGNASSE F, VOCANSON M, BERTRAND Y AND CONNES P (2021) PRIMING WITH RED BLOOD CELLS ALLOWS RED BLOOD CELL EXCHANGE FOR SICKLE CELL DISEASE IN LOW-WEIGHT CHILDREN. FRONT. MED. 8:743483. DOI: 10.3389/FMED.2021.743483 INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.
LOT NUMBER AND EXPIRY INFORMATION ARE NOT AVAILABLE AT THIS TIME. ARTICLE CITATION: HEQUET O, BOISSON C, JOLY P, REVESZ D, KEBAILI K, GAUTHIER A, RENOUX C, CREPPY S, NADER E, NICOLAS JF, BERARD F, COGNASSE F, VOCANSON M, BERTRAND Y AND CONNES P (2021) PRIMING WITH RED BLOOD CELLS ALLOWS RED BLOOD CELL EXCHANGE FOR SICKLE CELL DISEASE IN LOW-WEIGHT CHILDREN. FRONT. MED. 8:743483. DOI: 10.3389/FMED.2021.743483 INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.
INVESTIGATION: SINCE THIS WAS A JOURNAL PUBLICATION TO PROSPECTIVELY ANALYZE THE CLINICAL SAFETY OF THE RCE/RBC-PRIMED PROCEDURE IN 12 SCA LOW-WEIGHT CHILDREN UNDER EITHER A CHRONIC RCE PROGRAM OR EMERGENCY TREATMENT OVER 65 SESSIONS, THE DISPOSABLE SETS WERE NOT REQUESTED FOR RETURN. THIS PROSPECTIVE STUDY AIMED TO ASSESS THE FEASIBILITY AND SAFETY OF AUTOMATIC PRIMING USING RED BLOOD CELLS (RBCS) (RCE/RBC-PRIMED) USING SPECTRA OPTIA IN PEDIATRIC PATIENTS (N = 12) WITH LOW WEIGHT AND SICKLE CELL ANEMIA. RED BLOOD CELL EXCHANGE SESSIONS WERE PERFORMED EVERY 6 WEEKS. IN CHRONIC PROGRAMS, RCE SESSIONS WERE PERFORMED EVERY 6 WEEKS. OTHERWISE, RCE SESSIONS WERE PERFORMED WHEN AN ACUTE SCA COMPLICATION OCCURRED. VENOUS ACCESS WAS SHORT-TERM CENTRAL VENOUS ACCESS IN ALL CASES. IRREGULAR AGGLUTININ RESEARCH WAS PERFORMED BEFORE RCE SESSIONS. TRANSFUSED RBC UNITS (RBCUS) WERE SICKLE-NEGATIVE, LEUCO-REDUCED, CROSSMATCH-COMPATIBLE, AND PHENOTYPICALLY MATCHED FOR THE C, E, C, E, AND K (JK2 AND MNS3 WHEN POSSIBLE) ANTIGENS. ALL THE RBCUS TRANSFUSED WERE HEATED TO 37¿C IN A WATER BATH. CONSIDERING THE LOW WEIGHT OF THE CHILDREN, THE TBV WAS CALCULATED USING THE INITIAL AND SIMPLIFIED FORMULAE OF GLICHER: TBV (ML) = WEIGHT (KG) × 75 (17). THE NUMBER OF RBCUS NEEDED CAN EASILY BE DEDUCED SINCE THE SPECTRA OPTIA R SOFTWARE (VERSION 7.2) CALCULATES THE VOLUME OF TRANSFUSED RBCS REQUIRED TO REACH THE PREDICTIVE FRACTION OF CELL REMAINING (PFCR) AND THE PREDICTIVE HCT (PHCT). TO PERFORM RBC PRIMING, A SUPPLEMENTARY COMPATIBLE RBCU (CALLED RECONSTITUTED RBCU) WAS ORDERED AND COMPLETED WITH ABO-COMPATIBLE FRESH FROZEN PLASMA TO OBTAIN A RECONSTITUTED RBCU. TO PREVENT HEMOCONCENTRATION DURING THE CRITICAL SESSION STAGE, I.E., AFTER INFUSION OF 185ML OF CONCENTRATED RBCS WHILE THE DEVICE HAS NOT REMOVED SIGNIFICANT AMOUNTS OF ABNORMAL RBCS, WE PRIMED THE CIRCUIT WITH RBCU DILUTED WITH ABO-COMPATIBLE FRESH FROZEN PLASMA TARGETING ANHCT CLOSE TO THE BLOOD LEVEL OF THE PATIENT, I.E., WITH AN HCT OF 28%, BASED