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

TERUMO BCT TRIMA ACCEL; TRIMA PLATELET+SAMPLER, PLASMA, RBC SET

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Model Number 82446

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Local Reaction (2035)

Event Date 11/30/2021

Event Type Injury

Event Description

In the article, 'the impact of immediate adverse donation reactions on the return of volunteers undergoing platelet apheresis,' a study was done with a sample of 4108 consecutive platelet apheresis donors seen from august 2016 through june 2019, to determine whether immediate adverse reactions were associated with returning for a subsequent platelet apheresis donation within a 12-month period.Per the article, an immediate adverse reaction occurred in 312 (7.6%) donors; 98.5% were mild, and 0.3% were severe.Platelet donations were used trima accel version 6.0 (lakewood, usa) from april to june 2019.No donor received prophylactic calcium, and all were monitored for adverse reactions by the apheresis operators.Exact patient (donor) information, details regarding the adverse reactions, and any medical intervention performed, were not provided in the article, therefore this report is being filed as a summary.Per the article, 'the majority were male (75%), aged 30 to 49 years (52.6%)' the device is not available for return.

Manufacturer Narrative

Event Description

In the article, 'the impact of immediate adverse donation reactions on the return of volunteers undergoing platelet apheresis', a study was done with a sample of 4108 consecutive platelet apheresis donors seen from august 2016 through june 2019, to determine whether immediate adverse reactions were associated with returning for a subsequent platelet apheresis donation within a 12-month period.Per the article, an immediate adverse reaction occurred in 312 (7.6%) donors; 98.5% were mild, and 0.3% were severe.Platelet donations were used trima accel version 6.0 (lakewood, usa) from april to june 2019.No donor received prophylactic calcium, and all were monitored for adverse reactions by the apheresis operators.Exact patient (donor) information, details regarding the adverse reactions, and any medical intervention performed, were not provided in the article, therefore this report is being filed as a summary.Per the article, 'the majority were male (75%), aged 30 to 49 years (52.6%)' the device is not available for return.

