MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA ACCEL PLATELET + SAMPLER, PLASMA, RBC + AUTO PAS

Catalog Number 82420

Device Problems High Readings (2459); Improper Flow or Infusion (2954)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/06/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation: one used trima set was received for investigation.The vent bag and rbc bag were rf sealed, detached and returned with the set.The ac bag.Plasma bag, platelet bags and the pas bag were rf sealed and removed prior to return.The pas filter and clamp were not returned with the set.Blood was noted throughout the set.Clumping was observed in the inlet and ac lines, the inlet pump header, the return reservoir and in the cps.The clamps were all observed to be on the correct lines and assembled correctly.The white pinch clamps on the donor line and the sample bag line were noted to be in the closed position and the blue pinch clamp on the inlet line just before the 3to1 manifold was noted to be in the open position.The three mini pinch clamps on the channel lines were all observed to be in the closed positions.Fluid was flushed through the set via the ac line with the channel line clamps still closed and the lines were sufficiently occluded.Opening the channel line clamps allowed the flow of the fluid freely.The pressure sensors were intact and no damage observed.Further inspection noted no kinks, missing parts or disassemblies.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.Per the customer, before pas addition they received an alarm that the device could not verify that the clamps were closed.The staff used forceps on the three channel line clamps and continued the procedure.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.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 b.5, b.6, h.6 and h.10 and corrected information in a.1.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 lines are completely occluded.Based on the available information, an external clamp was placed on the three centrifuge lines before the alert screen was cleared.The channel line clamps closure test was completed successfully.Investigation is in process.A follow-up report will be provided.

Event Description

Per the customer, no qc testing of the unit was done for wbcs on the double product and the device did not flag for wbc verification.The customer indicated that the product was used, therefore, patient information and outcome are not available at this time.

Manufacturer Narrative

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.

Event Description

Due to eu personal data protection laws, the patient information is not available from the customer.Additionally, this unit was transfused, and no patient reaction was reported.

Manufacturer Narrative

This report is being filed to provide corrected information in e1.Investigation is in process.A follow up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.10.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 lines are completely occluded.Possible causes of this alarm are: - channel lines not clamped.- additive solution connected too early.- return pump occlusion error.- faulty return pump.- defective i/o two cca - defective pump driver cca - defective control cca.Based on the available information, an external clamp was placed on the three centrifuge lines before the alert screen was cleared.The channel line clamps closure test was completed successfully.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL PLATELET + SAMPLER, PLASMA, RBC + AUTO PAS
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 10081371
• MDR Text Key: 202604927
• Report Number: 1722028-2020-00244
• 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,Followup
• Report Date: 05/21/2020

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: 10/01/2021
• Device Catalogue Number: 82420
• Device Lot Number: 1910112230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2020
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 04/23/2020
• Initial Date FDA Received: 05/21/2020
• Supplement Dates Manufacturer Received: 06/05/2020; 11/18/2020; 05/07/2021; 06/30/2021
• Supplement Dates FDA Received: 06/16/2020; 11/19/2020; 05/12/2021; 07/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other