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

Model Number	917000000
Medical Device Problem Codes	Human-Device Interface Problem (2949); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation: the device serial number history report indicates no further related issues have been reported for this device.The taps report confirmed that the gender for the procedure on (b)(6) 2018 was entered as male and the donor received 251 ml of ac.The customer confirmed they have changed the donor's gender to female in the vista system.One year of service history was reviewed for this device with no issues related to the reported condition identified.Root cause: the root cause was due to a data entry error by the operator.
Event or Problem Description
The customer reported that the operator inadvertently entered a female donor as a male for atrima platelet and plasma collection procedure.The ac infusion rate was >1.2 mls per minute per liter of tbv.The donor's actual tbv is 4262ml.For the procedure that was completed, the tbv was 4679 ml.The maximum ac infusion rate is 1.2 mls/min/liter of tbv.Based on the actual donor's tbv of 4262 ml, she should only have received 5.1 ml/min instead of 5.85 ml/min.Per the customer, the donor is in stable condition.
Additional Manufacturer Narrative
This report is being filed to provide corrected information and additional information.

• Brand Name: TRIMA ACCEL
• Common Device Name: TRIMA ACCEL AUTOMATED BLOOD COLLECTION SYSTEM
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 7898400
• Report Number: 1722028-2018-00261
• Device Sequence Number: 19181223
• Product Code: GKT
• UDI-Device Identifier: 05020583803602
• UDI-Public: 05020583803602
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: BK970005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2018

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
• Operator of Device: Health Professional
• Device Model Number: 917000000
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 08/30/2018
• Supplement Date Received by Manufacturer: 08/30/2018
• Initial Report FDA Received Date: 09/21/2018
• Supplement Report FDA Received Date: 09/21/2018
• 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
• Patient Age: 60 YR
• Patient Weight: 75