Manufacturer Narrative

This report is being filed to provide additional information in h.10.Investigation: per the article, adverse reactions were classified according to the 2015 brazilian national hemovigilance guidelines.Generally, the brazilian guidelines are based on the standard for surveillance of complications related to blood donation from the international society of blood transfusion working party on haemovigilance.Adverse reactions to blood donation are classified according to time of the occurrence, as either immediate (signs/symptoms occurred before the donor has left the donation site) or delayed (signs/symptoms occurred after the blood donor has left the site donation); according to the scope of the signs/symptoms, as either local (hematoma, arterial puncture, delayed bleeding, nerve irritation, nerve injury, tendon injury, painful arm, thrombophlebitis, and local allergy) or systemic (vasovagal reaction, hypotensive reaction, citrate toxicity, hemolysis, generalized allergic reaction, and air embolism); and according to the severity of the complications, as mild (when there was a sign/local symptom, with no pain that stops donor from performing his or her habitual activities or that persists until two weeks, or systemic reactions with subjective symptoms with rapid recovery < 30 minutes, such as dizziness, nausea, discomfort, pallor), moderate (when there was local symptom that stops donor from performing his or her habitual activities or that persists for more than two weeks, or systemic reactions with objective symptoms, such as loss of consciousness, hypotension with need for volume replacement and tetany), or severe (when there was need for hospitalization due to the reaction, or the need for an intervention to prevent permanent damage or impairment of a body function, or to prevent death, or when there were symptoms that persisted for more than one year after donation).An immediate adverse reaction occurred in 312 (7.6%) donors; 98.5% were mild, and 0.3% were severe.Of the original 4108 platelet apheresis donors, only 3211 (72.3%) returned for a subsequent donation within 12 months.Experiencing an immediate adverse reaction during the donation process significantly decreased the return rate for a subsequent donation [hr= 0.74 (0.63¿0.87)], especially among female donors [hr= 0.70 (0.53¿0.93)], donors aged < 30 years [hr= 0.71 (0.54¿0.94)], with a high school educational level [0.63 (0.49¿0.81)], donors donating for the first time [hr= 0.73 (0.59¿0.90)], and repeat donors with a previous platelet apheresis donation more than 180 days prior [hr= 0.68 (0.50¿0.93)].Adverse reactions were classified according to the 2015 brazilian national hemovigilance guidelines.Adverse reactions to blood donation are classified according to time of the occurrence, as either immediate (signs/symptoms occurred before the donor has left the donation site) or delayed (signs/symptoms occurred after the blood donor has left the site donation); according to the scope of the signs/symptoms, as either local (hematoma, arterial puncture, delayed bleeding, nerve irritation, nerve injury, tendon injury, painful arm, thrombophlebitis, and local allergy) or systemic (vasovagal reaction, hypotensive reaction, citrate toxicity, hemolysis, generalized allergic reaction, and air embolism); and according to the severity of the complications, as mild (when there was a sign/local symptom, with no pain that stops donor from performing his or her habitual activities or that persists until two weeks, or systemic reactions with subjective symptoms with rapid recovery < 30 minutes, such as dizziness, nausea, discomfort, pallor), moderate (when there was local symptom that stops donor from performing his or her habitual activities or that persists for more than two weeks, or systemic reactions with objective symptoms, such as loss of consciousness, hypotension with need for volume replacement and tetany), or severe (when there was need for hospitalization due to the reaction, or the need for an intervention to prevent permanent damage or impairment of a body function, or to prevent death, or when there were symptoms that persisted for more than one year after donation).During the period from august 1, 2016, through june 29, 2019, there were a total of 11343 platelet apheresis donations made by 4332 donors.Among these donors, 224 (5.2%) were excluded because they were replacement donors, or showed incomplete data or data entry errors, which left us 4108 donors for consideration as index donations.The results from propensity score matching pair selection led to in 312 donors in the adverse event group and 624 in the no adverse reaction group (supplemental table 1).A total of 322 immediate adverse reactions occurred in 312 (7.6%) donors: 98.5% were mild, 1.2% were moderate, and 0.3% were severe.On follow-up, 3211 platelet apheresis donors (78.2%) returned to make a subsequent donation.Immediate adverse reactions were most prevalent among female donors, among donors with one to three previous donations, and among donors for whom the previous donation was more than 180 days prior (table 1).Experiencing an immediate adverse reaction during the donation process significantly decreased the return rate for a subsequent donation [hr=0.74 (0.63-0.87)], especially among female donors [hr=0.70 (0.53-0.93)], donors aged <30 years [hr=0.71 (0.54- 0.94)], donors with a high school educational level [0.63 (0.49-0.81)], donors with a bmi>30kg/m2 [hr=0.70 (0.49-0.99)], donors donating for the first time [0.73 (0.59- 0.90)] and donors with a previous donation more than 180 days prior [0.68 (0.50-0.93)] (table 2).Article citation: cássio lins gil de farias, lucas bassolli de oliveira alves, alfredo mendrone-junior, cyntia de araújo arrais, amanda duran, vanderson rocha and cesar de almeida-neto, the impact of immediate adverse donation reactions on the return of volunteers undergoing platelet apheresis.Adverse reactions and return of platelet apheresis donors, transfusion and apheresis science, (2021) doi:https://doi.Org/10.1016/j.Transci.2022.103424 since this is a study which evaluated the impact of immediate adverse donation reactions on the return of volunteers undergoing platelet apheresis using both amicus and trima from august 2016 through june 2019, the lot numbers were not provided; therefore, a dhr search could not be conducted for this specific incident.All lots must meet acceptance criteria for release.The reported adverse events are common side effects of apheresis donations.According to aabb technical manual 16th edition, on donor follow-up surveys, minor reactions, such as a dime-sized hematoma at the phlebotomy site, are reported by as many as one-third of all donor.Bruise or hematoma are common after phlebotomy but generally do not prevent donor return.Adverse reactions 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 34 donors.Vasovagal reaction complex includes dizziness, sweating, nausea, vomiting, weakness, apprehension, pallor, hypotension, and bradycardia.In severe cases, syncope and convulsions may be observed.The pulse rate is often low during vasovagal reactions while the rate is often high during volume depletion.Some donors with severe reactions or those with prolonged recovery times may need short-term observation, intravenous fluid administration in the emergency room, or both.Nonsyncopal reactions are 25 times more common than syncopal reactions.About 15% of reactions occur away from the donation site and usually within 1 hour of donation.First-time donors and females are more likely to report fatigue after donation.Nerve injuries may be unavoidable because nerve cannot be palpated.In 40% of cases of nerve injuries, phlebotomy was performed without any difficulty.Donors may complain of sensory changes away from the phlebotomy site, such as in the forearm, wrist, hand, upper arm, or shoulder.Those injuries are almost always transient, and recovery is almost always seen; however, in 7% of injured donors, it may take 3 to 9 months.In severe cases, a neurologist referral may be indicated.According to anticoagulation techniques in apheresis: from heparin to citrate and beyond, citrate related complications have been reported to occur in: 1.2% of donors during voluntary donation, 7.8% of patients undergoing therapeutic plasma exchange procedures, and 48% of patients undergoing large volume leukapheresis during peripheral blood progenitor cell collection.Symptoms of hypocalcemia and other citrate-induced metabolic abnormalities affect neuromuscular and cardiac function and range in severity from mild dysesthesias (most common) to tetany, seizures, and cardiac arrhythmias.Since this is a study which evaluated the impact of immediate adverse donation reactions on the return of volunteers undergoing platelet apheresis using both amicus and trima from august 2016 through june 2019, the lot numbers were not provided; therefore, a disposable lot history search could not be conducted.Since this is a study which evaluated the impact of immediate adverse donation reactions on the return of volunteers undergoing platelet apheresis using both amicus and trima from august 2016 through june 2019, the disposable sets were not available for return.Investigation is in process.A follow up report will be provided.

