MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA ACCEL AUTO RBC AND PLASMA SET

Catalog Number 80520

Device Problems Device Alarm System (1012); Use of Device Problem (1670); Inadequate User Interface (2958)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/13/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.The amount of citrate in as3 is 21.7mmol/l versus 113mmol/l for acda.The run data summary was analyzed for this event.Using data from the run summary, it was calculated by terumo bct that the total ac infusion rate was rate 0.80 ml/min/ltbv for this event.The replacement fluid line includes an iso 1135-4 compliant spike that is green in color to distinguish it from other fluid addition lines.When replacement fluid is enabled for a black stamp set which has a replacement line, the gui instructs the operator to connect saline to the replacement solution line and confirm the connected bag is saline.The trima accel operator's manual instructs the operator only to use normal (0.9%) saline as replacement solution, and not use saline containers larger than 1 liter.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that during an auto redo blood cell (rbc) plasma donation procedure on trima, the operator attached as-3 to the saline line in error.The device did not detect the error until the trima had transfused approximately 200 ml of as-3 during saline return.The operator was alerted to the issue when the trima had a level sensor error due to the as-3 bag being empty.Full donor identifier: (b)(6).The donor was released with no side effects following the donation.The customer followed up the following day to report the donor suffered no ill effects from the donation.The customer declined to provide the donor's age.The plasma rbc collection set is not available for return because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provide in correction: it was confirmed that the operator was retrained by the donor care manager on04/17/2019.Root cause: the root cause of the operator attaching as-3 to the saline line was a failure tofollow screen prompts to confirm the connected bag is saline.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL AUTO RBC AND PLASMA SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 8488020
• MDR Text Key: 146196313
• Report Number: 1722028-2019-00088
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583805200
• UDI-Public: 05020583805200
• Combination Product (y/n): N
• PMA/PMN Number: BK170157
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 04/05/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2020
• Device Catalogue Number: 80520
• Device Lot Number: 1807252230
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 03/13/2019
• Initial Date FDA Received: 04/05/2019
• Supplement Dates Manufacturer Received: 04/18/2019
• Supplement Dates FDA Received: 04/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AS-3 LOT NUMBER 18BC2010B, PRODUCT # 777966000
• Patient Outcome(s): Other
• Patient Weight: 101