TRIMA ACCEL
Report
- Report Number
- 1722028-2020-00173
- Event Type
- Malfunction
- Date Received
- April 17, 2020
- Date of Event
- January 1, 2018
- Report Date
- April 17, 2020
- Manufacturer
- TERUMO BCT
- Product Code
- GKT
- UDI-DI
- 05020583804005
- PMA / PMN Number
- BK190332
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ES
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
THIS REPORT IS BEING FILED TO PROVIDE ADDITIONAL INFORMATION IN B.5 AND H.10. INVESTIGATION: ACCORDING TO 'REACTIONS INDUCED BY PLATELET TRANSFUSIONS', FEBRILE NON-HEMOLYTIC TRANSFUSION REACTIONS (FNHTRS) ARE COMMON IN RECIPIENTS OF PLATELET CONCENTRATES. IT IS WIDELY KNOWN THAT TRANSFUSION OF BLOOD COMPONENTS MAY CAUSE FEBRILE REACTIONS DUE TO LEUKOCYTE OR PLATELET ANTIBODIES IN PATIENTS WHO HAVE RECEIVED PREVIOUS TRANSFUSIONS AND TRANSFUSION REACTIONS CAN STILL OCCUR WITH LEUKOCYTE DEPLETION, RESULTING FROM PLATELET-ASSOCIATED CD40L AND SCD40L INDUCTION OF PROSTAGLANDIN E2 SYNTHESIS AND THE SYNTHESIS OF PRO-INFLAMMATORY CYTOKINES IN A VARIETY OF CELLS IN THE RECIPIENT, INCLUDING ENDOTHELIAL CELLS AND FIBROBLASTS. THE INCIDENCE FOR NONHEMOLYTIC TRANSFUSION REACTIONS IS ESTIMATED TO BE AS HIGH AS 30% OF PLATELET TRANSFUSIONS. ALLERGIC AND ANAPHYLACTIC REACTIONS OCCUR AFTER PLATELET TRANSFUSIONS WITH SIMILAR FREQUENCY AS FNHTRS, BETWEEN 0.09 AND 21% AND ARE HIGHLY VARIABLE IN SEVERITY. MANIFESTATIONS MAY OCCUR AS ISOLATED PRURITUS AND URTICARIA AS THE ONLY DERMAL MANIFESTATIONS. SYSTEMIC REACTIONS MAY INCLUDE BRONCHOCONSTRICTION, HYPOTENSIVE REACTIONS AND SHOCK. ONLY A MINORITY OF ALLERGIC REACTIONS IS ASSOCIATED WITH A RISE IN TEMPERATURE OF 1 °C OR MORE. THE PATHOGENESIS OF ALLERGIC REACTIONS IS HIGHLY HETEROGENEOUS. POSSIBLE REASONS FOR REACTIONS RELATED TO THE TRANSFUSION OF PLATELET CONCENTRATES INCLUDE (I) IGE AND IGG ANTIBODIES IN THE RECIPIENT AGAINST PLASMA PROTEINS IN THE TRANSFUSED BLOOD COMPONENT, (II) TRANSFUSION OF CYTOKINES, CHEMOKINES, AND HISTAMINE GENERATED IN THE PLATELET PRODUCT DURING PREPARATION AND STORAGE. THE BEST-KNOWN TYPE OF ANAPHYLACTIC REACTION IS INDUCED BY IGA DEFICIENCY OF THE RECIPIENT AND SUBSEQUENT FORMATION OF ANTI-IGA. PATIENTS LACKING ONLY ONE IGA SUBCLASS MAY FORM SUBCLASS-SPECIFIC ANTI-IGA; OTHER PATIENTS MAY GET IMMUNIZED AGAINST ALLOTYPES ON THE IGA MOLECULES. PATIENTS WITH SUCH ANTIBODIES OF ¿LIMITED SPECIFICITY¿ USUALLY EXPERIENCE LESS SEVERE ANAPHYLACTIC REACTIONS THAN PATIENTS WITH COMPLETE IGA DEFICIENCY AND CLASS-SPECIFIC ANTI-IGA. INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.
THIS REPORT IS BEING FILED TO PROVIDE ADDITIONAL INFORMATION IN H.10. INVESTIGATION: ACCORDING TO THE AABB CIRCULAR OF INFORMATION FOR THE USE OF HUMAN BLOOD AND BLOOD COMPONENTS (REVISED 2017). FEBRILE NONHEMOLYTIC REACTION IS TYPICALLY MANIFESTED BY A TEMPERATURE ELEVATION OF >1C OR 2F OCCURRING DURING OR WITHIN 4 HOURS AFTER A TRANSFUSION AND IN THE ABSENCE OF ANY OTHER PYREXIC STIMULUS OR ACTIVE WARMING. FEBRILE REACTIONS MAY OCCUR IN LESS THAN 1% OF TRANSFUSION OF LEUKOCYTE-REDUCED RED CELL COMPONENTS AND ABOUT 5% OF LEUKOCYTE-REDUCED APHERESIS PLATELET COMPONENTS. FEBRILE REACTIONS OCCUR MORE FREQUENTLY IN PATIENTS RECEIVING NON- LEUKOCYTE-REDUCED COMPONENTS AND THOSE PREVIOUSLY ALLOIMUNIZED BY TRANSFUSION OR PREGNANCY. ANTIPYRETICS USUALLY PROVIDE EFFECTIVE SYMPTOMATIC RELIEF. PATIENTS WHO EXPERIENCE REPEATED, SEVERE FEBRILE REACTIONS MAY BENEFIT FROM RECEIVING LEUKOCYTE-REDUCED COMPONENTS. IF THESE REACTIONS ARE CAUSED BY CYTOKINES IN THE COMPONENT, PRESTORAGE LEUKOCYTE REDUCTION MAY BE BENEFICIAL. 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. SINCE THIS WAS A RETROSPECTIVE STUDY COMPARING COMPONENTS PROCESSED AND TRANSFUSED BETWEEN (B)(6) 2005 TO (B)(6) 2007 AND COMPONENTS PROCESSED AND TRANSFUSED BETWEEN (B)(6) 2013 TO (B)(6) 2015, THE LOT NUMBERS ARE UNKNOWN; THEREFORE, DHR SEARCHES COULD NOT BE CONDUCTED FOR THIS SPECIFIC INCIDENT. ALL LOTS MUST MEET ACCEPTANCE CRITERIA FOR RELEASE. SINCE THIS WAS A RETROSPECTIVE STUDY COMPARING COMPONENTS PROCESSED AND TRANSFUSED BETWEEN JANUARY 2005 TO DECEMBER 2007 AND COMPONENTS PROCESSED AND TRANSFUSED BETWEEN JANUARY 2013 TO DECEMBER 2015, THE DISPOSABLE SETS WERE NOT AVAILABLE FOR RETURN. INVESTIGATION IS IN PROCESS. A FOLLOW UP REPORT WILL BE PROVIDED.
INVESTIGATION: PER THE ARTICLE: "WITHIN THE FIRST 22 HOURS AFTER COLLECTION, ALL PLT COMPONENTS WERE TRANSFERRED INTO AN ILLUMINATION AND STORAGE BAG AND RIBOFLAVIN SOLUTION WAS ADDED (35 ± 5 ML). THE PLT UNIT WAS PLACED IN THE ILLUMINATOR AND EXPOSED TO UV LIGHT FOR APPROXIMATELY 5 MINUTES WITH LIGHT ENERGY IN THE RANGE OF 265 TO 370 NM, ACCORDING TO THE MANUFACTURER¿S INSTRUCTIONS. PRT-TREATED PLTS WERE STORED FOR UP TO 7 DAYS. ALL PLTS IN BOTH PERIODS WERE LEUKOREDUCED IN ACCORDANCE WITH EUROPEAN AND NATIONAL REQUIREMENTS (RESIDUAL WBC CONTENT BELOW 1E6 PER UNIT IN >90% OF PRODUCTION). OVERALL, THERE WAS A SIGNIFICANT INCREASE IN THE TOTAL NUMBER OF PLT CONCENTRATES TRANSFUSED AT THE BALEARIC ISLANDS UNIVERSITY HOSPITAL DURING THE PRT PERIOD, DESPITE A LOWER NUMBER OF PATIENTS RECEIVING PLTS. THE MEAN TRANSFUSION DOSE OF PLTS PER UNIT WAS SIMILAR FOR BOTH PERIODS. HOWEVER, OVERALL A HIGHER NUMBER OF PLT CONCENTRATES WERE TRANSFUSED TO FEWER PATIENTS DURING THE PRT PERIOD. THEREFORE, THE MEAN NUMBER OF PLT CONCENTRATES AND THE TOTAL DOSE OF PLTS RECEIVED BY EACH PATIENT WERE HIGHER IN THE PRT PERIOD. NEVERTHELESS, WHEN ANALYZING PLT USE PER PATIENT ACCORDING TO THE PRIMARY DIAGNOSIS DATA, IT WAS OBSERVED THAT IT WAS HIGHER FOR HEMATOLOGY AND MEDICAL AND SURGICAL CATEGORIES (EXCLUDING CARDIOVASCULAR SURGERY) IN THE PRT PERIOD. IN CONTRAST, IN ONCOLOGY AND CARDIOVASCULAR CATEGORIES, THE MEAN NUMBER OF PLT CONCENTRATES AND THE TOTAL DOSE OF PLTS