ON OUR CLINICAL EXPERIENCE. AFTER DISCONTINUATION OF THE PRIMING CIRCUIT (VOLUME 200ML AND FLOW 60 ML/MIN), THE RECONSTITUTED RBCU WAS REMOVED, AND THE RBC-PRIMED CIRCUIT WAS CONNECTED TO THE CENTRAL VENOUS ACCESS. DEPENDING ON THE DEGREE OF FILLING OF THE INFUSION CHAMBER, THE EV OF THE RCE FOR THE SPECTRA OPTIA R (TERUMO BCT) DEVICE CIRCUIT RANGES FROM 141 TO 185ML (14), AND THE LATTER VALUE WAS CHOSEN FOR FURTHER CALCULATIONS. SINCE RINSE-BACK IS NOT RECOMMENDED AT THE END OF THE RCE IN CHILDREN (15), 15 ML/KG OF 4% ALBUMIN WAS CONTINUOUSLY PERFUSED TO PREVENT HYPOVOLEMIA AT THE END OF THE PROCEDURE. ANTICOAGULATION OF THE CIRCUIT WAS PERFORMED USING ACID CITRATE DEXTROSE SOLUTION A (ACD-A), AND A SIGNIFICANT DECREASE IN BLOOD CALCIUM CONCENTRATION WAS PREVENTED BY CONTINUOUS INTRAVENOUS CALCIUM INFUSION. THE CLINICAL TOLERANCE OF RCE USING RCE/RBC-PRIMED IN LOWWEIGHT CHILDREN WAS DIVIDED INTO THREE PERIODS: DURING THE FIRST 10MIN OF THE RCE/RBC-PRIMED SESSIONS, CORRESPONDING TO THE TIME BETWEEN THE BLOOD INTAKE OF THE PATIENT AND THE INFUSION OF NORMAL RBCS (CALLED THE CRITICAL TIME OF PRIMING REINFUSION), AND DURING TWO CONSECUTIVE 40-MIN PERIODS. SYSTOLIC BP AND HEART RATE (HR) WERE MONITORED EVERY 2MIN DURING THE CRITICAL TIME OF PRIMING REINFUSION AND EVERY 10MIN DURING THE REMAINING SESSION. ACCORDING TO THE NATIONAL CANCER INSTITUTE COMMON TERMINOLOGY CRITERIA FOR ADVERSE EVENTS GUIDELINES (18), GRADE 2 AES OR HIGHER CORRESPOND TO A SIGNIFICANT DECREASE IN SBP (>20 MMHG) AND A SIGNIFICANT INCREASE IN HR (>20 PULSES PER MINUTE) ASSOCIATED OR NOT WITH A SIGNIFICANT FAINTING/ASTHENIA SENSATION. THE NUMBER OF RCE/RBC-PRIMED SESSIONS WITH GRADE 2 AES OR HIGHER WERE RECORDED, AS WELL AS THE SYMPTOMS OF TRANSFUSION-RELATED AES (PRURITUS, URTICARIAL ERYTHEMATOUS WHEALS, SKIN EDEMA, AND WHEEZING). AT THE END OF THE RCE SESSIONS, POST-APHERESIS HCT WAS ASSESSED TO OBTAIN ACTUAL HCT (AHCT). IN PARALLEL, THE POSTAPHERESIS PERCENTAGE OF HBS (ACTUAL HBS OR AHBS) WAS ASSESSED TO CALCULATE ACTUAL FCR (AFCR). THE AFCR WAS CALCULATED AS FOLLOWS: AFCR = AHBS)/PRE-APHERESIS HBS (ALSO CALLED NATIVE HBS OR NHBS). WE ALSO NOTED THE PREDICTIVE FCR (PFCR) WHICH IS RECORDED ON THE DEVICE BEFORE THE SESSIONS AND THE FINAL FCR (FFCR), WHICH CORRESPONDS TO THE FCR RECORDED BY THE DEVICE AT THE END OF THE SESSIONS. IN PARALLEL, WE NOTED PRE-APHERESIS OR NATIVE HCT (NHCT), PREDICTIVE HCT (PHCT, RECORDED ON THE DEVICE BEFORE THE SESSION), AND FINAL HCT (FHCT, RECORDED ON THE DEVICE AT THE END OF THE SESSIONS). CHANGES IN FACTORS PRONE TO INFLUENCE HEMOSTASIS PARAMETERS WERE ASSESSED, I.E., RATIO OF ACD-A/CALCIUM INFUSED AND DECREASE IN PLATELET BLOOD LEVELS (CALCULATED AS FOLLOWS: DECREASE IN PLATELET LEVEL = [PRE-APHERESIS