TRIMA ACCEL
Report
- Report Number
- 1722028-2022-00361
- Event Type
- Injury
- Date Received
- November 11, 2022
- Date of Event
- December 31, 2019
- Report Date
- November 11, 2022
- Manufacturer
- TERUMO BCT
- Product Code
- GKT
- UDI-DI
- 05020583824461
- PMA / PMN Number
- BK190332
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
LOT NUMBER AND EXPIRY ARE NOT AVAILABLE AT THIS TIME. ARTICLE CITATION: ADVERSE EVENTS ASSOCIATED WITH DONOR PLATELETPHERESIS: A 10-YEAR EXPERIENCE FROM VOJVODINA, SERBIA. VOJNOSANITETSKI PREGLED. 2022. 79:751-756 INVESTIGATION IS IN PROCESS. A FOLLOW UP REPORT WILL BE PROVIDED.
THIS REPORT IS BEING FILED TO PROVIDE ADDITIONAL INFORMATION IN H.6 AND H.10. INVESTIGTION: AN INVESTIGATION WAS CONDUCTED FOR A JOURNAL PUBLICATION PRESENTING DATA OF A RETROSPECTIVE ANALYSIS OF ADVERSE EVENTS (AES) ASSOCIATED WITH DONOR PLATELETPHERESIS (PLTP) USING TWO MOBILE CELL SEPARATORS: THE HAEMONETICS MCS®+ CELL SEPARATOR AND THE TRIMA ACCEL® AUTOMATED BLOOD COLLECTION SYSTEM CONDUCTED AT THE BLOOD TRANSFUSION INSTITUTE OF VOJVODINA FROM JANUARY 1, 2010, TO DECEMBER 31, 2019. AES WERE IDENTIFIED DURING 180 (8.68%) PLATELET DONATIONS WITH NO STATISTICAL SIGNIFICANCE IN OCCURRENCE IN THE FIRST TIME DONORS (10.28%) AND REPEAT DONORS (8.59%). THE ANALYSIS SHOWED AES IN 112/1,151 (9.74%) PLATELET DONORS ON THE TRIMA ACCEL®. MILD LOCAL REACTIONS RELATED TO VENOUS ACCESS (42.22%) WERE THE MOST COMMON AES. GENERALIZED SYMPTOMS (WEAKNESS, FAINTING, NAUSEA AND SWEATING, VASOVAGAL SYNCOPE) WERE EXHIBITED IN 16.67% OF DONORS, 26.11% EXHIBITED SYMPTOMS RELATED TO APHERESIS (CITRATE REACTIONS), AND 15% EXHIBITED THOSE RELATED TO OTHER COMPLICATIONS (LIPEMIC PLASMA, ICTERIC PLASMA, INJECTION SITE URTICARIA AND INSTRUMENT FAILURE). IT WAS FOUND THAT 95.55% OF AES OCCURRED DURING PLTP AND ONLY 4.45% AFTER IT. A RETROSPECTIVE ANALYSIS OF AES ASSOCIATED WITH DONOR PLTP IN THE BTI OF VOJVODINA, SERBIA, WAS CONDUCTED FROM JANUARY 1, 2010, TO DECEMBER 31, 2019. DATA FROM THE REGISTER OF AES RELATED TO DONATION WERE USED. DURING THE OBSERVATION PERIOD, 2,073 DONORS UNDERWENT PLTP. PLTP WAS DONE USING TWO MOBILE CELL SEPARATORS: THE HAEMONETICS MCS®+ CELL SEPARATOR (BRAINTREE, MA, USA) AND THE TRIMA ACCEL® AUTOMATED BLOOD COLLECTION SYSTEM (TERUMO BCT). ACCORDING TO THE TIME OF OCCURRENCE, AES ARE DIVIDED INTO AES OCCURRING DURING PROCEDURES AND AES OCCURRING AFTER THE PROCEDURES. ALL AES WERE RECORDED AND CLASSIFIED ACCORDING TO THE INTERNATIONAL HAEMOVIGILANCE NETWORK CATEGORIES OF DONOR AES IN THE FOLLOWING COMPLICATIONS: COMPLICATIONS MAINLY WITH LOCAL SYMPTOMS; COMPLICATIONS MAINLY WITH GENERALIZED SYMPTOMS; COMPLICATIONS RELATED TO APHERESIS SUCH AS CITRATE REACTION, HEMOLYSIS, GENERALIZED ALLERGIC REACTION, AND AIR EMBOLISM; OTHER