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

Catalog Number 80300

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Vaso-Vagal Response (2661)

Event Date 04/28/2016

Event Type  Injury  

Manufacturer Narrative

Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that during a research procedure, a patient (donor) experienced a vasovagal reaction.It is unknown at this time if medical intervention was required for this event.Patient (donor) information is not available at this time.The disposable kit is not available for return because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provide additional information in evaluation codes and additional mfr narrative.Investigation: the customer did not provide the lot number pertaining to this event,therefore a device history record (dhr) search could not be conducted for this specific incident.All lots must meet acceptance criteria before release.Further evaluation of this event has determined that the device did not cause or contribute to a death or serious injury, nor is there a likely potential for death or serious injury associated with this event based on additional investigational information.During customer follow-up, customer stated that the patient (donor) was given first aid for the vasovagal reaction.Therefore, medical intervention beyond first aid was not required for this event.Per the therapeutic apheresis handbook: a physician's reference, 2nd edition, first time procedure patients reactions may occur in approximately 4.8% of procedures, based on the results of a survey of therapeutic procedures.Of these reactions, most were mild and well tolerated.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: due to insufficient data about the outcome of the procedure, a definitive root cause could not be determined.Possible causes include but are not limited to:- donor/patient physiology- donor/patient's apprehension about apheresis procedure (nervousness)- machine settings, ac infusion rate too fast for the donor/patient.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL PLATELET, PLASMA SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: matthew bickford ; 10810 w. collins ave; lakewood, CO 80215 ; 3032052494
• MDR Report Key: 5841343
• MDR Text Key: 50999434
• Report Number: 1722028-2016-00436
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK150321
• 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: 08/02/2016

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 Catalogue Number: 80300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/08/2016
• Initial Date FDA Received: 08/02/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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