MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA ACCEL LRS PLATELET, PLASMA SET

Model Number	82300
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Lot number and expiry are not available at this time.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.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 platelet collection set is not available for return because it was discarded by the customer.
Additional Manufacturer Narrative
This report is being filed to provide additional information in h.6 and h.10 investigation: the customer did not provide the lot number pertaining to this event, therefore a device history record (dhr) search could not be conducted for this specific incident.All lots must meet acceptance criteria before release.The run data file (rdf) was analyzed for this event.Root cause: analysis of the run data file confirms that the platelet products were flagged for possible wbc contamination, as the platelet concentration entering the lrs chamber was calculated to exceed the system limit.If the platelet concentration entering the lrs chamber gets too high, there is likely to be little separation between the platelets and the wbcs, increasing the likelihood for wbcs to exit the lrs chamber with the platelets and contaminate the platelet product.As such, when the concentration entering the lrs chamber was predicted to exceed the system limit, the system conservatively flagged the platelet product to be counted for wbcs.There is no suspicion of device or tubing set malfunction based on the run data file analysis.Analysis identified this to be correct system behavior.The occurrence rate of this flag depends on the configuration in combination with the actual donor pool.By changing the configuration (especially the collect concentration and/or the inlet flow management) the occurrence rate of this alert can be lowered.Upon examination of the run data file (rdf) for this event, one of the reasons for the wbc verification flag is "possible airblock" because at 21 minutes into the procedure, after receiving an alarm for low platelet concentration, the operator performed an air block recovery.This is the suggested troubleshooting step for this alarm.This results in no concern for air being returned to the donor.
Additional Manufacturer Narrative
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.The taps report for this run confirmed that the machine operated as intended and flagged the operator to verify the wbc count.Investigation is in process.A follow up report will be provided.

• Brand Name: TRIMA ACCEL
• Common Device Name: TRIMA ACCEL LRS PLATELET, PLASMA SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 10373171
• Report Number: 1722028-2020-00362
• Device Sequence Number: 2160294
• Product Code: GKT
• UDI-Device Identifier: 05020583823006
• UDI-Public: 05020583823006
• Combination Product (Y/N): N
• PMA/510(K) Number: BK190332
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/06/2020

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: 82300
• Device Catalogue Number: 82300
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2020
• Supplement Date Received by Manufacturer: 12/11/2020; 01/19/2021
• Initial Report FDA Received Date: 08/06/2020
• Supplement Report FDA Received Date: 12/18/2020; 01/29/2021
• 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