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

Model Number 82446

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Use of Device Problem (1670)

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

Event Date 12/05/2020

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.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.Donor unit #: w115120289554v the platelet collection set is not available for return because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provide additional information in b.6, h.6 and h.10.Investigation: 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.Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information in b.5, b.6, h.6 and h.10.Investigation: the customer provided donor tracking information including donor cbc results to aid in the investigation.The donor cbc confirmed the following: - the donor's wbc is 4.41e3/ul which is within the normal range of 10e3/ul.Root cause: based on the available evidence the cause of the leukoreductions failure was an operator error in which the collect line was closed for the first 40 minutes of the procedure.When the bag is clamped the platelet bed in the lrs chamber may not achieve the expected thickness and separation due to cellular back-up.Then when the clamp is opened the wbcs may escape with the platelets.Correction: retraining was provided to the customer on (b)(6) 2020.No further correction is recommended for this specific reported incident.

Event Description

The terumo bct clinical specialist determined that the collect bag line was clamped for the first 40 minutes of the procedure.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL LRS PLATELET, SAMPLER, PLASMA, RBC SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 11078379
• MDR Text Key: 224761796
• Report Number: 1722028-2020-00579
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583824461
• UDI-Public: 05020583824461
• Combination Product (y/n): N
• PMA/PMN Number: BK190332
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2022
• Device Model Number: 82446
• Device Catalogue Number: 82446
• Device Lot Number: 2008034251
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 06/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other