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

Catalog Number 000000000000080400

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 12/03/2014

Event Type  Injury  

Event Description

The customer reported that during the first return cycle of a triple platelet collection procedure, they received multiple alarms including 'system test failure' alarm.While the operator disconnected and removed the needle from the donor's arm, they noted a 'long' blood clot removed with the needle.No medical intervention was necessary for this event and no additional follow-up visit was required.Patient (donor) full identifier: (b)(6).The disposable kit is not available for return because it was discarded by the customer.This report is being filed due to the potential for injury if the same failure were to reoccur.

Manufacturer Narrative

Investigation: per the customer, they had difficulties with the venipuncture and noticed slow blood flow during the procedure.Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

Additional information: the apheresis manager was contacted to determine if the facility wanted re-training, regarding techniques to optimize the venipuncture procedure.The customer declined the re-training.

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.The run data file (rdf) was analyzed for this event.There were no indications in the file for why there would have been clotting in the return line.The trima system operated as intended.Root cause: the set was not available for return and analysis.The rdf analysis shows multiple low aps pressure alerts during the procedure.Additionally, customer statements indicate that the cause for the blood clot, alerts, and alarm are related to slow blood flow from poor venipuncture.

Manufacturer Narrative

This record was identified during a retrospective review of mdr's to identify records in which an event occurred, but the type of reportable event was not indicated appropriately in the mdr form.This supplement is being filed to modify information in and to align with the reported event.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL PLATELET, PLASMA, RBC SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: jessica kim ; 10811 w. collins ave; lakewood, CO 80215 ; 3032314812
• MDR Report Key: 4358576
• MDR Text Key: 16178397
• Report Number: 1722028-2014-00518
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK140158
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2016
• Device Catalogue Number: 000000000000080400
• Device Lot Number: 09W2114
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/21/2015
• Initial Date FDA Received: 12/23/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 01/16/2015; 01/23/2015; 07/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/17/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 50 YR
• Patient Weight: 75