BLOOD LEVEL ¿ POST-APHERESIS BLOOD LEVEL]/PRE-APHERESIS BLOOD LEVEL). CLINICAL COMPLICATIONS DURING THE 65 RCE/RBC-PRIMED SESSIONS INCLUDED 2 EPISODES OF A DECREASE IN SYSTOLIC BLOOD PRESSURE IN 2 PATIENTS, 2 EPISODES OF AN INCREASE IN HEART RATE IN 2 PATIENTS, AND 3 EPISODES OF FAINTING SENSATION IN 2 PATIENTS. ALL COMPLICATIONS OCCURRED DURING THE LAST 30 MIN OR IN THE FIRST 5 MIN AFTER THE END OF THE SESSION (TABLE 2). SYSTOLIC BLOOD PRESSURE (SBP) DECREASED IN TWO PATIENTS JUST AFTER THE END OF THE SESSIONS (TABLE 2). ONE EPISODE OF A SIGNIFICANT INCREASE IN HEART RATE OCCURRED IN TWO PATIENTS AND A FAINTING SENSATION OCCURRED DURING THREE SESSIONS IN TWO CHILDREN, ALL DURING THE LAST 30 MIN. SALINE AND 4% ALBUMIN WERE INFUSED, INDUCING A DECREASE IN HR OR FAINTING SENSATION (WHILE RCE CONTINUED) AND A RAPID INCREASE IN SBP. ALL THE HEMODYNAMIC COMPLICATIONS OCCURRED AT THE END OF THE RCE SESSIONS. THE OCCURRENCE OF AES AT THIS TIME SUGGESTED A ROLE OF THE LARGE VOLUME OF RBC EXCHANGED (MORE THAN 80% OF RBC EXCHANGED I.E., AFCR < 20%) AND WE COULD SPECULATE THAT EXCHANGING LOWER AMOUNTS OF RBC MAY DECREASE THE INCIDENCE OF AES. NO PRURITUS OR URTICARIAL WHEALS AND NO WHEEZING WERE OBSERVED THEREAFTER DURING THE ENTIRE PROTOCOL (TABLE 2). AUTHORS ATTRIBUTED THE COMPLICATIONS TO THE LARGE VOLUME OF RED BLOOD CELLS EXCHANGED. RESULTS ARE REPORTED ON PAGES 3 AND 4 AND IN TABLE 2. THE AUTHORS CONCLUDED ¿THE USAGE OF RBC-PRIMING IN LOW-WEIGHT CHILDREN APPEARS NECESSARY AND SAFE WHEN PERFORMING RCE. RBC-PRIMING DID NOT MODIFY THE PERFORMANCES OF RCE. ALTOGETHER, THESE RESULTS SHOULD ENCOURAGE APHERESIS AND PEDIATRIC HEMATOLOGICAL TEAMS TO PERFORM RCE IN THESE LOW WEIGHT CHILDREN WHILE CONSIDERING MANY PRECAUTIONS.¿ SINCE THIS WAS A JOURNAL PUBLICATION TO PROSPECTIVELY ANALYZE THE CLINICAL SAFETY OF THE RCE/RBC-PRIMED PROCEDURE IN 12 SCA LOW-WEIGHT CHILDREN UNDER EITHER A CHRONIC RCE PROGRAM OR EMERGENCY TREATMENT OVER 65 SESSIONS, THE LOT NUMBERS WERE NOT REQUESTED; THEREFORE, A DISPOSABLE LOT HISTORY SEARCH COULD NOT BE CONDUCTED. 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. VASOVAGAL INCIDENTS OCCUR AROUND 0.5% 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. ROOT CAUSE: A ROOT CAUSE ASSESSMENT FOR THE ADVERSE PATIENT REACTIONS WAS PERFORMED FOR THIS COMPLAINT. THE REPORTED ADVERSE REACTIONS ARE 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. ARTICLE CITATION: HEQUET O, BOISSON C, JOLY P, REVESZ D, KEBAILI K, GAUTHIER A, RENOUX C, CREPPY S, NADER E, NICOLAS JF, BERARD F, COGNASSE F, VOCANSON M, BERTRAND Y AND CONNES P (2021) PRIMING WITH RED BLOOD CELLS ALLOWS RED BLOOD CELL EXCHANGE FOR SICKLE CELL DISEASE IN LOW-WEIGHT CHILDREN. FRONT. MED. 8:743483. DOI: 10.3389/FMED.2021.743483.
