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

Model Number 80300

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Air/Gas in Device (4062)

Patient Problem Insufficient Information (4580)

Event Date 03/31/2022

Event Type  malfunction  

Manufacturer Narrative

Investigation: a photograph was submitted in lieu of the disposables set to aid in the investigation.The picture confirmed that there was a chain of air bubbles in the draw/return line.A disposable complaint history search was performed for this lot and found no reports for similar issues on this lot worldwide.The device history records (dhr) were reviewed for this lot.There were no events noted in the dhr that would have contributed to the air in return line experienced by the customer.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported air in the return line.The customer declined to provide patient information or outcome.

Manufacturer Narrative

This report is being filed to provide additional information in b.5, e.1, e.3, h.6 and h.10.Investigation: a photograph was submitted in lieu of the disposables set to aid in the investigation.The picture confirmed that there was a chain of air bubbles in the draw/return line.A disposable complaint history search was performed for this lot and found no reports for similar issues on this lot worldwide.The device history records (dhr) were reviewed for this lot.There were no events noted in the dhr that would have contributed to the air in return line experienced by the customer.Root cause: a root cause assessment was performed for this complaint.Based on the available information a definitive root cause could not be determined but it is likely due to one or a combination of the possible causes listed below: * foam from plasma drain is perceived as fluid by low level sensor resulting in microbubbles in return reservoir returned to donor during plasma flush causing air embolism to donor.* a defective lower level sensor.* obstructed low level sensor due to blood clots resulting in false detection of fluid rather than air leading to air to donor.

Event Description

The operator found air in the donor line during the run.The only option was to end the run.The customer declined to provide patient information or outcome.The disposables set is not available for return because it was discarded by the customer.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL PLATELET, PLASMA 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: 15123187
• MDR Text Key: 304606227
• Report Number: 1722028-2022-00244
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583803008
• UDI-Public: 05020583803008
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: BK190332
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 07/28/2022

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: 09/02/2023
• Device Model Number: 80300
• Device Catalogue Number: 5803001
• Device Lot Number: 2109145151
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2022
• Initial Date Manufacturer Received: 07/07/2022
• Initial Date FDA Received: 07/28/2022
• Supplement Dates Manufacturer Received: 07/30/2022
• Supplement Dates FDA Received: 08/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/03/2021
• 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