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

Catalog Number 80355

Device Problems Misassembled (1398); Component Missing (2306)

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

Event Date 07/12/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation: the run data file (rdf) was analyzed for this event.Run data file analysis showed the tubing set test passed.Per system design, a missing rbc additive solution line will not be detected during the tubing set test.The ac line has an in-line sterile barrier filter without a frangible or clamp, which allows the ac pump to pull sterile air into the system during the tubing set test as necessary.The rbc additive solution line contains a frangible which prevents the ac pump from pulling air through it during the tubing set test when installed correctly.If the rbc additive solution line is not present, the ac pump will pull room air through the rbc additive solution empty bond socket in addition to the sterile air being pulled in from the ac line during the tubing set test.Since the ac pump can pull air as necessary during the tubing set test regardless of the presence of the rbc additive solution line, there will be no alert generated for a missing rbc additive solution line.During blood priming of the return line, the ac and return pumps run together to prime the return line and reservoir with anticoagulated donor blood.Since the ac pump was pulling in air with the ac through the open rbc additive solution line bond socket, air would have entered the return line during this priming process.During the first draw cycle, the air pulled in by the ac pump entered the inlet line, eventually building up to an air block in the inlet centrifuge line.This air block in the inlet centrifuge line triggered the ¿system pressure high¿ alerts due to an increase in pressure above the centrifuge pressure sensor limit.At a ¿system pressure high¿ alert, the centrifuge is commanded to stop.In this procedure, the centrifuge stop from the first ¿system pressure high¿ alert disrupted the channel priming process, which allowed rbcs to enter the platelet collection line and resulted in the ¿rbc detected¿ alert.Run data file analysis showed the first return cycle was not reached, and donor rinseback was not available when the procedure was terminated.As such, no air was returned to the donor.The customer provided four pictures in lieu of the disposable to aid in the investigation.The following observations were made based on the pictures: picture 1: this picture shows the front panel of the machine with the cassette loaded.The picture confirmed that the auto rbc line was missing.Picture a & c: both pictures confirm the presence of small air bubbles in the return line right below the cassette.Picture b: this picture confirms the presence of small air bubbles in the ac line, and in the inlet and return lines as well.The ac solution has leaked onto the machine and formed a puddle.Analysis of the images revealed a used trima cassette assembly containing blood loaded on a trima machine.The cassette is in the lowered position and blood has circulated throughout the set.The additive solution line is confirmed missing from the cassette bond socket and is confirmed as the source of the leak.Additionally, air bubbles are seen in the return line.A disposable complaint history search was performed for this lot and found no reports for similar issues on this lot worldwide.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Correction: terumo bct has implemented a correction for this incident.Manufacturing staff were made aware of this issue and retrained to the appropriate procedures.The retraining is documented in terumo bct¿s electronic training database under this quality record.Root cause: the cause of this defect was related to a mis-assembly, where the assembler neglected to attach or install completely a component to the set during manufacturing.This report was filed beyond the 30-day timeframe due to an internal processing error.An internal capa has been initiated to address the issue.

Event Description

The customer reported a leak from the anticoagulant (ac) line and an absence of the additive solution line on the disposables set during a platelet donation procedure.The procedure was stopped and a new disposables set was set up.The donation proceeded normally on the new set.Per the customer the donor was "ok".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.The disposables set is not available for return because it was discarded by the customer.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL LRS PLATELET, PLASMA, AUTO 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: 13543828
• MDR Text Key: 287672055
• Report Number: 1722028-2022-00047
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2022
• Device Catalogue Number: 80355
• Device Lot Number: 2010192130
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/12/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/16/2020
• 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: 32 YR
• Patient Sex: Male
• Patient Weight: 80 KG