SPECTRA OPTIA
Report
- Report Number
- 1722028-2024-00322
- Event Type
- Injury
- Date Received
- August 6, 2024
- Date of Event
- April 29, 2019
- Report Date
- August 6, 2024
- Manufacturer
- TERUMO BCT
- Product Code
- LKN
- UDI-DI
- 05020583122208
- PMA / PMN Number
- K183081
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
LOT NUMBER, MANUFACTURE AND EXPIRY DATE ARE NOT AVAILABLE AT THIS TIME. INVESTIGATION IS IN PROCESS, A FOLLOW-UP REPORT WILL BE PROVIDED. CITATION: BAJPAI, M., KAKKAR, B., GUPTA, S., RASTOGI, A., & PAMECHA, V. (2019). CASCADE PLASMAPHERESIS AS A DESENSITIZATION STRATEGY FOR PATIENTS UNDERGOING ABO INCOMPATIBLE LIVING DONOR LIVER TRANSPLANTATION (ABOI LDLT): A SINGLE CENTER EXPERIENCE. TRANSFUSION AND APHERESIS SCIENCE, 58(4), 442446. HTTPS://DOI.ORG/10.1016/J.TRANSCI.2019.04.028.
THIS REPORT IS BEING FILED TO PROVIDE ADDITIONAL INFORMATION IN H.6 AND H.11. INVESTIGATION: SINCE THIS WAS A JOURNAL PUBLICATION TO ASSESS CASCADE PLASMAPHERESIS AS A DESENSITIZATION STRATEGY FOR 4 PATIENTS (MEAN AGE 46.7 YEARS; 100% MALES) UNDERGOING ABO INCOMPATIBLE LIVING DONOR LIVER TRANSPLANTATION (ABOI LDLT) FROM MARCH 2015 TO DECEMBER 2016., THE LOT NUMBERS WERE NOT REQUESTED; THEREFORE, A DHR SEARCH COULD NOT BE CONDUCTED FOR THIS SPECIFIC INCIDENT. ALL LOTS MUST MEET ACCEPTANCE CRITERIA FOR RELEASE. SINCE THIS WAS A JOURNAL PUBLICATION TO ASSESS CASCADE PLASMAPHERESIS AS A DESENSITIZATION STRATEGY FOR 4 PATIENTS (MEAN AGE 46.7 YEARS; 100% MALES) UNDERGOING ABO INCOMPATIBLE LIVING DONOR LIVER TRANSPLANTATION (ABOI LDLT) FROM MARCH 2015 TO DECEMBER 2016, THE LOT NUMBERS WERE NOT REQUESTED; THEREFORE, A DISPOSABLE LOT HISTORY SEARCH COULD NOT BE CONDUCTED. SUMMARY OF TERUMO BCT PRODUCT IN RELATION TO THE JOURNAL ARTICLE: THIS RETROSPECTIVE OBSERVATIONAL STUDY WAS CONDUCTED IN THE TERTIARY CARE HOSPITAL FROM MARCH 2015 TO DECEMBER 2016 IN PATIENTS WHO UNDERWENT ABOI LDLT, AFTER APPROVAL FROM THE INSTITUTIONAL ETHICS COMMITTEE. PATIENT RECORDS WERE RETRIEVED AND REVIEWED FOR AGE, GENDER, PRIMARY DIAGNOSIS, COMORBID CONDITIONS, MODEL FOR END-STAGE LIVER DISEASE (MELD) SCORE, DESENSITIZATION PROTOCOL DETAILS AND DEMOGRAPHIC PROFILE OF THEIR DONORS. THE DESENSITIZATION PROTOCOL AT OUR INSTITUTE CONSISTED OF A SINGLE DOSE OF RITUXIMAB ADMINISTRATION (100 MG; DAY -21). CASCADE PLASMAPHERESIS WAS PERFORMED USING COBE SPECTRA (TERUMO BCT, LAKEWOOD, CO) AND SPECTRA OPTIA (TERUMO BCT, LAKEWOOD, CO) USING CENTRAL VENOUS ACCESS AND ACD A (ACID CITRATE DEXTROSE A) AS ANTICOAGULANT (INFUSION RATE 0.8.1.2 ML/ACD A/MIN/L TOTAL BLOOD VOLUME) WITH DUE CONSENT FROM ALL PATIENTS. EVAFLUX 2A (PORE SIZED BASED FILTER COLUMN; KAWASUMI LABORATORIES, JAPAN) WAS USED. TOTAL BLOOD VOLUME WAS CALCULATED USING NADLER'S FORMULA AND AROUND 1.5.3 PLASMA VOLUMES WERE PROCESSED IN EACH SESSION. CP WAS PERFORMED DAILY OR ALTERNATE DAY