MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA ACCEL RBC PLT/PLASMA

Model Number 80400

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

Patient Problems Bruise/Contusion (1754); Fatigue (1849); Hematoma (1884); Hypersensitivity/Allergic reaction (1907); Cramp(s) /Muscle Spasm(s) (4521)

Event Date 09/01/2019

Event Type  Injury  

Manufacturer Narrative

Lot number and expiry are not available at this time.Investigation: the article describes adverse donor events as, "immediate adverse donor events (iades) occur before, during, or after the donation while the donor is in the blood donation premises, while delayed adverse donor events (d-ades) may occur at any time after the donor leaves the donation premises, usually up to 2 to 3 weeks after donation." citation: gupta am, bajpai m.The impact of delayed and immediate adverse events on the intention of future donations in whole blood and plateletpheresis donors.J clin apher.2021;36:621¿627.Https://doi.Org/10.1002/ jca.21902 investigation is in process.A follow up report will be provided.

Event Description

The article, 'the impact of delayed and immediate adverse events on the intention of future donations in whole blood and plateletpheresis donors', discusses a prospective observational study that was done at a tertiary care hospital-based blood transfusion service.The study was conducted over 11 months from october 2018 to august 2019.All plateletpheresis procedures were done on either haemonetics mcs+ ((b)(6)) or trima accel (terumo bct, (b)(4)).A total of 531 plateletpheresis donors were included in the study.The median age, weight, hemoglobin, and platelet counts of the plateletpheresis donors were 29 years, 75 kg, 15.3 mg/dl, and 233/l respectively.The following table summarizes the number of adverse events for plateletpheresis donors.This list includes use of both the haemonetics mcs+ or trima accel, the data was not segregated by the authors.Adverse event number (percent) bruise 39 (7.3) sore arm 19 (3.6) hematoma 10 (1.9) allergic reaction 11 (2.1) delayed bleeding 12 (2.3) parasthesiae 6 (1.1) fatigue/weakness 12 (2.3) vaso-vagal reaction 3 (0.6) muscular spasm 2 (0.4) the article did not provide further details about the adverse donor events, including whether or not medical intervention was necessary for any.Exact patient details were not included in the article, therefore this report is being filed as a summary of events.The devices are not available for return for evaluation.

Event Description

The article, 'the impact of delayed and immediate adverse events on the intention of future donations in whole blood and plateletpheresis donors', discusses a prospective observational study that was done at a tertiary care hospital-based blood transfusion service.The study was conducted over 11 months from october 2018 to august 2019.All plateletpheresis procedures were done on either haemonetics mcs+ (braintree, massachusetts) or trima accel (terumo bct, lakewood, colorado).A total of 531 plateletpheresis donors were included in the study.The median age, weight, hemoglobin, and platelet counts of the plateletpheresis donors were 29 years, 75 kg, 15.3 mg/dl, and 233/¿l respectively.The following table summarizes the number of adverse events for plateletpheresis donors.This list includes use of both the haemonetics mcs+ or trima accel, the data was not segregated by the authors.Adverse event number (percent) bruise 39 (7.3) sore arm 19 (3.6) hematoma 10 (1.9) allergic reaction 11 (2.1) delayed bleeding 12 (2.3) parasthesiae 6 (1.1) fatigue/weakness 12 (2.3) vaso-vagal reaction 3 (0.6) muscular spasm 2 (0.4) the article did not provide further details about the adverse donor events, including whether or not medical intervention was necessary for any.Exact patient details were not included in the article, therefore this report is being filed as a summary of events.The devices are not available for return for evaluation.

Manufacturer Narrative

Investigation: the article describes adverse donor events as, "immediate adverse donor events (iades) occur before, during, or after the donation while the donor is in the blood donation premises, while delayed adverse donor events (d-ades) may occur at any time after the donor leaves the donation premises, usually up to 2 to 3 weeks after donation." since this is a study which evaluated the impact of delayed adverse events (d-ades) and immediate ades (i-ades) on the intention of future donations (ifds) of whole blood and plateletpheresis donors using both haemonetics mcs+ and trima over 11 months from october 2018 to august 2019, the lot numbers were not provided; therefore, a disposable lot history search could not be conducted.Citation: gupta am, bajpai m.The impact of delayed and immediate adverse events on the intention of future donations in whole blood and plateletpheresis donors.J clin apher.2021;36:621¿627.Https://doi.Org/10.1002/ jca.21902 investigation is in process.A follow up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.10.Investigation: the article describes adverse donor events as, "immediate adverse donor events (iades) occur before, during, or after the donation while the donor is in the blood donation premises, while delayed adverse donor events (d-ades) may occur at any time after the donor leaves the donation premises, usually up to 2 to 3 weeks after donation." since this is a study which evaluated the impact of delayed adverse events (d-ades) and immediate ades (i-ades) on the intention of future donations (ifds) of whole blood and plateletpheresis donors using both haemonetics mcs+ and trima over 11 months from (b)(6) 2018 to (b)(6) 2019, the lot numbers were not provided; therefore, a disposable lot history search could not be conducted.Citation: gupta am, bajpai m.The impact of delayed and immediate adverse events on the intention of future donations in whole blood and plateletpheresis donors.J clin apher.2021;36:621¿627.Https://doi.Org/10.1002/ jca.21902.Since this is a study which evaluated the impact of delayed adverse events (d-ades) and immediate ades (i-ades) on the intention of future donations (ifds) of whole blood and plateletpheresis donors using both haemonetics mcs+ and trima over 11 months from (b)(6) 2018 to (b)(6) 2019, the disposable sets were not available for return.Since this is a study which evaluated the impact of delayed adverse events (d-ades) and immediate ades (i-ades) on the intention of future donations (ifds) of whole blood and plateletpheresis donors using both haemonetics mcs+ and trima over 11 months from (b)(6) 2018 to (b)(6) 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.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 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.

Event Description

The article, 'the impact of delayed and immediate adverse events on the intention of future donations in whole blood and plateletpheresis donors', discusses a prospective observational study that was done at a (b)(6) hospital-based blood transfusion service.The study was conducted over 11 months from (b)(6) 2018 to (b)(6) 2019.All plateletpheresis procedures were done on either haemonetics mcs+ (braintree, massachusetts) or trima accel ((b)(6), colorado).A total of (b)(4) plateletpheresis donors were included in the study.The median age, weight, hemoglobin, and platelet counts of the plateletpheresis donors were 29 years, 75 kg, 15.3 mg/dl, and 233/l respectively.The following table summarizes the number of adverse events for plateletpheresis donors.This list includes use of both the haemonetics mcs+ or trima accel, the data was not segregated by the authors.Adverse event number (percent) bruise 39 (7.3) sore arm 19 (3.6) hematoma 10 (1.9) allergic reaction 11 (2.1) delayed bleeding 12 (2.3) parasthesiae 6 (1.1) fatigue/weakness 12 (2.3) vaso-vagal reaction 3 (0.6) muscular spasm 2 (0.4) the article did not provide further details about the adverse donor events, including whether or not medical intervention was necessary for any.Exact patient details were not included in the article, therefore this report is being filed as a summary of events.The devices are not available for return for evaluation.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL RBC PLT/PLASMA
• 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: 14174227
• MDR Text Key: 294640523
• Report Number: 1722028-2022-00131
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583804005
• UDI-Public: 05020583804005
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: BK190332
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 80400
• Device Catalogue Number: 80400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/07/2022
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other