MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA ACCEL LRS PLATELET + 35 ML SAMPLER, PLASMA, AUTO RBC SET

Model Number 82616

Device Problems Contamination of Device Ingredient or Reagent (2901); Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/09/2021

Event Type  malfunction  

Manufacturer Narrative

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.The platelet collection set is not available for return because it was discarded by the customer.There was not a transfusion recipient or patient involved at the time of the unit processing, therefore no patient information is reasonably known at the time of the event.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.10.Investigation: the run data file (rdf) was analyzed for this event.Per the run data file, trima gave ¿verify the wbc content in platelet product¿ at the end of the procedure.The ¿verify wbc¿ was because of the ¿rbc spillover¿ that occurred approx.36 minutes into the procedure.When a spillover occurs, rbcs and wbcs are in the platelet line.When the procedure resumed those wbcs went to the platelet bag.Root cause: a root cause assessment was performed for this complaint.Based on the available information a definitive root cause could not be determined but it is likely due to one or a combination of the possible causes listed below: inaccurate hematocrit/hemoglobin entry.A procedure error.Donor blood variables.A disposables kit issue.A machine issue.A centrifuge stop.A tubing set loading error.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 machine operated as intended by flagging the product to verify wbcs.No further reporting will be provided as this does not represent a reportable event.

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.The platelet collection set is not available for return because it was discarded by the customer.There was not a transfusion recipient or patient involved at the time of the unit processing, therefore no patient information is reasonably known at the time of the event.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.10.Investigation: the run data file (rdf) was analyzed for this event.Per the run data file, trima gave ¿verify the wbc content in platelet product¿ at the end of the procedure.The ¿verify wbc¿ was because of the ¿rbc spillover¿ that occurred approx.36 minutes into the procedure.When a spillover occurs, rbcs and wbcs are in the platelet line.When the procedure resumed those wbcs went to the platelet bag.Root cause: a root cause assessment was performed for this complaint.Based on the available information a definitive root cause could not be determined but it is likely due to one or a combination of the possible causes listed below: inaccurate hematocrit/hemoglobin entry.A procedure error.Donor blood variables.A disposables kit issue.A machine issue.A centrifuge stop.A tubing set loading error.

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.The platelet collection set is not available for return because it was discarded by the customer.There was not a transfusion recipient or patient involved at the time of the unit processing, therefore no patient information is reasonably known at the time of the event.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL LRS PLATELET + 35 ML SAMPLER, PLASMA, AUTO RBC SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80214
• Manufacturer (Section G): TERUMO BCT; 10810 w. collins ave; lakewood CO 80215
• Manufacturer Contact: scot hilden ; 10810 w. collins ave; lakewood, CO 80215
• MDR Report Key: 13152738
• MDR Text Key: 286260629
• Report Number: 1722028-2022-00003
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583826168
• UDI-Public: 05020583826168
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK190332
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date: 01/04/2022

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: 10/01/2023
• Device Model Number: 82616
• Device Catalogue Number: 3826162
• Device Lot Number: 2110282132
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/10/2021
• Initial Date FDA Received: 01/04/2022
• Supplement Dates Manufacturer Received: 04/26/2022; 05/11/2022
• Supplement Dates FDA Received: 05/07/2022; 05/31/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/29/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other