MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA ACCEL MULTIPLASMA

Model Number 82700

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Thrombosis (2100)

Event Date 08/04/2020

Event Type  Injury  

Manufacturer Narrative

Investigation: the customer is not alleging a problem with the device.The customer reported she does not believe the donation is related to the incident.The procedure summary was reviewed for this event.There were no alerts or adjustments, this was a very clean plasma collection with no reason to suspect clots or any problem with the procedure.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that one week after a plasma donation using a trima device, the donor returned to the donation site and reported his arm was sensitive to touch.Per the customer there were no visible signs of bruising at that time.Per the customer, the sensitivity continued so the donor went to urgent care followed by a trip to the emergency room.An ultrasound determined the donor had clotting in his arm.He was placed on blood thinners.The donor reported years earlier he had clotting in his leg as a result of trauma to the leg.Per the customer the blood center staff did not order or suggest medical intervention.Per the customer, at this time the donor is recovering with no additional medical treatment other then follow up with his md.Per the customer, there were no problems with the procedure, no access or return alarms.Full patient (donor) id: (b)(6).Patient age is not available at this time.The disposable set is not available for return because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provide additional information in b.5, h.6 and h.10.Investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Per the rdf, the system operated as intended and the procedure was run within standard operating limits.The disposable lot query was performed for lot 2006172130 and no similar reported occurrences were received against this lot to date.According to aabb technical manual 16th edition, adverse events 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 3400 donors.Only one case of thrombosis has been reported in the literature.Symptoms include pain; antecubital fossa tenderness; swelling of the arm; and a prominent, palpable, cord-like thickening of the thrombosed vein.Medical referral of donors who are experiencing deep vein thrombosis should not be delayed, so that treatment with anticoagulant can begin promptly root cause: a definitive root cause could not be determined.Possible causes include but are not limited to: congenital condition that increases risk of blood clots e.G.Factor v leiden or protein c or protein s.Prolonged inactivity that decreases blood flow.Poor phlebotomy technique.Difficult access for fragile vessels.Rapid return flows.

Event Description

The customer did not respond to attempts to obtain the patient (donor) age.Per the customer it was a superficial clot and no anticoagulants were needed.The donor has been back to donate plasma many times since with no issues.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL MULTIPLASMA
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 10515421
• MDR Text Key: 206490797
• Report Number: 1722028-2020-00437
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583827004
• UDI-Public: 05020583827004
• Combination Product (y/n): N
• PMA/PMN Number: BK190332
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 09/10/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2022
• Device Model Number: 82700
• Device Catalogue Number: 82700
• Device Lot Number: 2006172130
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 08/19/2020
• Initial Date FDA Received: 09/10/2020
• Supplement Dates Manufacturer Received: 03/08/2021
• Supplement Dates FDA Received: 03/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Weight: 100