TRIMA ACCEL
Report
- Report Number
- 1722028-2024-00065
- Event Type
- Injury
- Date Received
- February 27, 2024
- Date of Event
- July 21, 2023
- Report Date
- February 27, 2024
- Manufacturer
- TERUMO BCT
- Product Code
- GKT
- UDI-DI
- 05020583824461
- PMA / PMN Number
- BK190332
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- 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. KAUFMAN, R. M., MARKS, D. C., FLAMAND, Y., ACKER, J. P., BROWN, B. F., OLAFSON, C., MARSCHNER, S., PANDEY, S., PAPARI, M., PETRASZKO, T., SERRANO, K., WARD, D., & BAZIN, R. (2023). RISK FACTORS FOR T-CELL LYMPHOPENIA IN FREQUENT PLATELET DONORS: THE BEST COLLABORATIVE STUDY. TRANSFUSION, 63(11), 2072¿2082. HTTPS://DOI.ORG/10.1111/TRF.17567.
THIS REPORT IS BEING FILED TO PROVIDE ADDITIONAL INFORMATION IN H.6 AND H.11. INVESTIGATION: BACKGROUND: SEVERE T-CELL LYMPHOPENIA OF UNCERTAIN CLINICAL SIGNIFICANCE HAS BEEN OBSERVED IN FREQUENT APHERESIS PLATELET DONORS. TWO COMMONLY USED PLATELETPHERESIS INSTRUMENTS ARE THE TRIMA ACCEL, WHICH USES A LEUKOREDUCTION SYSTEM (LRS) CHAMBER TO TRAP LEUKOCYTES AND THE FENWAL AMICUS, WHICH DOES NOT USE AN LRS CHAMBER. STUDY DESIGN AND METHODS: WE PERFORMED AN INTERNATIONAL, MULTICENTER, OBSERVATIONAL STUDY COMPARING T-CELL POPULATIONS IN FREQUENT PLATELET DONORS COLLECTED EXCLUSIVELY USING THE TRIMA INSTRUMENT (N = 131) OR THE AMICUS INSTRUMENT (N = 77). AGE- AND SEX-MATCHED WHOLE BLOOD DONORS (N = 126) SERVED AS CONTROLS. RESULTS: CD4+ T-CELL COUNTS 200 CELLS/L WERE FOUND IN (B)(4) OF FREQUENT TRIMA (LRS+) PLATELET DONORS, (B)(4) OF FREQUENT AMICUS (LRS) PLATELET DONORS, AND 0 WHOLE BLOOD DONORS (P .0001). CD4+ T-CELL COUNTS 200 CELLS/L WERE ONLY SEEN IN PLATELET DONORS WITH 200 LIFETIME DONATIONS. IN MULTIVARIABLE ANALYSIS, AGE, LIFETIME DONATIONS, AND INSTRUMENT (TRIMA VS. AMICUS) WERE INDEPENDENT RISK FACTORS FOR LYMPHOPENIA. IN (B)(4) TRIMA PLATELET DONORS, A PLASMA RINSEBACK PROCEDURE WAS ROUTINELY PERFORMED FOLLOWING PLATELET COLLECTIONS. NO TRIMA PLATELET DONORS RECEIVING PLASMA RINSEBACK HAD A CD4+ T-CELL COUNT 200 CELLS/L VERSUS 13/91 TRIMA PLATELET DONORS NOT RECEIVING PLASMA RINSEBACK (P = .01). DISCUSSION: RECURRENT BULK LYMPHOCYTE REMOVAL APPEARS TO CONTRIBUTE TO THE DEVELOPMENT OF T-CELL LYMPHOPENIA IN FREQUENT, LONG-TERM PLATELET DONORS. LYMPHOPENIA IS MORE COMMON WHEN AN LRS CHAMBER IS USED DURING PLATELET COLLECTION BUT CAN OCCUR WITHOUT AN LRS CHAMBER. BLOOD CENTERS USING LRS CHAMBERS CAN MITIGATE DONOR LYMPHOPENIA BY PERFORMING PLASMA RINSEBACK. SUMMARY OF TERUMO BCT PRODUCT IN RELATION TO THE JOURNAL ARTICLE: THIS INTERNATIONAL, MULTICENTER, AND