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

Catalog Number 80350

Device Problems Device Displays Incorrect Message (2591); Human-Device Interface Problem (2949)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/14/2018

Event Type  malfunction  

Manufacturer Narrative

Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that during the first return cycle of a procedure, they received a "system test failure - return cycle took too long to empty the reservoir" alarm.Per the customer the venipuncture appeared good, however, the flow rate was in the yellow and they believed that there may have been clotting in the draw line due to the venipuncture.The procedure was terminated and the donor was disconnected.Patient outcome and information are not available at this time.The disposables set is not available for return because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provide additional information.Investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Per the information provided by the customer there is no evidence to suggest there was a malfunction with the trima system.Terumo bct customer support informed the customer that a clot might have contributed to the alarm or an air block or partial obstruction.However, the customer stated that there was no infiltration and the person doing the procedure did not see any clots in the draw line when the needle was removed.Root cause: a definitive root cause could not be determined.Possible causes include but are not limited to:- centrifuge was stopped.- air block in the plasma line.- partial obstruction in the return line.- defective lower level sensor.- defective safety/ultrasonics cca.- defective return rotor occlusion.- defective control cca.

Manufacturer Narrative

This report is being filed to provide additional information.Investigation: per customer, no clots were observed in the draw line.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that during the first return cycle of a platelet collection procedure, they received a "system test failure - return cycle took too long to empty the reservoir" alarm.Per customer ,the procedure ran with multiple ¿low draw¿ alarms for approximately 6 minutes and after repositioning the needle, no infiltration is observed.The operator followed the prompts, stopped the procedure and disconnected the donor.The customer further stated that post donation instructions were provided to the donor and a pressure bandage was applied at the venipuncture site.The customer declined to provide patient identifier (id) and outcome.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL PLATELET, PLASMA, RBC, AUTO RAS SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10810 w. collins ave.; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 7582921
• MDR Text Key: 110875137
• Report Number: 1722028-2018-00158
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK170059
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/08/2018

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: 03/01/2020
• Device Catalogue Number: 80350
• Device Lot Number: 1803272230
• Other Device ID Number: 05020583803503
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 05/14/2018
• Initial Date FDA Received: 06/08/2018
• Supplement Dates Manufacturer Received: 06/13/2018; 09/06/2018
• Supplement Dates FDA Received: 07/03/2018; 09/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2018
• 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 Age: 58 YR
• Patient Weight: 109