THE JOURNAL ARTICLE, "PRIMING WITH RED BLOOD CELLS ALLOWS RED BLOOD CELL EXCHANGE FOR SICKLE CELL DISEASE IN LOW-WEIGHT CHILDREN" BY HEQUET ET AL IS A PROSPECTIVE STUDY AIMED TO ASSESS THE FEASIBILITY AND SAFETY OF AUTOMATIC PRIMING USING RED BLOOD CELLS (RBCS) (RCE/RBC-PRIMED) USING SPECTRA OPTIA IN PEDIATRIC PATIENTS (N = 12) WITH LOW WEIGHT AND SICKLE CELL ANEMIA. RED BLOOD CELL EXCHANGE SESSIONS WERE PERFORMED EVERY 6 WEEKS. CLINICAL COMPLICATIONS DURING THE 65 RCE/RBC-PRIMED SESSIONS INCLUDED 2 EPISODES OF A DECREASE IN SYSTOLIC BLOOD PRESSURE IN 2 PATIENTS, 2 EPISODES OF AN INCREASE IN HEART RATE IN 2 PATIENTS, AND 3 EPISODES OF FAINTING SENSATION IN 2 PATIENTS. SALINE AND 4% ALBUMIN WERE INFUSED, INDUCING A DECREASE IN HR OR FAINTING SENSATION (WHILE RCE CONTINUED) AND A RAPID INCREASE IN SBP. ALL THE HEMODYNAMIC COMPLICATIONS OCCURRED AT THE END OF THE RCE SESSIONS. AUTHORS ATTRIBUTED THE COMPLICATIONS TO THE LARGE VOLUME OF RED BLOOD CELLS EXCHANGED. RESULTS ARE REPORTED ON PAGES 3 AND 4 AND IN TABLE 2. THE AUTHORS CONCLUDED ¿THE USAGE OF RBC-PRIMING IN LOW-WEIGHT CHILDREN APPEARS NECESSARY AND SAFE WHEN PERFORMING RCE. RBC-PRIMING DID NOT MODIFY THE PERFORMANCES OF RCE. ALTOGETHER, THESE RESULTS SHOULD ENCOURAGE APHERESIS AND PEDIATRIC HEMATOLOGICAL TEAMS TO PERFORM RCE IN THESE LOW WEIGHT CHILDREN WHILE CONSIDERING MANY PRECAUTIONS.¿ 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 UNKNOWN THAT THIS TIME IF MEDICAL INTERVENTION WAS REQUIRED FOR THESE EVENTS. THE DISPOSABLE SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.
