MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA ACCEL ENHANCED PLT, PLASMA, RBC, AUTORBC SET

Catalog Number 80360

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

Patient Problems Bruise/Contusion (1754); Thrombus (2101)

Event Date 02/03/2016

Event Type  Injury  

Manufacturer Narrative

Investigation: per the customer, "possible bruising" was documented on the run sheet, but no post-donation care was documented at that time.The run data file was analyzed for this event.The run data file showed the trima system operated as intended and there were no issues with the way the trima functioned during the run.The customer has continued to use the trima for a month since the event without a reoccurrence of the issue.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that the day following a donation, the donor had called and reported bruising.The medical director at the customer site recommended that the donor seek follow-up due to the extent of the bruising.The donor visited her doctor and was placed on anticoagulant therapy due to blood clots found in her neck and brachial artery.Per the customer, the donor did not have prior clinical history of clotting disorders.The customer declined to provide the patient's weight.The disposable kit is not available for return, because it was discarded by the customer.

Manufacturer Narrative

Investigation: a review of the device history record for this unit showed no irregularities during manufacturing that were relevant to this issue.During donor follow-up with the customer, the customer indicated that the donor was treated for blood clots with anticoagulant therapy and no donor injury was reported.Hematoma is one of several known side effects associated with apheresis procedures.Also, an inadequate needle stick can produce inadequate anticoagulation which may result in thrombo-emboli to the donor.Per the american association of blood banks (aabb) technical manual, hematoma and other side effects include nerve irritation, local allergy, arterial puncture, vasovagal reactions, (among other possible reactions) are also frequent in whole blood donation and are recognized risks of collecting blood products for transfusion.A service call was placed and a semi-annual preventive maintenance (pm) was performed.The machine is functioning per manufacturer's specification.Root cause: the root cause for the bruising that the donor experienced cannot be determined from the information provided.Possible causes include but are not limited to: poor needle entry such that the needle protrudes through the distal side of the vein.Abrasion at the needle entry site.Abrasion of the vein wall.Higher flow rate than the vein can accommodate.Information from the customer did not indicate any knowledge of a clotting disorder for this donor.The clotting was likely, though not conclusively, related to the hematoma.

Event Description

The customer declined to provide the patient's age.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL ENHANCED PLT, PLASMA, RBC, AUTORBC SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: matthew bickford ; 10810 w collins ave; lakewood, CO 80215 ; 3032052494
• MDR Report Key: 5532267
• MDR Text Key: 41368825
• Report Number: 1722028-2016-00151
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK150269
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/29/2016

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: 01/01/2018
• Device Catalogue Number: 80360
• Device Lot Number: 01Z3204
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/04/2016
• Initial Date FDA Received: 03/29/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2016
• 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): Required Intervention
• Patient Weight: 82