OBSERVATIONAL STUDY OF PERIPHERAL BLOOD T-CELL SUBSETS AND IGG LEVELS WAS DESIGNED TO CLARIFY INDEPENDENT RISK FACTORS FOR PLATELETPHERESIS-ASSOCIATED LYMPHOPENIA. REGARDING TERUMO BCT PRODUCT, TRIMA ACCEL, INITIAL STUDIES SUGGESTED THAT LYMPHOPENIA OCCURRED IN PLATELET DONORS WITH MORE THAN (B)(4) LIFETIME DONATIONS, AND THAT LYMPHOPENIA OCCURRED PRIMARILYOR PERHAPS EXCLUSIVELYIN DONORS COLLECTED WITH THE TRIMA ACCEL INSTRUMENT (TERUMO BCT, (B)(6), CO). THE AUTHORS ENROLLED AGE AND SEX MATCHED NEW OR INFREQUENT WHOLE BLOOD DONORS TO SERVE AS CONTROLS FOR FREQUENT PLATELET DONORS. THEY THEN DIRECTLY COMPARED T-CELL COUNTS AND IGG LEVELS IN FREQUENT PLATELET DONORS WHOSE PLATELETS WERE COLLECTED WITH OR WITHOUT THE USE OF AN LRS CHAMBER. THE AUTHORS ALSO EXAMINED WHETHER PLATELETPHERESIS-ASSOCIATED LYMPHOPENIA COULD BE MITIGATED BY ROUTINELY RINSING BACK RESIDUAL WBCS TO THE DONOR IMMEDIATELY FOLLOWING TRIMA (LRS+) PLATELET COLLECTIONS. PERIPHERAL BLOOD T-CELL SUBSETS AND IGG LEVELS WERE MONITORED IN THREE GROUPS: (1) NEW OR INFREQUENT WHOLE BLOOD DONORS (CONTROL GROUP); (2) FREQUENT PLATELET DONORS COLLECTED ON THE FENWAL AMICUS INSTRUMENT (LRS-); AND (3) FREQUENT PLATELET DONORS COLLECTED ON THE TRIMA ACCEL INSTRUMENT (LRS+). PARTICIPANTS WERE ENROLLED AT (B)(4) BLOOD DONOR CENTERS IN THE UNITED STATES, CANADA, AND AUSTRALIA. FOR ALL ENROLLED WHOLE BLOOD DONORS AND 131/208 ((B)(4)) PLATELET DONORS, STUDY PARTICIPATION CONSISTED OF PROVIDING BLOOD SAMPLES AT ONE DONATION. AT A SUBSET OF SIX DONOR CENTERS, THE REMAINING 77/208 ((B)(4)) PLATELET DONORS WERE FOLLOWED PROSPECTIVELY FOR UP TO 12 MONTHS. PLATELETPHERESIS WAS PERFORMED USING THE FENWAL AMICUS INSTRUMENT OR THE TRIMA ACCEL INSTRUMENT PER ROUTINE AT EACH BLOOD DONOR CENTER. THE AUTHORS CONCLUDED THAT T-CELL LYMPHOPENIA CAN OCCUR AMONG FREQUENT, LONG-TERM PLATELET DONORS COLLECTED WITH OR WITHOUT THE USE OF AN LRS CHAMBER. FREQUENT DONATION USING THE TRIMA ACCEL INSTRUMENT (LRS+) IS MORE LIKELY TO CAUSE LYMPHOPENIA THAN FREQUENT DONATION USING THE FENWAL AMICUS INSTRUMENT (LRS-). HOWEVER, THERE WERE NO TRIMA PLATELET DONORS WHO RECEIVED A PLASMA RINSEBACK THAT HAD A CD4+ T-CELL COUNT 200 CELLS/L VERSUS THE 13/91 TRIMA PLATELET DONORS NOT RECEIVING PLASMA RINSEBACK (P = .01). DONOR AGE, CUMULATIVE DONATIONS, AND INSTRUMENT ARE ALL INDEPENDENT RISK FACTORS FOR DEVELOPING LYMPHOPENIA. DONOR CENTERS USING THE TRIMA ACCEL INSTRUMENT CAN MITIGATE LYMPHOPENIA IN THEIR DONORS BY USING THE PLASMA RINSEBACK PROCEDURE. DISPOSABLES LOT HISTORY: SINCE THIS WAS AN OBSERVATIONAL STUDY OF PERIPHERAL BLOOD T-CELL SUBSETS AND IGG