THE JOURNAL ARTICLE, "PRIMING WITH RED BLOOD CELLS ALLOWS RED BLOOD CELL EXCHANGE FOR SICKLE CELL DISEASE IN LOW-WEIGHT CHILDREN" BY HEQUET ET AL IS A PROSPECTIVE STUDY AIMED TO ASSESS THE FEASIBILITY AND SAFETY OF AUTOMATIC PRIMING USING RED BLOOD CELLS (RBCS) (RCE/RBC-PRIMED) USING SPECTRA OPTIA IN PEDIATRIC PATIENTS (N = 12) WITH LOW WEIGHT AND SICKLE CELL ANEMIA. RED BLOOD CELL EXCHANGE SESSIONS WERE PERFORMED EVERY 6 WEEKS. CLINICAL COMPLICATIONS DURING THE 65 RCE/RBC-PRIMED SESSIONS INCLUDED 2 EPISODES OF A DECREASE IN SYSTOLIC BLOOD PRESSURE IN 2 PATIENTS, 2 EPISODES OF AN INCREASE IN HEART RATE IN 2 PATIENTS, AND 3 EPISODES OF FAINTING SENSATION IN 2 PATIENTS. SALINE AND 4% ALBUMIN WERE INFUSED, INDUCING A DECREASE IN HR OR FAINTING SENSATION (WHILE RCE CONTINUED) AND A RAPID INCREASE IN SBP. ALL THE HEMODYNAMIC COMPLICATIONS OCCURRED AT THE END OF THE RCE SESSIONS. AUTHORS ATTRIBUTED THE COMPLICATIONS TO THE LARGE VOLUME OF RED BLOOD CELLS EXCHANGED. RESULTS ARE REPORTED ON PAGES 3 AND 4 AND IN TABLE 2. THE AUTHORS CONCLUDED ¿THE USAGE OF RBC-PRIMING IN LOW-WEIGHT CHILDREN APPEARS NECESSARY AND SAFE WHEN PERFORMING RCE. RBC-PRIMING DID NOT MODIFY THE PERFORMANCES OF RCE. ALTOGETHER, THESE RESULTS SHOULD ENCOURAGE APHERESIS AND PEDIATRIC HEMATOLOGICAL TEAMS TO PERFORM RCE IN THESE LOW WEIGHT CHILDREN WHILE CONSIDERING MANY PRECAUTIONS.¿ 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 UNKNOWN THAT THIS TIME IF MEDICAL INTERVENTION WAS REQUIRED FOR THESE EVENTS. THE DISPOSABLE SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.
THE JOURNAL ARTICLE, "PRIMING WITH RED BLOOD CELLS ALLOWS RED BLOOD CELL EXCHANGE FOR SICKLE CELL DISEASE IN LOW-WEIGHT CHILDREN" BY HEQUET ET AL IS A PROSPECTIVE STUDY AIMED TO ASSESS THE FEASIBILITY AND SAFETY OF AUTOMATIC PRIMING USING RED BLOOD CELLS (RBCS) (RCE/RBC-PRIMED) USING SPECTRA OPTIA IN PEDIATRIC PATIENTS (N = 12) WITH LOW WEIGHT AND SICKLE CELL ANEMIA. RED BLOOD CELL EXCHANGE SESSIONS WERE PERFORMED EVERY 6 WEEKS. CLINICAL COMPLICATIONS DURING THE 65 RCE/RBC-PRIMED SESSIONS INCLUDED 2 EPISODES OF A DECREASE IN SYSTOLIC BLOOD PRESSURE IN 2 PATIENTS, 2 EPISODES OF AN INCREASE IN HEART RATE IN 2 PATIENTS, AND 3 EPISODES OF FAINTING SENSATION IN 2 PATIENTS. SALINE AND 4% ALBUMIN WERE INFUSED, INDUCING A DECREASE IN HR OR FAINTING SENSATION (WHILE RCE CONTINUED) AND A RAPID INCREASE IN SBP. ALL THE HEMODYNAMIC COMPLICATIONS OCCURRED AT THE END OF THE RCE SESSIONS. AUTHORS ATTRIBUTED THE COMPLICATIONS TO THE LARGE VOLUME OF RED BLOOD CELLS EXCHANGED. RESULTS ARE REPORTED ON PAGES 3 AND 4 AND IN TABLE 2. THE AUTHORS CONCLUDED ¿THE USAGE OF RBC-PRIMING IN LOW-WEIGHT CHILDREN APPEARS NECESSARY AND SAFE WHEN PERFORMING RCE. RBC-PRIMING DID NOT MODIFY THE PERFORMANCES OF RCE. ALTOGETHER, THESE RESULTS SHOULD ENCOURAGE APHERESIS AND PEDIATRIC HEMATOLOGICAL TEAMS TO PERFORM RCE IN THESE LOW WEIGHT CHILDREN WHILE CONSIDERING MANY PRECAUTIONS.¿ 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 UNKNOWN THAT THIS TIME IF MEDICAL INTERVENTION WAS REQUIRED FOR 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 |
|---|---|---|---|---|---|---|---|
| 2406856 | SPECTRA OPTIA | SPECTRA OPTIA EXCHANGE SET | LKN | TERUMO BCT | 10220 | 05020583102200 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other |