Manufacturer Narrative

Event Description

In the article, 'the impact of immediate adverse donation reactions on the return of volunteers undergoing platelet apheresis', a study was done with a sample of (b)(4)consecutive platelet apheresis donors seen from (b)(6) 2016 through (b)(6) 2019, to determine whether immediate adverse reactions were associated with returning for a subsequent platelet apheresis donation within a 12-month period.Per the article, an immediate adverse reaction occurred in (b)(4) donors; (b)(4) were mild, and (b)(4) were severe.Platelet donations were used trima accel version 6.0 ((b)(6), usa) from (b)(6) 2019.No donor received prophylactic calcium, and all were monitored for adverse reactions by the apheresis operators.Exact patient (donor) information, details regarding the adverse reactions, and any medical intervention performed, were not provided in the article, therefore this report is being filed as a summary.Per the article, 'the majority were male (b)(4) the device is not available for return.

Manufacturer Narrative

Investigation: per the article, adverse reactions were classified according to the 2015 brazilian national hemovigilance guidelines.Generally, the brazilian guidelines are based on the standard for surveillance of complications related to blood donation from the international society of blood transfusion working party on haemovigilance.Adverse reactions to blood donation are classified according to time of the occurrence, as either immediate (signs/symptoms occurred before the donor has left the donation site) or delayed (signs/symptoms occurred after the blood donor has left the site donation); according to the scope of the signs/symptoms, as either local (hematoma, arterial puncture, delayed bleeding, nerve irritation, nerve injury, tendon injury, painful arm, thrombophlebitis, and local allergy) or systemic (vasovagal reaction, hypotensive reaction, citrate toxicity, hemolysis, generalized allergic reaction, and air embolism); and according to the severity of the complications, as mild (when there was a sign/local symptom, with no pain that stops donor from performing his or her habitual activities or that persists until two weeks, or systemic reactions with subjective symptoms with rapid recovery 30 minutes, such as dizziness, nausea, discomfort, pallor), moderate (when there was local symptom that stops donor from performing his or her habitual activities or that persists for more than two weeks, or systemic reactions with objective symptoms, such as loss of consciousness, hypotension with need for volume replacement and tetany), or severe (when there was need for hospitalization due to the reaction, or the need for an intervention to prevent permanent damage or impairment of a body function, or to prevent death, or when there were symptoms that persisted for more than one year after donation).An immediate adverse reaction occurred in 312 (7.6%) donors; 98.5% were mild, and 0.3% were severe.Of the original 4108 platelet apheresis donors, only 3211 (72.3%) returned for a subsequent donation within 12 months.Experiencing an immediate adverse reaction during the donation process significantly decreased the return rate for a subsequent donation [hr= 0.74 (0.63¿0.87)], especially among female donors [hr= 0.70 (0.53¿0.93)], donors aged < 30 years [hr= 0.71 (0.54¿0.94)], with a high school educational level [0.63 (0.49¿0.81)], donors donating for the first time [hr= 0.73 (0.59¿0.90)], and repeat donors with a previous platelet apheresis donation more than 180 days prior [hr= 0.68 (0.50¿0.93)].Adverse reactions were classified according to the 2015 brazilian national hemovigilance guidelines.Adverse reactions to blood donation are classified according to time of the occurrence, as either immediate (signs/symptoms occurred before the donor has left the donation site) or delayed (signs/symptoms occurred after the blood donor has left the site donation); according to the scope of the signs/symptoms, as either local (hematoma, arterial puncture, delayed bleeding, nerve irritation, nerve injury, tendon injury, painful arm, thrombophlebitis, and local allergy) or systemic (vasovagal reaction, hypotensive reaction, citrate toxicity, hemolysis, generalized allergic reaction, and air embolism); and according to the severity of the complications, as mild (when there was a sign/local symptom, with no pain that stops donor from performing his or her habitual activities or that persists until two weeks, or systemic reactions with subjective symptoms with rapid recovery < 30 minutes, such as dizziness, nausea, discomfort, pallor), moderate (when there was local symptom that stops donor from performing his or her habitual activities or that persists for more than two weeks, or systemic reactions with objective symptoms, such as loss of consciousness, hypotension with need for volume replacement and tetany), or severe (when there was need for hospitalization due to the reaction, or the need for an intervention to prevent permanent damage or impairment of a body function, or to prevent death, or when there were symptoms that persisted for more than one year after donation).During the period from august 1, 2016, through june 29, 2019, there were a total of 11343 platelet apheresis donations made by 4332 donors.Among these donors, 224 (5.2%) were excluded because they were replacement donors, or showed incomplete data or data entry errors, which left us 4108 donors for consideration as index donations.The results from propensity score matching pair selection led to in 312 donors in the adverse event group and 624 in the no adverse reaction group (supplemental table 1).A total of 322 immediate adverse reactions occurred in 312 (7.6%) donors: 98.5% were mild, 1.2% were moderate, and 0.3% were severe.On follow-up, 3211 platelet apheresis donors (78.2%) returned to make a subsequent donation.Immediate adverse reactions were most prevalent among female donors, among donors with one to three previous donations, and among donors for whom the previous donation was more than 180 days prior (table 1).Experiencing an immediate adverse reaction during the donation process significantly decreased the return rate for a subsequent donation [hr=0.74 (0.63-0.87)], especially among female donors [hr=0.70 (0.53-0.93)], donors aged < 30 years [hr=0.71 (0.54- 0.94)], donors with a high school educational level [0.63 (0.49-0.81)], donors with a bmi > 30kg/m2 [hr=0.70 (0.49-0.99)], donors donating for the first time [0.73 (0.59- 0.90)] and donors with a previous donation more than 180 days prior [0.68 (0.50-0.93)] (table 2).Article citation: cássio lins gil de farias, lucas bassolli de oliveira alves, alfredo mendrone-junior, cyntia de araújo arrais, amanda duran, vanderson rocha and cesar de almeida-neto, the impact of immediate adverse donation reactions on the return of volunteers undergoing platelet apheresis.Adverse reactions and return of platelet apheresis donors, transfusion and apheresis science, (2021).Doi:https://doi.Org/10.1016/j.Transci.2022.103424.Since this is a study which evaluated the impact of immediate adverse donation reactions on the return of volunteers undergoing platelet apheresis using both amicus and trima from august 2016 through june 2019, the lot numbers were not provided; therefore, a dhr search could not be conducted for this specific incident.All lots must meet acceptance criteria for release.The reported adverse events are common side effects of apheresis donations.According to aabb technical manual 16th edition, on donor follow-up surveys, minor reactions, such as a dime-sized hematoma at the phlebotomy site, are reported by as many as one-third of all donor.Bruise or hematoma are common after phlebotomy but generally do not prevent donor return.Adverse reactions 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 34 donors.Vasovagal reaction complex includes dizziness, sweating, nausea, vomiting, weakness, apprehension, pallor, hypotension, and bradycardia.In severe cases, syncope and convulsions may be observed.The pulse rate is often low during vasovagal reactions while the rate is often high during volume depletion.Some donors with severe reactions or those with prolonged recovery times may need short-term observation, intravenous fluid administration in the emergency room, or both.Nonsyncopal reactions are 25 times more common than syncopal reactions.About 15% of reactions occur away from the donation site and usually within 1 hour of donation.First-time donors and females are more likely to report fatigue after donation.Nerve injuries may be unavoidable because nerve cannot be palpated.In 40% of cases of nerve injuries, phlebotomy was performed without any difficulty.Donors may complain of sensory changes away from the phlebotomy site, such as in the forearm, wrist, hand, upper arm, or shoulder.Those injuries are almost always transient, and recovery is almost always seen; however, in 7% of injured donors, it may take 3 to 9 months.In severe cases, a neurologist referral may be indicated.According to anticoagulation techniques in apheresis: from heparin to citrate and beyond, citrate related complications have been reported to occur in: 1.2% of donors during voluntary donation, 7.8% of patients undergoing therapeutic plasma exchange procedures, and 48% of patients undergoing large volume leukapheresis during peripheral blood progenitor cell collection.Symptoms of hypocalcemia and other citrate-induced metabolic abnormalities affect neuromuscular and cardiac function and range in severity from mild dysesthesias (most common) to tetany, seizures, and cardiac arrhythmias.Since this is a study which evaluated the impact of immediate adverse donation reactions on the return of volunteers undergoing platelet apheresis using both amicus and trima from august 2016 through june 2019, the lot numbers were not provided; therefore, a disposable lot history search could not be conducted.Root cause: 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 patient physiology, the patient's disease state, 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.The other reported adverse events 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 vascular injury could not be determined.Possible root causes include but are not limited to: the donor's access was not properly positioned.Arm movement causing the dislocation of the access.Poor phlebotomy technique.Return flow rate was too high a definitive root cause of the alleged allergic reaction could not be determined.Possible causes include but are not limited to: donor sensitivity to the components in the disposable set - donor sensitivity to the ethylene oxide used to sterilize the disposable set.

Event Description

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Brand Name

TRIMA ACCEL

Type of Device

TRIMA PLATELET+SAMPLER, PLASMA, RBC SET

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

MDR Report Key

14114126

MDR Text Key

289295811

Report Number

1722028-2022-00113

Device Sequence Number

Product Code

GKT

UDI-Device Identifier

05020583824461

UDI-Public

05020583824461

Combination Product (y/n)

Reporter Country Code

PMA/PMN Number

BK190332

Number of Events Reported

Summary Report (Y/N)

Report Source

Manufacturer

Source Type

Literature,Health Professional

Reporter Occupation

Other Health Care Professional

Type of Report

Initial,Followup,Followup,Followup

Report Date

04/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

Is this an Adverse Event Report?

Yes

Is this a Product Problem Report?

Device Operator

Health Professional

Device Model Number

82446

Device Catalogue Number

82446

Was Device Available for Evaluation?

Is the Reporter a Health Professional?

Yes

Initial Date Manufacturer Received

03/22/2022

Initial Date FDA Received

04/14/2022

Supplement Dates Manufacturer Received

05/19/2022
06/27/2022
07/01/2022

Supplement Dates FDA Received

06/02/2022
06/28/2022
07/13/2022

Was Device Evaluated by Manufacturer?

Is the Device Single Use?

Yes

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage

Initial

Patient Sequence Number

Patient Outcome(s)

Required Intervention; Other;

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

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