LEVELS BETWEEN 2019 AND 2022, WHICH WAS DESIGNED TO CLARIFY INDEPENDENT RISK FACTORS FOR PLATELETPHERESIS-ASSOCIATED LYMPHOPENIA ON THE TRIMA ACCEL PLATFORM, THE LOT NUMBERS WERE NOT REQUESTED. THEREFORE, A DISPOSABLE LOT HISTORY SEARCH COULD NOT BE CONDUCTED. SINCE THIS WAS A JOURNAL PUBLICATION TO ASSESS THE RISK FACTORS FOR T-CELL LYMPHOPENIA IN FREQUENT PLATELET DONORS BETWEEN 2019 AND 2022, 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. INVESTIGATION IS IN PROCESS; A FOLLOW-UP REPORT WILL BE PROVIDED. KAUFMAN, R. M., MARKS, D. C., FLAMAND, Y., ACKER, J. P., BROWN, B. F., OLAFSON, C., MARSCHNER, S., PANDEY, S., PAPARI, M., PETRASZKO, T., SERRANO, K., WARD, D., & BAZIN, R. (2023). RISK FACTORS FOR TCELL LYMPHOPENIA IN FREQUENT PLATELET DONORS: THE BEST COLLABORATIVE STUDY. TRANSFUSION, 63(11), 2072 2082. HTTPS://DOI.ORG/10.1111/TRF.17567.
THIS REPORT IS BEING FILED TO PROVIDE ADDITIONAL INFORMATION IN H.6 AND H.11 AND UPDATED INFORMATION IN D.4. INVESTIGATION: BACKGROUND: SEVERE T-CELL LYMPHOPENIA OF UNCERTAIN CLINICAL SIGNIFICANCE HAS BEEN OBSERVED IN FREQUENT APHERESIS PLATELET DONORS. TWO COMMONLY USED PLATELETPHERESIS INSTRUMENTS ARE THE TRIMA ACCEL, WHICH USES A LEUKOREDUCTION SYSTEM (LRS) CHAMBER TO TRAP LEUKOCYTES AND THE FENWAL AMICUS, WHICH DOES NOT USE AN LRS CHAMBER. STUDY DESIGN AND METHODS: WE PERFORMED AN INTERNATIONAL, MULTICENTER, OBSERVATIONAL STUDY COMPARING T-CELL POPULATIONS IN FREQUENT PLATELET DONORS COLLECTED EXCLUSIVELY USING THE TRIMA INSTRUMENT (N = 131) OR THE AMICUS INSTRUMENT (N = 77). AGE- AND SEX-MATCHED WHOLE BLOOD DONORS (N = 126) SERVED AS CONTROLS. RESULTS: CD4+ T-CELL COUNTS <200 CELLS/ L WERE FOUND IN (B)(4) OF FREQUENT TRIMA (LRS+) PLATELET DONORS, (B)(4) OF FREQUENT AMICUS (LRS) PLATELET DONORS, AND (B)(4) WHOLE BLOOD DONORS (P < .0001). CD4+ T-CELL COUNTS <200 CELLS/ L WERE ONLY SEEN IN PLATELET DONORS WITH =200 LIFETIME DONATIONS. IN MULTIVARIABLE ANALYSIS, AGE, LIFETIME DONATIONS, AND INSTRUMENT (TRIMA VS. AMICUS) WERE INDEPENDENT RISK FACTORS FOR LYMPHOPENIA. IN (B)(4) TRIMA PLATELET DONORS, A PLASMA RINSEBACK PROCEDURE WAS ROUTINELY PERFORMED FOLLOWING PLATELET COLLECTIONS. NO TRIMA PLATELET DONORS RECEIVING PLASMA RINSEBACK HAD A CD4+ T-CELL COUNT <200 CELLS/ L VERSUS (B)(4) TRIMA PLATELET DONORS NOT RECEIVING PLASMA RINSEBACK (P = .01). DISCUSSION: RECURRENT BULK LYMPHOCYTE REMOVAL APPEARS TO CONTRIBUTE TO THE DEVELOPMENT OF T-CELL LYMPHOPENIA IN FREQUENT, LONG-TERM PLATELET DONORS. LYMPHOPENIA IS MORE COMMON WHEN AN LRS CHAMBER IS USED DURING PLATELET COLLECTION BUT CAN OCCUR WITHOUT AN LRS CHAMBER. BLOOD CENTERS USING