COMPLICATIONS RELATED TO BLOOD DONATION. LOCAL REACTIONS RELATED TO VENOUS ACCESS ARE THE FOLLOWING: HEMATOMAS (CAUSED BY INCORRECT PLACEMENT OF THE NEEDLE DURING THE VENIPUNCTURE), PAIN, HYPEREMIA, SWELLING; PAIN DUE TO THE SUBCUTANEOUS NERVE IRRITATION/INJURY; LOCAL PHLEBITIS AND THROMBOPHLEBITIS; DELAYED BLEEDING; LOCAL ALLERGY. SYSTEMIC REACTIONS INCLUDE VASOVAGAL REACTIONS (IMMEDIATE/DELAYED), PALLOR, SWEATING, DIZZINESS, GASTROINTESTINAL DISORDERS, NAUSEA, HYPOTENSION, AND BRADYCARDIA. BASED ON THE SEVERITY OF THE AES, THE FOLLOWING DIVISION WAS MADE: GRADE 1 ¿ MILD (HIGH BLOOD PRESSURE, VEIN COLLAPSE, POOR VEIN FLOW, LIP TINGLING, TONGUE TINGLING, FACIAL TIN-GLING, WEAKNESS AND FAINTING, URTICARIA AT THE INJECTION SITE); GRADE 2 ¿ MODERATE (SWEATING, NAUSEA); GRADE 3 ¿ SEVERE (COLLAPSE). DURING THE STUDY PERIOD, 2,073 PERSONS DONATED PLATELETS. JUST 107/2,073 BLOOD DONORS (BDS) DONATED PLATELETS FOR THE FIRST TIME (5.16%). THE MAJORITY OF PLATELET BDS (1,966/2,073) WERE MULTIPLE BDS (94.84%). THE AES WERE IDENTIFIED IN 180/2,073 (8.68%) PLATELET BDS. OUT OF 107 FIRST-TIME BDS, 11 (10.28%) SUFFERED AES. OUT OF 1,966 REPEATED BDS, 169 (8.59%) SUFFERED AES. THE FISHER¿S EXACT TEST (P = 0.4845) SHOWED NO STATISTICALLY SIGNIFICANT DIFFERENCE IN THE INCIDENCE OF AES IN BDS WHO DO-NATED BLOOD FOR THE FIRST OR MULTIPLE TIMES. THE MAJORITY OF DONORS WHO SUFFERED AES (93.89%) BELONGED TO THE REPEAT BDS (169/180). OUT OF 169 REPEATED BDS WITH AES, 45 (26.63%) UNDERWENT PLTP FOR THE FIRST TIME, AND 124 (73.37%) HAD ALREADY UNDERGONE PLTP. TEN BDS HAD ALREADY EXPERIENCED AES DURING THE PREVIOUS PLTP. OUT OF THE 2,073 DONOR PLTP, 1,151 (55.54%) WERE PERFORMED USING TRIMA ACCEL® AND 922 (44.46%) USING HAEMONETICS MCS®+ CELL SEPARATOR. THE ANALYSIS SHOWED AES IN 112/1,151 (9.74%) PLATELET DONORS ON THE TRIMA ACCEL® AND IN 68/922 (7.42%) PLATELET DONORS ON THE HAEMONETICS MCS®+ CELL SEPARATOR. THE FISHER¿S EXACT TEST (P = 0.06) SHOWED NO STATISTICALLY SIGNIFICANT DIFFERENCES BETWEEN THE GROUPS AND OUTCOMES. THE MOST COMMON CAUSE OF AES ASSOCIATED WITH DONOR PLTP WAS VENIPUNCTURE IN 76 (42.22%) DONORS. TYPES OF AES DURING DONOR PLTP ARE SHOWN IN TABLE 1. THE LARGEST NUMBER OF AES OCCURRED DUE TO LOCAL SYMPTOMATOLOGY IN 76/2,073 (3.66%) DONORS. MILD AES OCCURRED IN 166 (92.22%), MODERATE IN SIX (3.33%), AND SEVERE IN EIGHT (4.45%) DONORS. THE MOST COMMON AE WAS A COLLAPSED VEIN THAT OCCURRED IN 41 (22.78%) BDS. THE DEMOGRAPHIC CHARACTERISTICS OF PLATELET DONORS (GENDER, AGE) ARE SHOWN IN TABLE 2. NO STATISTICALLY SIGNIFICANT DIFFERENCES WERE OBSERVED IN THE OCCURRENCE OF AES BETWEEN MEN AND WOMEN (FISHER¿S EXACT TEST, P = 1). AES WERE STATISTICALLY SIGNIFICANTLY MORE FREQUENT IN PLATELET DONORS AGED 36-45 (THE ¿2 STATISTIC WAS 51.767, P < 0.00001). THE STUDY SHOWED THAT 172 (95.55%) AES OCCURRED DURING PLTP, WHILE EIGHT (4.45%) AES OCCURRED AFTER PLTP. THE STUDY FOUND THAT THE AES OCCURRED IN 8.68% OF PLATELET DONORS AS WELL AS THAT MOST OF THEM OCCURRED DURING PLTP. MILD LOCAL REACTIONS RELATED TO VENOUS ACCESS WERE THE MOST COMMON AES OBSERVED WITH APHERESIS PROCEDURES. THE HIGHEST OCCURRENCE OF AES WAS RECORDED IN PLATELET DONORS AGED 36¿45. DURING THE OBSERVATION PERIOD, THE STUDY FOUND THAT REPEAT MALE BDS WERE MOSTLY SELECTED FOR PLATELET DONORS. ALTHOUGH NO STATISTICALLY SIGNIFICANT DIFFERENCE WAS FOUND IN THE INCIDENCE OF AES IN PLATELET DONORS WHO DONATED BLOOD/PLATELETS FOR THE FIRST OR MULTIPLE TIMES, THE MAJORITY OF DONORS WHO SUFFERED AES (93.89%) WERE REPEATED DONORS (169/180). NO STATISTICAL DIFFERENCE IN THE OCCURRENCE OF AES BETWEEN MEN AND WOMEN WAS FOUND. HOWEVER, AES HAPPENED SIGNIFICANTLY MORE FREQUENTLY IN DONORS WHO EXPERIENCED AES DURING THE PREVIOUS PLTP. NO SIGNIFICANT DIFFERENCE WAS NOTED IN AES RELATED TO THE TWO CELL SEPARATORS USED FOR PLTP. CONCLUSION OF THE ARTICLE: THE LOW INCIDENCE OF USUALLY MILD AES RELATED TO PLTP INDICATES THAT THE PROCEDURE IS GENERALLY SAFE AND WELL TOLERATED BY DONORS. UNDERSTANDING THE PLTP-RELATED RISK FACTORS FOR AES PROVIDES SUPPORT FOR THE ADOPTION OF MEASURES TO PREVENT THEIR OCCURRENCE. SINCE THIS WAS A JOURNAL PUBLICATION PRESENTING DATA OF A RETROSPECTIVE ANALYSIS OF ADVERSE EVENTS (AES) ASSOCIATED WITH DONOR PLATELETPHERESIS (PLTP) FROM JANUARY 1, 2010, TO DECEMBER 31, 2019, 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. MILD LOCAL REACTIONS RELATED TO VENOUS ACCESS (42.22%) WERE THE MOST COMMON AES. GENERALIZED SYMPTOMS (WEAKNESS, FAINTING, NAUSEA AND SWEATING, VASOVAGAL SYNCOPE) WERE EXHIBITED IN 16.67% OF DONORS, 26.11% EXHIBITED SYMPTOMS RELATED TO APHERESIS (CITRATE REACTIONS), AND 15% EXHIBITED THOSE RELATED TO OTHER COMPLICATIONS (LIPEMIC PLASMA, ICTERIC PLASMA, INJECTION SITE URTICARIA AND INSTRUMENT FAILURE). ACCORDING TO AABB TECHNICAL MANUAL 16TH EDITION, ADVERSE EVENTS SEEN AT THE TIME OF DONATION OR THOSE REPORTED LATER AVERAGE ABOUT 3.5% OF DONATIONS. REACTIONS THAT NEED MEDICAL CARE AFTER THE DONOR HAS LEFT THE DONATION SITE ARE SEEN IN 1 IN 3400 DONORS. ROOT CAUSE: 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: * DONOR ACCESS WAS NOT PROPERLY POSITIONED * INLET LINE OR RETURN LINE WAS OBSTRUCTED DUE TO KINKS, CLAMPS, OR CLUMPING * INLET OR RETURN PUMP FLOW RATE WAS TOO HIGH FOR THE SIZE OF THE DONOR ACCESS A ROOT CAUSE ASSESSMENT WAS PERFORMED FOR THE GENERALIZED SYMPTOMS (WEAKNESS, FAINTING, NAUSEA AND SWEATING, VASOVAGAL SYNCOPE). THESE REACTIONS ARE COMMON SIDE EFFECTS OF THERAPEUTIC APHERESIS PROCEDURES. THEY ARE TYPICALLY CAUSED BY FLUID SHIFT, BLOOD