WITH DAILY AT MONITORING UNTIL TARGET TITRE OF 8 WAS ACHIEVED. TRIPLE IMMUNOSUPPRESSION WAS GIVEN AS A PART OF INDUCTION THERAPY CONSISTING OF TACROLIMUS (DOSE 0.5 TO 1 MG/DAY; TARGET LEVELS 10 TO 12 NG/ML DURING FIRST THREE MONTHS, 5 TO 8 NG/ML FROM 3 TO 6 MONTHS AND LESS THAN 5 NG/ML THEREAFTER; STARTED ON POSTOPERATIVE DAY 1, POD 1), MYCOPHENOLATE MOFETIL (1000 MG TWICE A DAY; ALONG WITH THE DAILY MONITORING FOR CYTOPENIA'S; STARTED ON POD 1) AND STEROIDS (INTRAOPERATIVE [DAY 0] 100 MG METHYLPREDNISOLONE, FOLLOWED BY 80 MG ON POD 1, 60 MG ON POD 2, 40 MG ON POD 3, 20 MG ORAL PREDNISOLONE ON POD 4 TO BE CONTINUED FOR 3 MONTHS, FOLLOWED BY GRADUAL TAPERING OVER 6 MONTHS, WITH THE AIM TO STOP BY THE END OF 1 YEAR). CONVENTIONAL TPE WAS CONSIDERED IF THE RISE IN AT LEVELS WAS NOTED IN THE POST-TRANSPLANT PHASE. ALL THE PATIENTS WERE ADMINISTRATED 10% CALCIUM GLUCONATE INFUSION AT A RATE OF 10-20 ML/HOUR (DEPENDING UPON THE IONIZED CALCIUM LEVELS) PROPHYLACTICALLY TO REDUCE THE RISK OF CITRATE TOXICITY. ARTERIAL BLOOD GAS/VENOUS BLOOD GAS (ABG/VBG) ANALYSIS WAS PERFORMED PRE-, DURING (AT HOURLY INTERVAL) AND POST-PROCEDURE TO MONITOR THE IONIZED CALCIUM LEVELS. PATIENTS WERE FOLLOWED UP REGULARLY TO DETERMINE THEIR CLINICAL STATUS POST-TRANSPLANTATION ALONG WITH ASSESSMENT OF ROUTINE LABORATORY WORKUP (COMPLETE BLOOD COUNTS, LIVER FUNCTION TESTS AND COAGULATION PROFILE). DURING THE STUDY PERIOD, FOUR PATIENTS UNDERWENT DESENSITIZATION FOR ABOI LDLT WITH A MEAN AGE OF 46.7 YEARS (100% MALES) WITH BASELINE AT (COMBINED IGM AND IGG) RANGING FROM 64 TO 512. ALL PATIENTS RECEIVED RITUXIMAB 21 DAYS PRIOR TO THE STIPULATED DATE OF TRANSPLANTATION. PATIENT DEMOGRAPHICS AND PROCEDURAL DETAILS ARE SUMMARIZED IN TABLE 1. A TOTAL OF 15 CP SESSIONS (RANGE 2-6) WERE PERFORMED WITH A MEDIAN OF 3.5 SESSIONS/PATIENT. DESENSITIZATION RATE WAS 100% AS TARGET TITRE OF 8 WAS ACHIEVED IN ALL FOUR PATIENTS. AMONG THEM, ONLY ONE PATIENT UNDERWENT CONVENTIONAL TPE IN THE POST-TRANSPLANT PHASE DUE TO RISE IN AT LEVEL TO 64 ON POD 8. THE MEAN TIME IN MINUTES/ PLASMA VOLUME TREATED WAS 167.5 MIN FOR COBE SPECTRA AND 100.5 MIN FOR SPECTRA OPTIA. A HIGHER RATE OF COMPLICATIONS WAS NOTED ON DOING PROCEDURES WITH COBE SPECTRA (50%; 5/10 SESSIONS) AS COMPARED TO SPECTRA OPTIA 50% (40%; 4/10 SESSIONS). PATIENTS WHO UNDERWENT CP ON COBE SPECTRA EXPERIENCED HYPOTENSION (MANAGED WITH VASOPRESSORS SUPPORT) PREDOMINATELY AND PRURITUS DUE TO FRESH FROZEN PLASMA (FFP) TRANSFUSION (MANAGED WITH ANTI-HISTAMINIC AND STEROID). WHEREAS PATIENTS WHO UNDERWENT CP ON SPECTRA OPTIA EXPERIENCED PERIORAL PARAESTHESIA (AT THE END OF THE PROCEDURE; MANAGED WITH CALCIUM SUPPLEMENTATION), HYPOTENSION (MANAGED WITH VASOPRESSOR SUPPORT) AND PRURITUS DUE TO FRESH FROZEN PLASMA (FFP) TRANSFUSION (MANAGED WITH ANTI-HISTAMINIC AND STEROID). ONE PROCEDURE PERFORMED USING SPECTRA