MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA MACHINE FINAL ASSY

Model Number 81000

Device Problems Computer Software Problem (1112); High Test Results (2457)

Patient Problem No Patient Involvement (2645)

Event Date 05/09/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation: one year of service history was reviewed for this device with no issues related to the reported condition identified.The device serial number history report indicates no further related issues have been reported for this device.The run data file (rdf) was analyzed for this event.Run data file analysis showed the operator made 19 ¿draw flow¿ up adjustments and 1 ¿draw flow¿ down adjustment between 49 and 55 minutes into this procedure.About 9 of the ¿draw flow¿ up adjustments were made during are turn cycle.Analysis determined that the inlet flow increased by more than expected during the return cycle from these manual adjustments.Analysis identified this issue to be a software anomaly.As such, the issue has been elevated to the software team.The inlet pump speed is intended to always be a fraction of the return pump speed.However, in this procedure, the ¿draw flow¿ up adjustments caused the inlet pump speed to exceed the return pump speed during the return cycle.The return pump speed could not increase accordingly because it was capped at a specific flow rate due to the system substate transition.The ac, plasma, and collect pump speeds increased accordingly with the inadvertent inlet pump speed increase.Therefore, rbcs exited from the top of the collect connector into the plasma line because the plasma pump flow increased by more than intended.Investigation is in process.A follow up report will be provided.

Event 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.There was not a transfusion recipient or patient involved at the time of the residual white blood cell (rwbc) testing, therefore no patient information is reasonably known at the time of the event.The wbc count is not available, at this time.

Manufacturer Narrative

This report is being filed to provide corrected information in e.1 and e.3.Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

Root cause: run data file analysis showed the operator made 19 ¿draw flow¿ up adjustmentsand 1 ¿draw flow¿ down adjustment between 49 and 55 minutes into this procedure.About 9 ofthe ¿draw flow¿ up adjustments were made during a return cycle.Analysis determined that theinlet flow increased by more than expected during the return cycle from these manualadjustments.Analysis identified this issue to be a software anomaly.As such, the issue has beenelevated to the software team.The inlet pump speed is intended to always be a fraction of the return pump speed.However, inthis procedure, the ¿draw flow¿ up adjustments caused the inlet pump speed to exceed thereturn pump speed during the return cycle.The return pump speed could not increaseaccordingly because it was capped at a specific flow rate due to the system substate transition.The ac, plasma, and collect pump speeds increased accordingly with the inadvertent inlet pumpspeed increase.Therefore, rbcs exited from the top of the collect connector into the plasma linebecause the plasma pump flow increased by more than intended.

Event Description

The wbc was not provided by the customer.Due to japanese personal data protection laws, the patient information/unit information is notavailable from the customer.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA MACHINE FINAL ASSY
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 8678898
• MDR Text Key: 147754626
• Report Number: 1722028-2019-00134
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583810006
• UDI-Public: 05020583810006
• Combination Product (y/n): N
• PMA/PMN Number: BK110009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/07/2019

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 Model Number: 81000
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 05/13/2019
• Initial Date FDA Received: 06/07/2019
• Supplement Dates Manufacturer Received: 07/02/2019; 08/12/2019
• Supplement Dates FDA Received: 07/02/2019; 08/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other