RECEIVED BY THE PATIENTS WERE SIMILAR FOR BOTH PERIODS. IT HAS BEEN DESCRIBED THAT PRT-TREATED PLTS SEEMINGLY PRESENT A HYPERACTIVATED STATE, WHICH MAY EXPLAIN THEIR FASTER CLEARANCE AND LOWER RECIRCULATION RATES. IN FACT, RIBOFLAVIN AND UV LIGHT TREATMENT LEADS TO HYPERREACTIVE PLTS, PROBABLY CAUSED BY CONTINUOUS BASAL DEGRANULATION OVER STORAGE TIME. PRT-TREATED PLTS REMAIN IN THE BLOODSTREAM FOR LESS TIME, PATIENTS RECEIVING THEM WILL BE TRANSFUSED MORE FREQUENTLY DUE TO LOWER POST TRANSFUSION PLT INCREMENTS. THE AUTHORS INDICATED THAT EVEN WHEN RIBOFLAVIN AND UV LIGHT¿TREATED PLTS ARE ASSOCIATED WITH A LOWER CCI OR POSTTRANSFUSION PLT COUNT, THIS IS NOT LINKED WITH AN INCREASED RISK OF BLEEDING. RECENT HEMOVIGILANCE STUDIES HAVE ALSO REPORTED THAT THE USE OF RIBOFLAVIN AND UV LIGHT¿TREATED PLTS HAS THE POTENTIAL TO REDUCE THE FREQUENCY OF TRANSFUSION REACTIONS, SPECIFICALLY FEBRILE AND ALLERGIC REACTIONS. IT IS KNOWN THAT PLTS SUSPENDED IN AN ADDITIVE SOLUTION ARE ASSOCIATED WITH LESS ALLERGIC AND FEBRILE TRANSFUSION REACTIONS THAN PLTS STORED IN 100% PLASMA. SUCH REACTIONS CAN ALSO BE PREVENTED BY THE USE OF RIBOFLAVIN AND UV LIGHT TO INACTIVATE WBCS NOT REMOVED BY LEUKOREDUCTION AND THUS AVOID CYTOKINE RELEASE BY WBCS. BOTH PLASMA CONTENT AND CYTOKINE RELEASE IN STORED PLT CONCENTRATES HAVE BEEN INVOLVED IN PLT TRANSFUSION REACTIONS. THE DECREASE OF FEBRILE AND ALLERGIC REACTIONS IN PATIENTS RECEIVING PRT-TREATED PLTS IN THE STUDY COULD BE RELATED NOT ONLY TO THE IMPLEMENTATION OF RIBOFLAVIN AND UV TREATMENT BUT ALSO BECAUSE 100% OF PLTS SUPPLIED DURING THE PRT PERIOD WERE STORED SUSPENDED IN PAS." ROOT CAUSE: A DEFINITIVE ROOT CAUSE OF THE FEBRILE NON-HEMOLYTIC TRANSFUSION REACTIONS COULD NOT BE DETERMINED. IT IS WIDELY KNOWN THAT TRANSFUSION OF BLOOD COMPONENTS MAY CAUSE FEBRILE REACTIONS DUE TO LEUKOCYTE OR PLATELET ANTIBODIES IN PATIENTS WHO HAVE RECEIVED PREVIOUS TRANSFUSIONS AND TRANSFUSION REACTIONS CAN STILL OCCUR WITH LEUKOCYTE DEPLETION, RESULTING FROM PLATELET-ASSOCIATED CD40L AND SCD40L INDUCTION OF PROSTAGLANDIN E2 SYNTHESIS AND THE SYNTHESIS OF PRO-INFLAMMATORY CYTOKINES IN A VARIETY OF CELLS IN THE RECIPIENT, INCLUDING ENDOTHELIAL CELLS AND FIBROBLASTS. A DEFINITIVE ROOT CAUSE OF THE ALLERGIC REACTIONS COULD NOT BE DETERMINED. POSSIBLE REASONS FOR REACTIONS RELATED TO TRANSFUSION OF PLATELET CONCENTRATES INCLUDE (I) IGE AND IGG ANTIBODIES IN THE RECIPIENT AGAINST PLASMA PROTEINS IN THE TRANSFUSED BLOOD COMPONENT, (II) TRANSFUSION OF CYTOKINES, CHEMOKINES, AND HISTAMINE GENERATED IN THE PLATELET PRODUCT DURING PREPARATION AND STORAGE. THE BEST-KNOWN TYPE OF ANAPHYLACTIC REACTION IS INDUCED BY IGA DEFICIENCY OF THE RECIPIENT AND SUBSEQUENT FORMATION OF ANTI-IGA. PATIENTS LACKING ONLY ONE IGA SUBCLASS MAY FORM SUBCLASS- SPECIFIC ANTI-IGA; OTHER PATIENTS MAY GET IMMUNIZED AGAINST ALLOTYPES ON THE IGA MOLECULES. PATIENTS WITH SUCH ANTIBODIES OF ¿LIMITED SPECIFICITY¿ USUALLY EXPERIENCE LESS SEVERE ANAPHYLACTIC REACTIONS THAN PATIENTS WITH COMPLETE IGA DEFICIENCY AND CLASS-SPECIFIC ANTI-IGA. CORRECTED INVESTIGATION: ACCORDING TO 'REACTIONS INDUCED BY PLATELET TRANSFUSIONS' PROVIDED IN SUPPLEMENT 1 IS NO LONGER APPLICABLE FOR THIS EVENT.
