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

Catalog Number 4824062

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

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

Event Date 03/04/2024

Event Type  malfunction  

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.Donor unit id #: (b)(6) there was not a transfusion recipient or patient involved at the time of the residual wbc 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.

Manufacturer Narrative

Investigation: the run data file (rdf) was analyzed for this event."the signals in the run data file indicate that the higher-than-expected wbc content in the platelet product was possibly the result of a wbc saturation of the lrs chamber which occurred just before the start of the scheduled chamber clearing and which fell just under the detection threshold for flagging the platelet product for wbc verification.The signals in the run data file indicate that the device had difficulty maintaining steady state operation during the procedure, so it cannot be ruled out that the needle line access may have shifted and could potentially have impacted the collection.Additionally, based on the available information, it cannot be ruled out that the higher-than-expected wbc content in the platelet product may have been donor-related.Investigation is in process, a follow-up report will be provided.

Manufacturer Narrative

Investigation: the run data file (rdf) was analyzed for this event."the signals in the run data file indicate that the higher-than-expected wbc content in the platelet product was possibly the result of a wbc saturation of the lrs chamber which occurred just before the start of the scheduled chamber clearing and which fell just under the detection threshold for flagging the platelet product for wbc verification.The signals in the run data file indicate that the device had difficulty maintaining steady state operation during the procedure, so it cannot be ruled out that the needle line access may have shifted and could potentially have impacted the collection.Additionally, based on the available information, it cannot be ruled out that the higher-than-expected wbc content in the platelet product may have been donor-related.The device history records (dhr) were reviewed for this lot.There were no events noted in the dhr that would have contributed to the elevated wbc count experienced by the customer.Root cause: the signals in the run data file indicate that the higher-than-expected wbc content in the platelet product was possibly the result of a wbc saturation of the lrs chamber which occurred just before the start of the scheduled chamber clearing and which fell just under the detection threshold for flagging the platelet product for wbc verification.The signals in the run data file indicate that the device had difficulty maintaining steady state operation during the procedure, so it cannot be ruled out that the needle line access may have shifted and could potentially have impacted the collection.Additionally, based on the available information, it cannot be ruled out that the higher-than-expected wbc content in the platelet product may have been donor-related.

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.Donor unit id #: (b)(6).There was not a transfusion recipient or patient involved at the time of the residual wbc 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.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL PLATELET, PLASMA, RBC SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• 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: 19006833
• MDR Text Key: 339035298
• Report Number: 1722028-2024-00111
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583824065
• UDI-Public: 05020583824065
• 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
• Report Date: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 4824062
• Device Lot Number: 2308302142
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/09/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/30/2023
• 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