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

Catalog Number 000000000000080300

Device Problems Improper or Incorrect Procedure or Method (2017); Device Displays Incorrect Message (2591)

Patient Problem No Information (3190)

Event Date 09/16/2014

Event Type  malfunction  

Event Description

The customer reported that they received a 'centrifuge pressure high' alarm after a venipuncture.The operator noticed that they had not closed the clamp of the sample bag.The operator ended the procedure.Is it not known at this time if medical intervention was required for this event.Patient information is not available at this time.The disposable kit is not available for return because it was discarded by the customer.This report is being filed due to device malfunction in the form of operator error that has the potential for injury.

Manufacturer Narrative

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

Manufacturer Narrative

Additional information: a terumo bct representative conducted training with the customer, regarding methods to use when receiving 'centrifuge pressure high' alarm messages and mitigate risk of 'air to donor issues'.

Manufacturer Narrative

Investigation: this disposable set was unavailable for return.The run data file was not provided; unable to confirm the specific alarm experienced.Root cause: based on the details provided, forgetting to close the sample bag clamp is a possible cause of a centrifuge pressure high alarm, but it is not likely.Other possible causes include but are not limited to:- obstruction or air block inside tubing set- channel on tubing set is not properly installed- channel loop is twisted or rbc line into channel is kinked- defective or mis-calibrated centrifuge pressure sensor- defective control board.

Event Description

No safety issue occurred with this event, and no medical intervention was reported.

Manufacturer Narrative

Investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Customer's problem description and information from the terumo bct product support and training manager indicate that the centrifuge pressure high alarm was caused by the operator forgetting to close the sample bag clamp.This indicates potential risk of air embolism related to air in sample bag.Root cause: based on the customer's problem description and information from the product support and training manager, forgetting to close the sample bag is a possible cause for the centrifuge pressure high alarm which ended the run.Correction: a voluntary medical device product recall was released by terumo bct on (b)(6) 2014 to communicate more information about the "air in the sample bag safety alert" corrective action: an internal capa has been initiated to address air in sample bag issues.

Event Description

The customer declined to provide the patient's information.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL PLATELET, PLASMA SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: jessica kim ; 10811 w. collins ave; lakewood, CO 80215 ; 3032314812
• MDR Report Key: 4267162
• MDR Text Key: 5028660
• Report Number: 1722028-2014-00473
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: CN
• PMA/PMN Number: BK120049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Health Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/30/2014

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: 01/01/2016
• Device Catalogue Number: 000000000000080300
• Device Lot Number: 01W2111
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/09/2015
• Initial Date FDA Received: 11/20/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 12/12/2014; 01/07/2015; 01/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2014
• 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