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

Model Number	80400
Health Effect - Clinical Code	Reaction (2414)
Date of Event	07/16/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lot number and expiry information are not available at this time.Article citation: gupta am, bajpai m.Delayed adverse events in male plateletpheresis donors: initial insights on donor safety.J clin apher.2020;35:18¿24.Https://doi.Org/10.1002/jca.21753 investigation is in process.A follow-up report will be provided.
Event or Problem Description
The article, 'delayed adverse events in male plateletpheresis donors: initial insights on donor safety' (gupta 2019) describes a study of 531 male platelet donors to assess immediate and delayed adverse events.Trima accel was used for over half (n= 276) of the platelet collections.In this prospective observational study all eligible donors were contacted by telephone twice and asked about general wellbeing and questions specific to adverse donor events (ades).Donors were called at 24 hours and 2 weeks after donation.The ades were categorized in accordance with the international society of blood transfusion standard guidelines.All study participants were males.The median age, weight, and hemoglobin of the donors were 29 years, 75 kg and 15.3 mg/dl, respectively.Immediate adverse events (i-ade) reported included hematomas (n = 19), muscular spasms (n = 6) and vaso- vagal reactions (vvrs) (n = 4).Mild citrate toxicity in the form of circumoral/digital paresthesiae and a feeling of vibrations was the most common i-ade seen in 274 (51.6%).34.06% (n=93) of the parasthesiae incidents occurred on trima.Delayed adverse events included bruising (n = 39), sore arms (n = 19), fatigue or non-specific weakness (n = 12), delayed bleeding from the site of phlebotomy (n = 12), allergic events or itching at the phlebotomy site (n = 11), delayed hematoma formation (n = 10), delayed paresthesiae (n = 6), delayed vvrs (n = 3) and delayed muscular spasms (n = 2).The platform used for the donations was not specified for the adverse events (except for the parasthesia incidents).Specific details, such as patient (donor) information and any medical intervention required, were not included 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.
Additional Manufacturer Narrative
This report is being filed to provide additional information in b5, e.1, h6 and h10 invstigation: the authors did not specify if any medical intervention was required to mitigate any of the adverse reactions.All the i-ades were grade i and all the d-ades were grade ii as per the grading severity of blood donor adverse events tool by aabb donor haemovigilance working group.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.Dhr details: since this was an observational study on 531 donors between october 2018 to june 2019 to primarily analyse the frequency and type of delayed adverse donor events, 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.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 donor physiology, 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 authors stated that "donors whose procedures lasted for more than 60 minutes and required more than 300 ml of anticoagulant were associated with a higher incidence of paresthesiae.Delayed paresthesiae were reported in donation procedures longer than =61 minutes.It was more common in donors with platelet counts =230 × 103/¿l, using more than =301 ml acd and in donors with body weight =75 kg.No significant correlation was found between sore arms and donor or procedure parameters.Fatigue or non-specific weakness was more common in donors weighing =75 kg and first-time donors.It was also common in donation procedures longer than 60 minutes.Few donors had undertaken strenuous physical activity including sports or smoked immediately after the donation which lead to post-donation weakness.Three donors told that they removed the adhesive band immediately after leaving the bts, this lead to slight bleeding.Two donors gave a history of baggage lifting before bleeding.10 bruising was also common as hematomas later on present as bruises and sometimes minute amounts of blood may seep into the subcutaneous tissue which may not be sufficient to cause a hematoma but sufficient to present as bruising.Delayed hematoma formation was reported by 10 donors.Four donors said that they lifted a heavy bag or did a strenuous exercise before hematoma formation.Sports activities, strenuous physical activity, lifting of bags/ luggage or re-trauma to the phlebotomy site may be few of the reasons for delayed hematomas.Allergic events or itching at the phlebotomy site was reported by 11 donors.Four donors were first-time donors while seven were repeat donors.Sensitivity to medicated adhesive bands or antiseptics used for disinfection or metal alloy of the needle may be the causes for the delayed allergic reaction in blood donors." a definitive root cause for the vasovagal reaction, muscular spasms/leg cramps, fever and diarrhea could not be determined.Possible causes for the alleged vasovagal reaction include but are not limited to donor physiology, length of the procedure and/or donor sensitivity to the procedure.
Event or Problem Description
In addition to the other reported adverse events, the article also mentions three donors reported having a fever after ap procedure.The fever episodes were reported between day one and day nine of donation.In all the cases the fever receded without any diagnosis and complications.Diarrhea was reported by a single donor on day four of donation.None of the donors required hospitalization.This was an observational study on 531 donors between october 2018 to june 2019 to primarily analyse the frequency and type of delayed adverse donor events.A request for specific patient information is not feasible.

• Brand Name: TRIMA ACCEL
• Common Device Name: 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: 10106822
• Report Number: 1722028-2020-00263
• Device Sequence Number: 2561623
• Product Code: GKT
• UDI-Device Identifier: 05020583804005
• UDI-Public: 05020583804005
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: BK190332
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2020

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?: No
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2020
• Supplement Date Received by Manufacturer: 05/06/2022
• Initial Report FDA Received Date: 06/01/2020
• Supplement Report FDA Received Date: 05/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown