MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA PLATELET+SAMPLER, PLASMA, RBC

Model Number 82446

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Anemia (1706)

Event Date 11/30/2022

Event Type  Injury  

Manufacturer Narrative

Lot number and expiry are not available at this time.Article citation: chin, l.T.,woon, j.Y.,kuo, s.W.,lu, s.C.(2022).Decreased levels of ferritin, mild thrombocytosis, and increased erythropoietin are sequential events among frequent plateletpheresis donors: implication for a ferritin screen.Transfus apher sci.2022:103501 investigation is in process.A follow up report will be provided.

Event Description

The journal article, 'decreased levels of ferritin, mild thrombocytosis, and increased erythropoietin are sequential events among frequent plateletpheresis donors: implication for a ferritin screen' discusses a study on the impacts to donors of frequent plateletpheresis.Levels of erythropoietin (epo), hemoglobin (hb) and ferritin were analyzed in double-unit (500 ml whole blood or 6 × 1011 apheresis platelets) donations in three male cohorts, aged 20-60 years, with identifiers of first-time whole blood donors (n = 30), first-time platelet donors transited from maximal whole blood to apheresis (n = 30) and frequent donors subjected to extreme plateletpheresis (n = 90), respectively.This study incorporates donors who donate almost the maximal 24 times per year.Findings demonstrate that increased number and frequency of apheresis donations increased epo and decreased ferritin levels.This suggests that regular apheresis donations may lead to reduced body iron stores or a higher prevalence of iron deficiency.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.The apheresis sets are not available for return for evaluation.

Event Description

The journal article, 'decreased levels of ferritin, mild thrombocytosis, and increased erythropoietin are sequential events among frequent plateletpheresis donors: implication for a ferritin screen' discusses a study on the impacts to donors of frequent plateletpheresis.Levels of erythropoietin (epo), hemoglobin (hb) and ferritin were analyzed in double-unit (500 ml whole blood or 6 × 1011 apheresis platelets) donations in three male cohorts, aged 20-60 years, with identifiers of first-time whole blood donors (n = 30), first-time platelet donors transited from maximal whole blood to apheresis (n = 30) and frequent donors subjected to extreme plateletpheresis (n = 90), respectively.This study incorporates donors who donate almost the maximal 24 times per year.Findings demonstrate that increased number and frequency of apheresis donations increased epo and decreased ferritin levels.This suggests that regular apheresis donations may lead to reduced body iron stores or a higher prevalence of iron deficiency.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.The apheresis sets are not available for return for evaluation.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.11.Investigation: the association between blood loss and blood residual was investigated by comparing and analyzing the weight of disposable equipment used with trima accel (terumo bct, tokyo, japan) and fenwal amicus (fresenius kabi, bad homburg vor der hohe, germany) before and after plateletpheresis donation.The volume of the disposable equipment was back-calculated by dividing the equipment weight (g) with the specific gravity for whole blood (1.06 g/ml).Based on the volume measured above, the blood loss in the process of plateletpheresis donation was estimated by the following formula: total blood loss (ml) = volume of blood residual in the disposable equipment (ml) + 32 ml of extra blood loss (6 ml for complete blood count, 6 ml for general biochemistry test, 6 ml for transfusion transmissible disease test, 6 ml for sample archive, and 8 ml of residual blood in the sample bag).Red blood cell loss (ml) = total blood loss (ml) × hct.Correlation between ferritin with epo and plt of plateletpheresis donors: the pattern of decreased ferritin was observed in all four apheresis populations, allowing us to further evaluate the correlation of ferritin with epo and plt in a side by side manner.Based on pearson correlation test, fig.1 indicates a significant inverse correlation between epo and ferritin (r = - 0.224; p < 0.05) among apheresis donors, whereas fig.2 shows a non-significant inverse correlation between plt and ferritin (r = - 0.109; p > 0.05) in them.Additionally, results were divided into two groups according to the median value of epo.The mean concentrations of ferritin in the epo below-median (low epo) and above-median (high epo) groups were 51.1 ± 38.3 ¿g/l and 35.3 ± 47.7 ¿g/l, respectively.Changes in ferritin, epo and plt values in first-time plateletpheresis donors: to examine more effective the changes in ferritin, epo and the amount of platelets over time, these parameters were monitored every 3 months over a period of one year in the pf group.Table 5 denotes a significant drop of ferritin once the donors become in earnest to minimize their intervals.It also shows a gradual decrease in ferritin levels as the number of donations increased; however, the value was not differenced significantly compared to the first time of donation (baseline).At month 12, higher epo concentrations can be observed later than decreased ferritin (mean 13.0 ± 5.4 miu/ml), but no statistically significant differences (p = 0.20) were found.This analysis revealed that the ferritin levels decreased from months 3, plt decreased only slightly at month 3 and increased thereafter, while epo concentrations were below baseline for 9 months but increased abruptly at month 12.Blood loss during plateletpheresis donation: the blood loss volume was calculated by subtracting the volume of acd-a from the volume difference of the disposable equipment before and after plateletpheresis donation.This analysis revealed total blood loss of 82.1 ml and 83.7 ml, which were back-calculated to red blood cell loss (45 %) of 36.9 ml and 38.3 ml, respectively.There were no significant differences between the two types of apheresis instruments.Donor selection and screening are the cornerstones of blood transfusion safety and it is equally important to protect the health of both the donor and the recipient.Apheresis donors may pay attention to and act accordingly their eating behavior as well as consistently exercise in order to make their respective donations regularly, which also help to control their weight; however, frequent plateletphereses from earnest donors who donate more than 15 times annually are at risk of iron deficiency.Here, the authors examined the effect of plateletpheresis donation on blood homeostasis in both longitudinal and cross-sectional studies, and our findings suggest that frequent apheresis donation leads sequentially to a decrease in ferritin, a rise in plt, and an increase in epo.These findings suggest that pre-donation hb screening is inadequate, and that ferritin measurement and iron supplementation, as well as other strategies, such as extended inter-donation intervals, are recommended to reduce the risk of iron deficiency in repeat plateletpheresis donors.A risk assessment was conducted for this failure.According to aabb tech manual 20th edition, donors, particularly frequent donors, may develop iron deficient erythropoiesis or advance to frank absence of iron stores.Without iron supplementation, two-thirds of donors may not recover iron stores even after 168 days (24 weeks).Recent studies have shown the benefit of iron supplementation in improving iron stores and hemoglobin in these donors.The amount of elemental iron found in an over-the-counter daily multivitamin is typically 19 mg; iron tablets available over the counter may contain 38 mg of elemental iron.Either can be an effective supplement for blood donors with adverse effects indistinguishable from placebo.Aabb standard 5.7.4.21 requires that platelets collected by apheresis contain at least 3 × 1011 platelets in 90% of units tested.Units containing less than 3.0 × 1011 platelets should be labeled with the actual platelet count.Apheresis platelet donors may donate more frequently than wb donors but must meet all other criteria for wb donation.The interval between donations should be at least 2 days, and donors should not undergo plateletpheresis more than twice in a week or 24 times in a rolling 12-month period.Since this was a journal publication to assess the decreased levels of ferritin, mild thrombocytosis, and increased erythropoietin among frequent plateletpheresis donors in 150 subjects over a seven year period, 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: based on the available information within the journal article, a definitive root cause could not be determined.The journal mentioned allegations of iron deficiency, elevated platelet count and elevated epo levels.Possible causes for these events associated with trima include but are not limited to donor physiology and/or frequency of donation.Article citation: chin, l.T.,woon, j.Y.,kuo, s.W.,lu, s.C.(2022).Decreased levels of ferritin, mild thrombocytosis, and increased erythropoietin are sequential events among frequent plateletpheresis donors: implication for a ferritin screen.Transfus apher sci.2022: (b)(4).

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA PLATELET+SAMPLER, PLASMA, RBC
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer (Section G): TERUMO BCT; 10810 w. collins ave; lakewood CO 80215
• Manufacturer Contact: scot hilden ; 10810 w. collins ave; lakewood, CO 80215
• MDR Report Key: 16055593
• MDR Text Key: 306239490
• Report Number: 1722028-2022-00425
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583824461
• UDI-Public: 05020583824461
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: BK190332
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 82446
• Device Catalogue Number: 82446
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other