LOSS, LENGTH OF THE PROCEDURE, DONOR'S SENSITIVITY TO THE PROCEDURE AND/OR HEMODYNAMIC STRESS OF THE PROCEDURE. A SPECIFIC ROOT CAUSE FOR THE REPORTED CITRATE REACTIONS COULD NOT BE DETERMINED. THESE REACTIONS OCCUR DUE TO DECREASED IONIZED CALCIUM IN CIRCULATION AS A RESULT OF EXOGENOUS CITRATE ADMINISTERED DURING THE APHERESIS PROCEDURE AND ARE INFLUENCED BY DONOR 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 ACD INFUSION. A ROOT CAUSE ASSESSMENT WAS PERFORMED FOR THE LIPEMIC AND ICTERIC PLASMA. 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: * DONOR PHYSIOLOGY * DONOR ON CERTAIN MEDICATIONS A ROOT CAUSE ASSESSMENT WAS PERFORMED FOR THE INJECTION SITE URTICARIA. 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: * DONOR SENSITIVITY TO THE SKIN DISINFECTANT * DONOR SENSITIVITY TO THE ADHESIVE ON THE BANDAGE A ROOT CAUSE ASSESSMENT WAS PERFORMED FOR THE INSTRUMENT FAILURE. 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: * A MACHINE MALFUNCTION * A DEFECTIVE DISPOSABLE SET * AN OPERATOR ERROR ARTICLE CITATION: ADVERSE EVENTS ASSOCIATED WITH DONOR PLATELETPHERESIS: A 10-YEAR EXPERIENCE FROM VOJVODINA, SERBIA. VOJNOSANITETSKI PREGLED. 2022. 79:751-756
THE JOURNAL ARTICLE, ADVERSE EVENTS ASSOCIATED WITH DONOR PLATELETPHERESIS: A 10-YEAR EXPERIENCE FROM VOJVODINA, SERBIA, DESCRIBES A RETROSPECTIVE STUDY ON ADVERSE EVENTS (AES) RELATED TO PLATETPHERESIS (PLTP). A RETROSPECTIVE ANALYSIS OF AES ASSOCIATED WITH DONOR PLTP IN THE BTI OF VOJVODINA, SERBIA, WAS CONDUCTED FROM JANUARY 1, 2010, TO DECEMBER 31, 2019. DATA FROM THE REGISTER OF AES RELATED TO DONATION WERE USED. DURING THE OBSERVATION PERIOD, 2,073 DONORS UNDERWENT PLTP. PLTP WAS DONE USING TWO MOBILE CELL SEPARATORS: THE HAEMONETICS MCS®+ CELL SEPARATOR (BRAINTREE, MA, USA) AND THE TRIMA ACCEL® AUTOMATED BLOOD COLLECTION SYSTEM (TERUMO BCT). THE ANALYSIS SHOWED AES IN 112/1,151 (9.74%) PLATELET DONORS ON THE TRIMA ACCEL®. AES WERE IDENTIFIED DURING 180 (8.68%) PLATELET DONATIONS WITH NO STATISTICAL SIGNIFICANCE IN OCCURRENCE IN THE FIRST TIME DONORS (10.28%) AND REPEAT DONORS (8.59%). MILD LOCAL REACTIONS RELATED TO VENOUS ACCESS (42.22%) WERE THE MOST COMMON AES. GENERALIZED SYMPTOMS WERE EXHIBITED IN 16.67% OF DONORS, 26.11% EXHIBITED SYMPTOMS RELATED TO APHERESIS (CITRATE REACTIONS), AND 15% EXHIBITED THOSE RELATED TO OTHER COMPLICATIONS. IT WAS FOUND THAT 95.55% OF AES OCCURRED DURING PLTP AND ONLY 4.45% AFTER IT. PLTP WAS PERFORMED ON HEALTHY NON-REMUNERATED FIRSTTIME VOLUNTEERS OR REPEAT BLOOD DONORS (BD), SOME OF WHOM DONATED PLATELETS FOR THE FIRST TIME. PATIENT (DONOR) DETAILS WERE NOT AVAILABLE IN THE ARTICLE FOR SPECIFIC EVENTS, THEREFORE THIS REPORT IS BEING FILED AS A SUMMARY OF EVENTS. THE PLTP SETS ARE NOT AVAILABLE FOR RETURN FOR EVALUATION.
