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

Model Number	81002
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation: a (b)(4) bct service technician checked out the machine at the customer site.Nothing was found during diagnostic testing.The white blood cell (wbc) detector was checked, calibrated again and the machine was found in working order.Investigation is in process.A follow-up report will be provided.
Event or Problem Description
The customer would like the run data file investigated to determine a possible cause for the elevated white blood cell (wbc) content in the platelet product.The wbc count is not available at this time.There was not a transfusion recipient or patient involved at the time of this incident.Therefore, no patient information is reasonably known at the time of the event.
Additional Manufacturer Narrative
This report is being filed to provide additional information and corrected information.Investigation: 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.It was confirmed that the trima device flagged to verify the product due to red blood cell (rbc) spillover and therefore produced a fail safe alarm.The service representative was unable to confirm the reported condition.While testing indicated the device was operating per manufacturer specifications; the rbc detector was proactively recalibrated.The device serial number history report indicates no further related issues have been reported for this device.One year of service history was reviewed for this device with no issues related to the reported condition identified.Root cause: the root cause of this failure was undetermined.Possible causes of the alarm for potential wbc contamination include, but are not limited to, an rbc spillover or mis-calibrated rbc detector.

• Brand Name: TRIMA ACCEL
• Common Device Name: TRIMA ACCEL AUTOMATED BLOOD COLLECTION SYSTEM
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 8117845
• Report Number: 1722028-2018-00314
• Device Sequence Number: 13880688
• Product Code: GKT
• UDI-Device Identifier: 05020583810020
• UDI-Public: 05020583810020
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: DO
• PMA/510(K) Number: BK150321
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 81002
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2018
• Supplement Date Received by Manufacturer: 12/13/2018
• Initial Report FDA Received Date: 11/29/2018
• Supplement Report FDA Received Date: 12/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other