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

Model Number 82406

Device Problems No Apparent Adverse Event (3189); Insufficient Information (3190)

Patient Problem Hypervolemia (2664)

Event Date 03/03/2023

Event Type  malfunction  

Manufacturer Narrative

The run data file was analyzed for this event.The analysis of the run data file did not find a conclusive cause for the higher-than-expected product volume reported for the platelet product in this collection.While the level sensors do show a partial diversion of fluid, the volume deviation did not reach the threshold to trigger an alert on any single draw cycle.Specifically, the signals from the level sensors in the return reservoir indicate the possibility of diversion of fluid from the return reservoir to the platelet product bag, accounting for some of excess fluid collected.This discrepancy could be due to a tolerance stackup on the particular disposable used in this collection.It is also possible that this volume discrepancy could be due to a post collection weighing, calculation, or other process error.Investigation is in process, a follow-up report will be provided.

Event Description

The customer reported that the vista report listed the acd as 30, which is suspect due to the volume of the product.A product was collected and the staff noticed the volume did not match what was documented on the summary, indicated possible overdraw of the patient.The lab registered the product volume as 711.7ml and placed it on hold due to the discrepancy.Per the customer there was no issues reported for the patient for this event.Full unit id: (b)(6) per the customer, patient info was entered correctly and there were no issue reported for the patient status.

Event Description

The customer reported that the vista report listed the acd as 30, which is suspect due to the volume of the product.A product was collected and the staff noticed the volume did not match what was documented on the summary, indicated possible overdraw of the patient.The lab registered the product volume as 711.7ml and placed it on hold due to the discrepancy.Per the customer there was no issues reported for the patient for this event.Full unit id: (b)(6) per the customer, patient info was entered correctly and there were no issue reported for the patient status.

Manufacturer Narrative

Investigation: the run data file was analyzed for this event.The analysis of the run data file did not find a conclusive cause for the higher-than-expected product volume reported for the platelet product in this collection.While the level sensors do show a partial diversion of fluid, the volume deviation did not reach the threshold to trigger an alert on any single draw cycle.Specifically, the signals from the level sensors in the return reservoir indicate the possibility of diversion of fluid from the return reservoir to the platelet product bag, accounting for some of excess fluid collected.This discrepancy could be due to a tolerance stackup on the particular disposable used in this collection.It is also possible that this volume discrepancy could be due to a post collection weighing, calculation, or other process error.A disposable complaint history search was performed for this lot and found no reports for similar issues this lot worldwide.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.Fluid balance calculations, indicated the final fluid balance was not reportable.No further reporting will be provided as this does not represent a reportable event.Root cause: based on the information provided, the cause for the high collect volume in the platelet product could not be determined.The analysis of the run data file did not find a conclusive cause for the higher-than-expected product volume reported for the platelet product in this collection.While the level sensors do show a partial diversion of fluid, the volume deviation did not reach the threshold to trigger an alert on any single draw cycle.Specifically, the signals from the level sensors in the return reservoir indicate the possibility of diversion of fluid from the return reservoir to the platelet product bag, accounting for some but not all of the excess fluid reported.This discrepancy could be due to a tolerance stackup on the particular disposable used in this collection.It is also possible that this volume discrepancy could be due to a post-collection weighing, calculation, or other process error.

• 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: 16628369
• MDR Text Key: 312423840
• Report Number: 1722028-2023-00121
• Device Sequence Number: 1
• Product Code: GKT
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 82406
• Device Catalogue Number: 82406
• Device Lot Number: 2208263230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/27/2022
• 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
• Patient Age: 66 YR
• Patient Sex: Female