LRS CHAMBERS CAN MITIGATE DONOR LYMPHOPENIA BY PERFORMING PLASMA RINSEBACK. SUMMARY OF TERUMO BCT PRODUCT IN RELATION TO THE JOURNAL ARTICLE: THIS INTERNATIONAL, MULTICENTER, AND OBSERVATIONAL STUDY OF PERIPHERAL BLOOD T-CELL SUBSETS AND IGG LEVELS WAS DESIGNED TO CLARIFY INDEPENDENT RISK FACTORS FOR PLATELETPHERESIS-ASSOCIATED LYMPHOPENIA. REGARDING TERUMO BCT PRODUCT, TRIMA ACCEL, INITIAL STUDIES SUGGESTED THAT LYMPHOPENIA OCCURRED IN PLATELET DONORS WITH MORE THAN (B)(4) LIFETIME DONATIONS, AND THAT LYMPHOPENIA OCCURRED PRIMARILY¿OR PERHAPS EXCLUSIVELY¿IN DONORS COLLECTED WITH THE TRIMA ACCEL INSTRUMENT (TERUMO BCT, (B)(6), CO). THE AUTHORS ENROLLED AGE AND SEX MATCHED NEW OR INFREQUENT WHOLE BLOOD DONORS TO SERVE AS CONTROLS FOR FREQUENT PLATELET DONORS. THEY THEN DIRECTLY COMPARED T-CELL COUNTS AND IGG LEVELS IN FREQUENT PLATELET DONORS WHOSE PLATELETS WERE COLLECTED WITH OR WITHOUT THE USE OF AN LRS CHAMBER. THE AUTHORS ALSO EXAMINED WHETHER PLATELETPHERESIS-ASSOCIATED LYMPHOPENIA COULD BE MITIGATED BY ROUTINELY RINSING BACK RESIDUAL WBCS TO THE DONOR IMMEDIATELY FOLLOWING TRIMA (LRS+) PLATELET COLLECTIONS. PERIPHERAL BLOOD T-CELL SUBSETS AND IGG LEVELS WERE MONITORED IN THREE GROUPS: (B)(4) NEW OR INFREQUENT WHOLE BLOOD DONORS (CONTROL GROUP); (B)(4) FREQUENT PLATELET DONORS COLLECTED ON THE FENWAL AMICUS INSTRUMENT (LRS-); AND (B)(4) FREQUENT PLATELET DONORS COLLECTED ON THE TRIMA ACCEL INSTRUMENT (LRS+). PARTICIPANTS WERE ENROLLED AT (B)(4) BLOOD DONOR CENTERS IN THE UNITED STATES, CANADA, AND AUSTRALIA. FOR ALL ENROLLED WHOLE BLOOD DONORS AND (B)(4) PLATELET DONORS, STUDY PARTICIPATION CONSISTED OF PROVIDING BLOOD SAMPLES AT ONE DONATION. AT A SUBSET OF (B)(4) DONOR CENTERS, THE REMAINING (B)(4) PLATELET DONORS WERE FOLLOWED PROSPECTIVELY FOR UP TO 12 MONTHS. PLATELETPHERESIS WAS PERFORMED USING THE FENWAL AMICUS INSTRUMENT OR THE TRIMA ACCEL INSTRUMENT PER ROUTINE AT EACH BLOOD DONOR CENTER. THE AUTHORS CONCLUDED THAT T-CELL LYMPHOPENIA CAN OCCUR AMONG FREQUENT, LONG-TERM PLATELET DONORS COLLECTED WITH OR WITHOUT THE USE OF AN LRS CHAMBER. FREQUENT DONATION USING THE TRIMA ACCEL INSTRUMENT (LRS+) IS MORE LIKELY TO CAUSE LYMPHOPENIA THAN FREQUENT DONATION USING THE FENWAL AMICUS INSTRUMENT (LRS-). HOWEVER, THERE WERE NO TRIMA PLATELET DONORS WHO RECEIVED A PLASMA RINSEBACK THAT HAD A CD4+ T-CELL COUNT <200 CELLS/ L VERSUS THE (B)(4) TRIMA PLATELET DONORS NOT RECEIVING PLASMA RINSEBACK (P = .01). DONOR AGE, CUMULATIVE DONATIONS, AND INSTRUMENT ARE ALL INDEPENDENT RISK FACTORS FOR DEVELOPING LYMPHOPENIA. DONOR CENTERS USING THE TRIMA ACCEL INSTRUMENT CAN MITIGATE LYMPHOPENIA IN THEIR DONORS BY USING THE PLASMA RINSEBACK PROCEDURE. SINCE THIS WAS AN OBSERVATIONAL STUDY OF PERIPHERAL BLOOD T-CELL SUBSETS AND IGG LEVELS BETWEEN 2019 AND 2022, WHICH WAS DESIGNED TO CLARIFY INDEPENDENT RISK FACTORS FOR PLATELETPHERESIS-ASSOCIATED LYMPHOPENIA ON THE TRIMA ACCEL PLATFORM, THE LOT NUMBERS WERE NOT REQUESTED. THEREFORE, A DISPOSABLE LOT HISTORY SEARCH COULD NOT BE CONDUCTED. SINCE THIS WAS A JOURNAL PUBLICATION TO ASSESS THE RISK FACTORS FOR T-CELL LYMPHOPENIA IN FREQUENT PLATELET DONORS BETWEEN 2019 AND 2022, 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. ROOT CAUSE: A ROOT CAUSE ASSESSMENT WAS PERFORMED FOR THE REPORTED T-CELL LYMPHOPENIA. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED, HOWEVER DONOR AGE, DONOR PHYSIOLOGY, CUMULATIVE DONATIONS, AND THE INSTRUMENT USED WERE ALL DETERMINED BY THE AUTHORS TO BE INDEPENDENT RISK FACTORS FOR DEVELOPING LYMPHOPENIA. AS THE TRIMA INSTRUMENT USES A LEUKOCYTE REDUCTION SYSTEM (LRS) CHAMBER TO TRAP WHITE BLOOD CELLS (WBCS), YIELDING LEUKOREDUCED PLATELET UNITS, IT WAS CONCLUDED BY THE AUTHORS THAT DONOR CENTERS USING THE TRIMA ACCEL INSTRUMENT CAN MITIGATE LYMPHOPENIA IN THEIR DONORS BY USING THE PLASMA RINSEBACK PROCEDURE. CITATION: KAUFMAN, R. M., MARKS, D. C., FLAMAND, Y., ACKER, J. P., BROWN, B. F., OLAFSON, C., MARSCHNER, S., PANDEY, S., PAPARI, M., PETRASZKO, T., SERRANO, K., WARD, D., & BAZIN, R. (2023). RISK FACTORS FOR T-CELL LYMPHOPENIA IN FREQUENT PLATELET DONORS: THE BEST COLLABORATIVE STUDY. TRANSFUSION, 63(11), 2072¿2082. HTTPS://DOI.ORG/10.1111/TRF.17567.
PER JOURNAL ARTICLE "RISK FACTORS FOR T-CELL LYMPHOPENIA IN FREQUENT PLATELET DONORS: THE BEST COLLABORATIVE STUDY" BY KAUFMAN, R. M., MARKS, D. C., FLAMAND, Y., ACKER, J. P., BROWN, B. F., OLAFSON, C., MARSCHNER, S., PANDEY, S., PAPARI, M., PETRASZKO, T., SERRANO, K., WARD, D., & BAZIN, R. PER THE ARTICLE, SEVERE T-CELL LYMPHOPENIA OF UNCERTAIN CLINICAL SIGNIFICANCE HAS BEEN OBSERVED IN FREQUENT APHERESIS PLATELET DONORS. TWO COMMONLY USED PLATELETPHERESIS INSTRUMENTS ARE THE TRIMA ACCEL, WHICH USES A LEUKOREDUCTION SYSTEM (LRS) CHAMBER TO TRAP LEUKOCYTES AND THE FENWAL AMICUS, WHICH DOES NOT USE AN LRS CHAMBER. STUDY DESIGN AND METHODS: WE PERFORMED AN INTERNATIONAL, MULTICENTER, OBSERVATIONAL STUDY COMPARING T-CELL POPULATIONS IN FREQUENT PLATELET DONORS COLLECTED EXCLUSIVELY USING THE TRIMA INSTRUMENT (N = 131) OR THE AMICUS INSTRUMENT (N = 77). AGE- AND SEX-MATCHED WHOLE BLOOD DONORS (N = 126) SERVED AS CONTROLS. 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 COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.
