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

Catalog Number 82321

Device Problems Backflow (1064); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Air Embolism (1697); No Known Impact Or Consequence To Patient (2692)

Event Date 12/14/2018

Event Type  malfunction  

Manufacturer Narrative

Investigation: the customer reported that the donor center carried out a dummy run with a cda as part of their internal investigation.The observed small air bubbles present in the return line tubing during the first couple of return cycles.No fault was found.Terumo bct conducted a test run on another 82321 disposables set and some air bubbles were observed in the return line, however, it is believed that they are an artifact of using the less viscous fluid of saline compared to blood.Per trima¿s design, after the donor has been connected,the inlet pump primes the inlet line.Then, the return pump runs backward and primes the return line into the reservoir.That is how the trima ensures that no air is returned to the donor and how it prevents it.As it is pulling the blood directly from the donor, there should not be any air entering the line, and therefore residing in the line.Once the blood enters the reservoir, any air bubbles should make their way to the surface and into the vent bag.The run data file (rdf) was analyzed for this event.Review of the run data file confirms that the disposable set was loaded successfully and passed the disposable set test.The access pressure sensor (aps) graph during the disposable set test looked normal.Priming of the disposable set and the first full draw cycle was successful, no alerts or alarms were generated.The low and high level sensors display an expected pattern during blood prime, first draw cycle and the first return cycle.The operator chose to discontinue the procedure at the beginning of the second draw cycle.The run data file analysis did not conclusively identify the cause of air being in the return line reported by the customer.Potential causes for air being present in the tubing set include but are not limited to: line of the sample pouch on the donor line not fully closed prior pressing start button; residual air being pulled from the 3-1 manifold; a manufacturing defect may have been present on the tubing kit investigation is in process.A follow up report will be provided.

Event Description

The customer reported that during a trima procedure there was air observed in the disposables set being returned to the donor, resulting in an air embolism.The donor identifier (id), age and outcome is not available at this time.Donor gender and weight were obtained from the run data files.The trima collection set is not available for return because it was discarded by the customer.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.Investigation: during follow-up, the customer reported that no blood warmer was connected for this event.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Updated investigation: terumo bct carried out similar test runs with (acda and saline) on another 82321 disposables set and observed small air bubbles in the return line tubing.It was determined that the air bubbles are an artifact of using crystalloid solutions during the saline run.The crystalloid solutions continued to outgas in the return line as the temperature of the contents equilibrated to the ambient temperature.Per trima¿s design, after the donor has been connected, the inlet pump primes the inlet line.Then, the return pump runs backward and primes the return line into the reservoir.That is how the trima ensures that no air is returned to the donor and how it prevents it.As it is pulling the blood directly from the donor, there shouldn't beany air entering the line, and therefore, residing in the line.Once the blood enters the reservoir,any air bubbles should make their way to the surface and into the vent bag.Root cause: a definitive root cause could not be determined.Potential causes for air being present in the tubing set include, but are not limited to:- line of the sample pouch on the donor line not fully closed prior pressing start button.- failure to prime the return needle to the 3-in-1 manifold, resulting in air in set.- an unidentified manufacturing defect on the tubing kit, resulting in a leak.

Event Description

The customer reported that no medical intervention was required and the donor was reported as having no adverse effects.Due to eu personal data protection laws, the patient information is not available from the customer.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL LRS PLATELET, AUTO PAS, PLASMA SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10810 w collins ave; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 8261303
• MDR Text Key: 135509234
• Report Number: 1722028-2019-00020
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: BK180231
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2020
• Device Catalogue Number: 82321
• Device Lot Number: 1809252130
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 01/22/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2018
• 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 Weight: 84