OPTIA WAS ABORTED DUE TO DEVELOPMENT OF ANAPHYLACTIC REACTION TO FFP TRANSFUSION (MANAGED WITH SUPPORTIVE CARE, ANTI-HISTAMINIC, STEROID, AND ADRENALINE). AVERAGE POST-OPERATIVE LENGTH OF STAY WAS 49 DAYS (RANGE 30-105). NONE OF THE PATIENTS EXPERIENCED ANY EPISODE OF REJECTION (REPEAT LIVER BIOPSY). ON ONE YEAR FOLLOW UP, 2 PATIENTS WERE ALIVE AND DOING WELL, WHILE OTHER 2 PATIENTS SUCCUMBED DURING THEIR HOSPITAL STAY DUE TO SEPSIS (PATIENT 2 POD 105; PATIENT 4 POD 30). ONE OF THE MOST COMMON ADVERSE EFFECTS NOTED DURING CP WAS HYPOCALCEMIA RELATED TO USE OF CITRATE WHICH CHELATES CALCIUM. THIS COMPLICATION IS MORE PRONOUNCED IN PATIENTS WITH COMPROMISED LIVER FUNCTION AS A MAJOR PART OF THE CITRATE IS METABOLIZED IN THE LIVER. IN VIEW OF THIS, ALL PATIENTS WERE GIVEN CALCIUM GLUCONATE INFUSION PROPHYLACTICALLY IN TITRATED DOSES THROUGHOUT THE PROCEDURE. ANOTHER ADVANTAGE OF SPECTRA OPTIA OVER COBE SPECTRA IS THAT IT CONTINUOUSLY MONITORS THE TOTAL VOLUME OF ACD-A INFUSED TO THE PATIENT AT ANY GIVEN TIME DURING THE PROCEDURE, WHICH FURTHER HELPS IN TITRATING THE ACD-A LEVELS TO PREVENT CITRATE RELATED EFFECTS. IN SPITE OF THIS ONE PATIENT DID EXPERIENCE CITRATE RELATED ADVERSE EFFECTS THAT IS PERIORAL PARAESTHESIA (MANAGED EFFECTIVELY WITH IV CALCIUM SUPPLEMENTATION), WHICH MIGHT BE DUE TO A HIGHER INLET BLOOD FLOW RATE. ONE OF THE PATIENTS ALSO DEVELOPED SEVERE ANAPHYLACTIC REACTION DUE TO FFP USAGE FOR WHICH THE PROCEDURE WAS ABORTED, AND THE PATIENT WAS MANAGED WITH SUPPORTIVE CARE, ANTI-HISTAMINIC, STEROIDS, AND ADRENALINE. PATIENTS DEVELOPING SEVERE ANAPHYLACTIC REACTION DUE TO FFP TRANSFUSION HAS BEEN REPORTED IN THE PUBLISHED LITERATURE. OVERALL, THE AUTHORS CONCLUDED IN THEIR LIMITED EXPERIENCE WITH A FEW PATIENTS, THE USE OF CP WAS SAFE AND EFFECTIVE DESENSITIZATION STRATEGY FOR PATIENTS UNDERGOING ABOI LDLT. THEY WERE ALSO ABLE TO REDUCE THE AT LEVELS PRE-TRANSPLANT TO A LEVEL CONSIDERED SAFE (8) FOR TRANSPLANTATION WHICH HELPED IN PREVENTING ANY EPISODE OF ACUTE HUMORAL REJECTION AFTER TRANSPLANTATION. ADDITIONALLY, WE ALSO OBSERVED THE AT LEVELS REMAINED STABLE FOR ALL OUR PATIENTS IN THE POST-TRANSPLANT PHASE. 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. TRANSIENT HYPOCALCEMIA ASSOCIATED WITH APHERESIS IS USUALLY WELL TOLERATED. SYMPTOMS OFTEN SHOW AS PARASETHESIA (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. 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 (THERAPEUTIC APHERESIS: A PHYSICIAN'S HANDBOOK, PGS 28-33). ROOT CAUSE: BASED ON THE AVAILABLE INFORMATION WITHIN THE JOURNAL ARTICLE, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. A ROOT CAUSE ASSESSMENT WAS PERFORMED FOR THE PATIENT REACTIONS. CITATE 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 RATE OF AC INFUSION, 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 AUTHORS DETERMINED THAT THE ALLERGIC REACTIONS WERE A POSSIBLE SIDE EFFECT FROM THE FFP USED AS THE REPLACEMENT FLUIDS DURING THE PROCEDURE. THE REPORTED HYPOTENSION IS A COMMON SIDE EFFECT OF THERAPEUTIC APHERESIS PROCEDURES. IT IS TYPICALLY CAUSED BY FLUID SHIFT, BLOOD LOSS, LENGTH OF THE PROCEDURE, PATIENT'S SENSITIVITY TO THE PROCEDURE AND/OR HEMODYNAMIC STRESS OF THE PROCEDURE. CITATION: BAJPAI, M., KAKKAR, B., GUPTA, S., RASTOGI, A., & PAMECHA, V. (2019). CASCADE PLASMAPHERESIS AS A DESENSITIZATION STRATEGY FOR PATIENTS UNDERGOING ABO INCOMPATIBLE LIVING DONOR LIVER TRANSPLANTATION (ABOI LDLT): A SINGLE CENTER EXPERIENCE. TRANSFUSION AND APHERESIS SCIENCE, 58(4), 442-446. HTTPS://DOI.ORG/10.1016/J.TRANSCI.2019.04.028.
PER JOURNAL ARTICLE "CASCADE PLASMAPHERESIS AS A DESENSITIZATION STRATEGY FOR PATIENTS UNDERGOING ABO INCOMPATIBLE LIVING DONOR LIVER TRANSPLANTATION (ABOI LDLT): A SINGLE CENTER EXPERIENCE" BY MEENU BAJPAI, BRINDA KAKKARA, SHRUTI GUPTAA, ARCHANA RASTOGIB, VINIYENDRA PAMECHAC BACKGROUND AND AIM: THE REDUCTION OF ANTIBODY TITRES (AT'S) TO A SAFE LEVEL IS ESSENTIAL PRE-REQUISITE FOR PATIENTS AWAITING ABO-INCOMPATIBLE LIVER TRANSPLANTATION (ABOI LT). WE REPORT OUR EXPERIENCE OF PERFORMING CASCADE PLASMAPHERESIS (CP) ON 2 DIFFERENT APHERESIS PLATFORMS (COBE SPECTRA AND SPECTRA OPTIA) AS A DESENSITIZATION STRATEGY FOR PATIENTS UNDERGOING ABOI LT IN OUR CENTRE. METHODS: THIS RETROSPECTIVE OBSERVATIONAL STUDY WAS CONDUCTED ON PATIENTS WHO UNDERWENT CP INCLUDED IN THE DESENSITIZATION PROTOCOL FOR ABOI LDLT. CP/CONVENTIONAL TPE WAS PERFORMED (DAILY/ALTERNATE DAY WITH DAILY ESTIMATION OF AT) UNTIL A TARGET TITRE OF ¿¿¿ 8 WAS ACHIEVED. RESULTS: DURING THE STUDY PERIOD, 4 PATIENTS (MEAN AGE 46.7 YEARS; 100% MALES) UNDERWENT DESENSITIZATION FOR ABOI LDLT WITH BASELINE AT (COMBINED IGM AND IGG) RANGING FROM 64 TO 512. A TOTAL OF 15 CP SESSIONS (RANGE 2 - 6) WERE PERFORMED WITH A MEDIAN OF 3.5 SESSIONS/PATIENT. DESENSITIZATION RATE WAS 100%. ONLY 1 PATIENT UNDERWENT CONVENTIONAL TPE IN THE POST-TRANSPLANT DUE TO RISE IN AT LEVEL TO 64 (POST-OPERATIVE DAY 8). AVERAGE POST-OPERATIVE LENGTH OF STAY WAS 49 DAYS (RANGE 30 - 105). NONE OF THE PATIENTS EXPERIENCED ANY EPISODE OF REJECTION (REPEAT LIVER BIOPSY). ON FOLLOW UP (1 YEAR), 2 PATIENTS WERE ALIVE AND DOING WELL, WHILE OTHER 2 PATIENTS SUCCUMBED DURING THEIR HOSPITAL STAY DUE TO SEPSIS. CONCLUSION: IN OUR LIMITED EXPERIENCE, THE USE OF CP WAS SAFE AND EFFECTIVE DESENSITIZATION STRATEGY FOR PATIENTS UNDERGOING ABOI LDLT. IT WAS OBSERVED THAT ONE OF THE PATIENTS ALSO DEVELOPED SEVERE ANAPHYLACTIC REACTION DUE TO FFP USAGE FOR WHICH THE PROCEDURE WAS ABORTED, AND THE PATIENT WAS MANAGED WITH SUPPORTIVE CARE, ANTI-HISTAMINIC, STEROIDS, AND ADRENALINE. PATIENT WEIGHT IS UNKNOWN. PER JOURNAL ARTICLE PATIENT IS IN STABLE CONDITION. THE COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.