THE JOURNAL ARTICLE, ADVERSE EVENTS ASSOCIATED WITH DONOR PLATELETPHERESIS: A 10-YEAR EXPERIENCE FROM VOJVODINA, SERBIA, DESCRIBES A RETROSPECTIVE STUDY ON ADVERSE EVENTS (AES) RELATED TO PLATETPHERESIS (PLTP). A RETROSPECTIVE ANALYSIS OF AES ASSOCIATED WITH DONOR PLTP IN THE BTI OF VOJVODINA, SERBIA, WAS CONDUCTED FROM JANUARY 1, 2010, TO DECEMBER 31, 2019. DATA FROM THE REGISTER OF AES RELATED TO DONATION WERE USED. DURING THE OBSERVATION PERIOD, 2,073 DONORS UNDERWENT PLTP. PLTP WAS DONE USING TWO MOBILE CELL SEPARATORS: THE HAEMONETICS MCS®+ CELL SEPARATOR (BRAINTREE, MA, USA) AND THE TRIMA ACCEL® AUTOMATED BLOOD COLLECTION SYSTEM (TERUMO BCT). THE ANALYSIS SHOWED AES IN 112/1,151 (9.74%) PLATELET DONORS ON THE TRIMA ACCEL®. AES WERE IDENTIFIED DURING 180 (8.68%) PLATELET DONATIONS WITH NO STATISTICAL SIGNIFICANCE IN OCCURRENCE IN THE FIRST TIME DONORS (10.28%) AND REPEAT DONORS (8.59%). MILD LOCAL REACTIONS RELATED TO VENOUS ACCESS (42.22%) WERE THE MOST COMMON AES. GENERALIZED SYMPTOMS WERE EXHIBITED IN 16.67% OF DONORS, 26.11% EXHIBITED SYMPTOMS RELATED TO APHERESIS (CITRATE REACTIONS), AND 15% EXHIBITED THOSE RELATED TO OTHER COMPLICATIONS. IT WAS FOUND THAT 95.55% OF AES OCCURRED DURING PLTP AND ONLY 4.45% AFTER IT. PLTP WAS PERFORMED ON HEALTHY NON-REMUNERATED FIRSTTIME VOLUNTEERS OR REPEAT BLOOD DONORS (BD), SOME OF WHOM DONATED PLATELETS FOR THE FIRST TIME. PATIENT (DONOR) DETAILS WERE NOT AVAILABLE IN THE ARTICLE FOR SPECIFIC EVENTS, THEREFORE THIS REPORT IS BEING FILED AS A SUMMARY OF EVENTS. THIS WAS A JOURNAL PUBLICATION PRESENTING DATA OF A RETROSPECTIVE ANALYSIS OF ADVERSE EVENTS (AES) ASSOCIATED WITH DONOR PLATELETPHERESIS (PLTP) FROM JANUARY 1, 2010, TO DECEMBER 31, 2019. A REQUEST FOR SPECIFIC PATIENT INFORMATION IS NOT FEASIBLE. THE PLTP SETS ARE NOT AVAILABLE FOR RETURN FOR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2878061 | TRIMA ACCEL | TRIMA PLATELET+SAMPLER, PLASMA, RB | GKT | TERUMO BCT | 82446 | 05020583824461 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other |