PURSUANT TO EU PERSONAL DATA PROTECTION LAWS, THE PATIENT INFORMATION IS NOT AVAILABLE FROM THE CUSTOMER.
LOT NUMBER AND EXPIRY ARE UNAVAILABLE AT THIS TIME. INVESTIGATION: PER THE ARTICLE, THERE WERE NO CASES OF PLT TRANSFUSION¿RELATED SEPSIS OR TRANSFUSION-TRANSMITTED INFECTIONS BY AGENTS SUCH AS L. INFANTUM AND T. CRUZI AND NO OTHER SEVERE TRANSFUSION REACTIONS DURING THE COMPARISON PERIOD. ARTICLE CITATION: JIMINEZ-MARCO, TERESA, GARCIA-RECIO, MARTA, AND GIRONA-LLOBERA, ENRIQUE. 2018. OUR EXPERIENCE IN RIBOFLAVIN AND ULTRAVIOLET LIGHT PATHOGEN REDUCTION TECHNOLOGY FOR PLATELETS: FROM PLATELET PRODUCTION TO PATIENT CARE. TRANSFUSION MEDICINE: 58;1881¿1889. INVESTIGATION IS IN PROCESS. A FOLLOW UP REPORT WILL BE PROVIDED.
PER THE ARTICLE, 'OUR EXPERIENCE IN RIBOFLAVIN AND ULTRAVIOLET LIGHT PATHOGEN REDUCTION TECHNOLOGY FOR PLATELETS: FROM PLATELET PRODUCTION TO PATIENT CARE' IN THE JOURNAL TRANSFUSION MEDICINE, A RETROSPECTIVE STUDY WAS CONDUCTED TO INVESTIGATE THE EFFICACY, SAFETY, AND COST OF 9673 RIBOFLAVIN AND ULTRAVIOLET LIGHT¿TREATED PLATELET (PLT) TRANSFUSIONS GIVEN TO 1211 PATIENTS DURING A 3-YEAR PERIOD. THE RESULTS WERE COMPARED WITH THE EFFICACY, SAFETY, AND COST OF 6424 NONTREATED PLT TRANSFUSIONS ADMINISTERED TO 1500 PATIENTS DURING A 3-YEAR COMPARISON PERIOD (2005 - 2007) BEFORE PRT IMPLEMENTATION. DURING THE 3-YEAR COMPARISON PERIOD, FROM JANUARY 2005 TO DECEMBER 2007, 60% OF PLATELETPHERESIS COMPONENTS WERE COLLECTED USING THREE AUTOMATIC CELLULAR SEPARATORS (TRIMA, TERUMO BCT EUROPE N.V.; AMICUS, FRESENIUS KABI; AND HAEMONETICS MCS+, HAEMONETICS CORP.). OF THE 1500 PATIENTS THAT WERE TRANSFUSED WITH PLATELETS DURING THE COMPARISON PERIOD, 2.5%, OR 38 PATIENTS, HAD FEBRILE REACTIONS AFTER RECEIVING PLATELETS. EXACT PATIENT DETAILS, INCLUDING PATIENT INFORMATION, ANY MEDICAL INTERVENTION REQUIRED FOR THE REACTIONS, AND WHICH REACTIONS OCCURRED ON TERUMO BCT'S TRIMA DEVICE WERE NOT PROVIDED IN THE ARTICLE. THEREFORE, THIS REPORT IS BEING PROVIDED AS A SUMMARY OF THE 38 PATIENT REACTIONS. THE DISPOSABLE SETS WERE NOT AVAILABLE FOR RETURN BECAUSE THEY WERE DISCARDED BY THE CUSTOMER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 438239 | TRIMA ACCEL | TRIMA ACCEL RBC, PLATELET, PLASMA SET | GKT | TERUMO BCT | 80400 | 05020583804005 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |