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

Catalog Number 80537

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

Patient Problems Fatigue (1849); Low Blood Pressure/ Hypotension (1914); Pallor (2468)

Event Date 04/30/2022

Event Type  Injury  

Event Description

The customer reported that during the blood collection around the time the plasma is separated to 647 ml, the donor felt sleepy with sense of defecation.The blood pressure and pulse were dropped with cold sweat and facial pallor.The doctor treated the donor with infusion of lactate ringer solution 250ml with calcicol 1 unit, the donor was recovered in 15 minutes.The donor had a high hematocrit level of 49.4% before the blood draw.This donor is a repeat donor and has not experienced the same event in the past.Due to data protection laws, the patient (donor) information is not available from the customer.The set is not available for return for evaluation.This product is not available within the us, but this report is being filed due to an alleged failure that could occur on a similarly marketed device platform cleared for use by the fda.

Manufacturer Narrative

Investigation: dhr could not be assessed as the customer was unable to provide the lot number.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, 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.There is no evidence to suggest a malfunction of the disposable set or the trima device caused or contributed to the reported adverse reactions.Root cause: a specific root cause for the reported reaction could not be determined.The reported adverse reactions 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.

• Brand Name: TRIMA ACCEL
• Type of Device: ACCEL PLASMA SET,JAPANESE
• 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: 14622724
• MDR Text Key: 293488922
• Report Number: 1722028-2022-00184
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/07/2022

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 80537
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/13/2022
• Initial Date FDA 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; Required Intervention