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

Catalog Number 000000000000080400

Device Problem Insufficient Information (3190)

Patient Problems Complaint, Ill-Defined (2331); Reaction (2414); Loss of consciousness (2418)

Event Date 12/19/2014

Event Type  Injury  

Event Description

The customer reported that a donor had a 'severe reaction' at the end of the double platelet donation procedure.The donation completed in 99 minutes, the donor needle was pulled,then the donor complained of feeling 'funny'.Per the customer's adverse reaction protocol, the donor was placed in trendelenburg position, applied cold towels, and the donor drank small sips of water.The donor then lost consciousness for approximately 60 seconds.The donor's vital signs had not returned to baseline after 20 minutes.Emergency medical services (ems) was called and the donor was transported to the emergency room (er) via ambulance.It is not known at this time if the donor required further treatment or follow-up visit.The donor is reported in stable condition.(b)(6).The disposable kit is not available for return because it was discarded by the customer.This report is being filed due to medical intervention via emergency services being called and transport via ambulance to the hospital.

Manufacturer Narrative

Investigation: the customer reported that the donor passed the medical history interview and physical exam and was intended to donate apheresis platelets.The donation was started without incident.The operator targeted a double platelet product (6.9 x 10^11) and a medium plasma volume (400 mls).Per the customer, during the donation there were no alarms noted or adjustments made to the procedure.The device history record (dhr) was reviewed for this lot.There were no issues noted in the dhr that would have contributed to the adverse reaction experienced by the donor.The run data file (rdf) was reviewed and there were no abnormal signals noted in the data.It was also confirmed that there were no alerts or adjustments made during the procedure.The trima machine operated as intended.Trima automated blood collection system operator¿s manual offers the following caution: ¿the trima accel system has many safety features.However, a donor reaction can occur rapidly.Therefore, it is imperative that the trima accel system and the donor be monitored throughout the procedure.¿ root cause: a definitive root cause for the donor¿s adverse reaction could not be determined.The customer is not alleging any deficiency of the trima machine or disposable set, the procedure¿s data file revealed the machine operated as intended and there were no contributing deviations from the manufacturing process of the disposable set.It is possible that the donor experienced a vasovagal response which can be caused by the donor¿s sensitivity to the various triggers.

Manufacturer Narrative

This record was identified during a retrospective review of mdr's to identify records in which an event occurred, but the type of reportable event was not indicated appropriately in the mdr form.This supplement is being filed to modify information to align with the reported event.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL PLATELET, PLASMA, RBC SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: glenda o'neill ; 10811 w. collins ave; lakewood, CO 80215 ; 3032314051
• MDR Report Key: 4413355
• MDR Text Key: 20748794
• Report Number: 1722028-2015-00013
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK140158
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/19/2014

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: 10/01/2016
• Device Catalogue Number: 000000000000080400
• Device Lot Number: 10W2124
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/19/2014
• Initial Date FDA Received: 01/13/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR
• Patient Weight: 102