MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA ACCEL AUTOMATED BLOOD COLLECTION SYSTEM

Model Number 81000

Device Problem Device Displays Incorrect Message (2591)

Patient Problem Hypovolemia (2243)

Event Date 01/05/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The customer reported receiving a "donor hypovolemia" alarm.No further information regarding circumstances involved with the alarm are available at this time.Due to eu personal privacy protection laws, patient information is not available from the customer.

Manufacturer Narrative

Investigation: terumo bct's service technician was unable to confirm the reported condition during machine checkout.A one year review of the device's service history was performed with no issues noted related to the reported condition.An internal report shows that the machine has been in use with no further occurrences of the problem.The device alarmed as designed with a fail safe condition which ends the donation.Root cause: the root cause of the alarm reported by the customer was undetermined.Potential causes of the alarm include the plasma or platelet pumps running too fast, disconnect test failed resulting in the device thinking the collected volume is too high and a defective safety computer.The service technician was unable to confirm the reported condition.

Manufacturer Narrative

This record was identified during a retrospective review of mdrs 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 AUTOMATED BLOOD COLLECTION SYSTEM
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: matthew bickford ; 10810 w collins ave; lakewood, CO 80215 ; 3032052494
• MDR Report Key: 5399915
• MDR Text Key: 37243883
• Report Number: 1722028-2016-00038
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: BK150269
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/29/2016

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 Model Number: 81000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/05/2016
• Initial Date FDA Received: 01/29/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/23/2016; 08/24/2016
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other