PER JOURNAL ARTICLE "RISK FACTORS FOR T-CELL LYMPHOPENIA IN FREQUENT PLATELET DONORS: THE BEST COLLABORATIVE STUDY" BY KAUFMAN, R. M., MARKS, D. C., FLAMAND, Y., ACKER, J. P., BROWN, B. F., OLAFSON, C., MARSCHNER, S., PANDEY, S., PAPARI, M., PETRASZKO, T., SERRANO, K., WARD, D., & BAZIN, R. PER THE ARTICLE, SEVERE T-CELL LYMPHOPENIA OF UNCERTAIN CLINICAL SIGNIFICANCE HAS BEEN OBSERVED IN FREQUENT APHERESIS PLATELET DONORS. TWO COMMONLY USED PLATELETPHERESIS INSTRUMENTS ARE THE TRIMA ACCEL, WHICH USES A LEUKOREDUCTION SYSTEM (LRS) CHAMBER TO TRAP LEUKOCYTES AND THE FENWAL AMICUS, WHICH DOES NOT USE AN LRS CHAMBER. STUDY DESIGN AND METHODS: WE PERFORMED AN INTERNATIONAL, MULTICENTER, OBSERVATIONAL STUDY COMPARING T-CELL POPULATIONS IN FREQUENT PLATELET DONORS COLLECTED EXCLUSIVELY USING THE TRIMA INSTRUMENT (N = 131) OR THE AMICUS INSTRUMENT (N = 77). AGE- AND SEX-MATCHED WHOLE BLOOD DONORS (N = 126) SERVED AS CONTROLS. 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 COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.
PER JOURNAL ARTICLE "RISK FACTORS FOR T-CELL LYMPHOPENIA IN FREQUENT PLATELET DONORS: THE BEST COLLABORATIVE STUDY" BY KAUFMAN, R. M., MARKS, D. C., FLAMAND, Y., ACKER, J. P., BROWN, B. F., OLAFSON, C., MARSCHNER, S., PANDEY, S., PAPARI, M., PETRASZKO, T., SERRANO, K., WARD, D., & BAZIN, R. PER THE ARTICLE, SEVERE T-CELL LYMPHOPENIA OF UNCERTAIN CLINICAL SIGNIFICANCE HAS BEEN OBSERVED IN FREQUENT APHERESIS PLATELET DONORS. TWO COMMONLY USED PLATELETPHERESIS INSTRUMENTS ARE THE TRIMA ACCEL, WHICH USES A LEUKOREDUCTION SYSTEM (LRS) CHAMBER TO TRAP LEUKOCYTES AND THE FENWAL AMICUS, WHICH DOES NOT USE AN LRS CHAMBER. STUDY DESIGN AND METHODS: WE PERFORMED AN INTERNATIONAL, MULTICENTER, OBSERVATIONAL STUDY COMPARING T-CELL POPULATIONS IN FREQUENT PLATELET DONORS COLLECTED EXCLUSIVELY USING THE TRIMA INSTRUMENT (N = 131) OR THE AMICUS INSTRUMENT (N = 77). AGE- AND SEX-MATCHED WHOLE BLOOD DONORS (N = 126) SERVED AS CONTROLS. 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 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 |
|---|---|---|---|---|---|---|---|
| 1656071 | TRIMA ACCEL | TRIMA PLATELET+SAMPLER, PLASMA, RBC SET | GKT | TERUMO BCT | 05020583824461 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |