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

Model Number 80400

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

Patient Problems Syncope (1610); Hematoma (1884); Nausea (1970); Pain (1994); Tingling (2171); Electrolyte Imbalance (2196); Toxicity (2333); Injury (2348); Numbness (2415); Syncope/Fainting (4411)

Event Date 08/01/2017

Event Type  Injury  

Manufacturer Narrative

Lot number and expiry are not available at this time.Article citation: das, ss.Et.Al.2018.Machine and man individualities in apheresis adverse events.Global journal of transfusion medicine aatm.2018; volume 3: issue 1.Investigation is in process.A follow-up report will be provided.

Event Description

The article, 'machine and man individualities in apheresis adverse events' describes adverse events that occurred during platelet collection procedures with trima accel, cobe spectra, and amicus (not manufactured by terumo bct).The prospective study included 1455 plateletpheresis procedures from july 2013 to april 2016.Procedures were performed on amicus, trima accel and cobe spectra cell separators.The endpoint of each procedure was a yield of 3 × 1011 platelets (plts) per unit.The median age of donors was 31 years with male-to-female ratio of 13:1.The median body surface area and body mass index were 1.64 m2 and 22.4 kg/m2, respectively.The mean plt count of donors was 199.8 × 103/ul with a mean hemoglobin value of 13.6 g/dl.Acd infusion was significantly more in the cobe (p < 0.01).Donation time was least with the trima compared to amicus (p < 0.01) and cobe (p < 0.001).Total whole blood volume processed was higher in cobe (p < 0.01).Paresthesia due to citrate toxicity was the most common adverse reaction (65.3%), and vascular injury was observed in only five donors.The overall incidence of adverse reaction was 3.4%.For trima, median age and range was 36 (19-55), gender ratio, 18:1, weight 64.3±12.03 (kg), tbv m:4728±420, f:3507± 422 (ml).Adverse events for trima noted were citrate toxicity n=14; flushing, nausea n=1; syncope, vasovagal episodes with <60 heart rate n=1; vascular injury (hematoma or arm pain) with unknown medical intervention n=1.Specific details, such as patient information and any medical intervention necessary, were not provided in the article, therefore this report is being provided as a summary of the events.The disposable set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Root cause: a definitive root cause for the nausea, flushing, syncope and vasovagal reactions could not be determined.Possible causes include but are not limited to: donor's sensitivity to the procedure; donor's physiology a definitive root cause for the hematoma could not be determined.The authors stated that "however, majority of vascular injury can be prevented by good vein selection and skilled phlebotomist.Donor inattentiveness, excessive arm movement, or high return rate in a case of thin vein may cause vascular injury." a definitive 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, the citrate contents in the replacement fluid, and/or the length of the procedure.These symptoms may be treated with oral or intravenous calcium supplements or by adjusting the ac infusion rate.

Manufacturer Narrative

This report is being filed to provide additional information in b.5 and h.10.Investiagation: per the article, "none of the donors with citrate-related reactions needed intravenous therapy and were managed with oral elemental calcium in a dose of 1¿1.5g.The authors stated that most reactions were mild but did not specify if medical intervention was necessary for reports of flushing, syncope and vascular injury except one low-weight (54 kg) male donor who needed help from the emergency team for prolonged vasovagal symptoms and nausea." "in the present study, most reactions were mild, except one low-weight (54 kg) male donor who needed help from the emergency team for prolonged vasovagal symptoms and nausea." "we observed that factors such as low normal plt counts, average donor built, and average total blood volume necessitate high blood volume processing and high donor anticoagulant infusion to achieve the target yield of 3 × 1011 plts per unit.All these may contribute to donor adverse effects in plateletpheresis significantly.None of the 105 female donors had any adverse event despite being first-time donors and mean weight of 52 kg.This may be attributed to high plt count (mean: 266 × 103/ul) demonstrated in our female donors, which reduced the donation time (57.9 min vs.69.3 min, p < 0.001) and anticoagulant utilization (249 ml vs.291 ml, p < 0.01) significantly." 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.According to aabb technical manual 16th edition, 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.Dhr details: since this is prospective study that included 1455 plateletpheresis procedures performed on eligible donors from july 2013 to april 2016, 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.Investigation is in process.A follow up report will be provided.

Event Description

This is prospective study that included 1455 plateletpheresis procedures performed on eligible donors from july 2013 to april 2016.A request for specific patient information is not feasible.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL PLATELET, PLASMA, RBC SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: scot hilden ; 10810 w. collins ave; lakewood, CO 80215 ; 3032314970
• MDR Report Key: 10114504
• MDR Text Key: 196960256
• Report Number: 1722028-2020-00269
• 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,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2020
• 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
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 04/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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