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

Catalog Number 82420

Device Problems Component Missing (2306); No Apparent Adverse Event (3189)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/27/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation: one used trima set was received for investigation.Initial observations noted that blood is present throughout the set.The ac bag, drip chamber and filter, the plasma bag, the platelet bags and the pas bag and filter have all been rf sealed and removed prior to return.Visual inspection noted that only two mini pinch clamps were present on the channel lines, flossed correctly and in the closed position: one on the rbc line from centrifuge and one on the plasma line from the centrifuge.The mini pinch clamp was missing from the platelet line from the centrifuge.No further missing parts were noted.No kinks or misassemblies were observed.Clumping was noted in the channel, the draw/return pressure sensor, in the inlet line around the cps and in the return pump header.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that upon donor closure for a trima donation procedure, they noted that three white clamps were missing.No blood product was lost.It is unknown at this time if there is a patient involved.Wbc count is not available at this time.This product is not available within the us, but this report is being filed due to an alleged failure that could occur on a similarly marketed device platform cleared for use by the fda.

Manufacturer Narrative

This report is being filed to provide additional information in b6, h4, h6 and h10.Investigation: the run data file (rdf) was analyzed for this event.During the pas addition phase, the device checks the correct closing of the channel line clamps.A ¿channel line clamp error¿ is generated when the device cannot verify that the channel line clamps are closed.Based on the available information, an external clamp was placed on the platelet centrifuge line before the alert screen was cleared.The channel line clamps closure test was completed successfully.The cassette cleaning and pas addition where performed as expected.Investigation is in process.A follow up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information in b.6 and h.10.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.It was determined that the wbc count was below 5.0x10^6 and the machine flagged to verify wbcs in platelet product due to hematocrit too high and platelet contamination detected.Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

Investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Correction: information regarding failures of this type is regularly shared with the relevant manufacturing teams.Root cause: during the pas addition phase, the device checks the correct closing of the channel line clamps.A ¿channel line clamp error¿ is generated when the device cannot verify that the channel line clamps are closed.Based on the available information, an external clamp was placed on the platelet centrifuge line before the alert screen was cleared.The channel line clamps closure test was completed successfully.The cassette cleaning and pas addition where performed as expected.For the flagged, potential wbc failure: the trima accel system has software algorithms that use signals from the rbc detector to determine if wbcs may be escaping the lrs chamber, potentially contaminating the platelet product.The notification to count the platelet product for wbcs was generated because during this procedure these algorithms acted appropriately and detected that wbcs were escaping the lrs chamber.Run data file analysis did not show a conclusive root cause for this flagged leukoreduction failure.Experience has shown that this type of failure may be donor related.For the missing clamp: the cause of this defect was related to a mis-assembly, where the assembler neglected to attach or install completely a clamp to the set during manufacturing.

Event Description

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.Donor unit #: (b)(4).

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL LRS PLATELET, SAMPLER,AUTOPAS, PLASMA,RBC
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 10101171
• MDR Text Key: 209579610
• Report Number: 1722028-2020-00258
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2022
• Device Catalogue Number: 82420
• Device Lot Number: 2001302330
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2020
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 11/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other