PER JOURNAL ARTICLE "CASCADE PLASMAPHERESIS AS A DESENSITIZATION STRATEGY FOR PATIENTS UNDERGOING ABO INCOMPATIBLE LIVING DONOR LIVER TRANSPLANTATION (ABOI LDLT): A SINGLE CENTER EXPERIENCE" BY MEENU BAJPAI, BRINDA KAKKARA, SHRUTI GUPTAA, ARCHANA RASTOGIB, VINIYENDRA PAMECHAC BACKGROUND AND AIM: THE REDUCTION OF ANTIBODY TITRES (AT'S) TO A SAFE LEVEL IS ESSENTIAL PRE-REQUISITE FOR PATIENTS AWAITING ABO-INCOMPATIBLE LIVER TRANSPLANTATION (ABOI LT). WE REPORT OUR EXPERIENCE OF PERFORMING CASCADE PLASMAPHERESIS (CP) ON 2 DIFFERENT APHERESIS PLATFORMS (COBE SPECTRA AND SPECTRA OPTIA) AS A DESENSITIZATION STRATEGY FOR PATIENTS UNDERGOING ABOI LT IN OUR CENTRE. METHODS: THIS RETROSPECTIVE OBSERVATIONAL STUDY WAS CONDUCTED ON PATIENTS WHO UNDERWENT CP INCLUDED IN THE DESENSITIZATION PROTOCOL FOR ABOI LDLT. CP/CONVENTIONAL TPE WAS PERFORMED (DAILY/ALTERNATE DAY WITH DAILY ESTIMATION OF AT) UNTIL A TARGET TITRE OF 8 WAS ACHIEVED. RESULTS: DURING THE STUDY PERIOD, 4 PATIENTS (MEAN AGE 46.7 YEARS; 100% MALES) UNDERWENT DESENSITIZATION FOR ABOI LDLT WITH BASELINE AT (COMBINED IGM AND IGG) RANGING FROM 64 TO 512. A TOTAL OF 15 CP SESSIONS (RANGE 2 - 6) WERE PERFORMED WITH A MEDIAN OF 3.5 SESSIONS/PATIENT. DESENSITIZATION RATE WAS 100%. ONLY 1 PATIENT UNDERWENT CONVENTIONAL TPE IN THE POST-TRANSPLANT DUE TO RISE IN AT LEVEL TO 64 (POST-OPERATIVE DAY 8). AVERAGE POST-OPERATIVE LENGTH OF STAY WAS 49 DAYS (RANGE 30 - 105). NONE OF THE PATIENTS EXPERIENCED ANY EPISODE OF REJECTION (REPEAT LIVER BIOPSY). ON FOLLOW UP (1 YEAR), 2 PATIENTS WERE ALIVE AND DOING WELL, WHILE OTHER 2 PATIENTS SUCCUMBED DURING THEIR HOSPITAL STAY DUE TO SEPSIS. CONCLUSION: IN OUR LIMITED EXPERIENCE, THE USE OF CP WAS SAFE AND EFFECTIVE DESENSITIZATION STRATEGY FOR PATIENTS UNDERGOING ABOI LDLT. IT WAS OBSERVED THAT ONE OF THE PATIENTS ALSO DEVELOPED SEVERE ANAPHYLACTIC REACTION DUE TO FFP USAGE FOR WHICH THE PROCEDURE WAS ABORTED, AND THE PATIENT WAS MANAGED WITH SUPPORTIVE CARE, ANTI-HISTAMINIC, STEROIDS, AND ADRENALINE. PATIENT WEIGHT IS UNKNOWN. PER JOURNAL ARTICLE PATIENT IS IN STABLE CONDITION. THE COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1673851 | SPECTRA OPTIA | SPECTRA OPTIA EXCHANGE SET | LKN | TERUMO BCT | 05020583122208 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR | Male | Other| R |