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

Catalog Number 80350

Device Problems Air Leak (1008); Device Operational Issue (2914)

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

Event Date 06/13/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation: the run data file (rdf) was analyzed for this event.Review of the rdf confirmed that there numerous access pressure alerts from the start of the procedure.Analysis of the pressure signals showed that the venous pressure remained at the alert limit for the first several minutes of the procedure.Based on the time between the alerts, it is possible that the operator attempted to sterile connect a new needle while the system was in blood prime.The trima operator¿s manual states not to connect a new needle during blood prime due to the risk of returning air to the donor.It is possible this scenario contributed to the reported air in the return line.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that after prime of the collection procedure, they observed air in the return line tubing and noticed that the reservoir was full.The operator stopped and aborted the procedure.Per the customer, no clots were observed in the collection set and the patient is 'well' without injury.The customer declined to provide patient's id and age.Terumo bct is awaiting return of the disposable set for evaluation.

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

Event Description

The collection 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: photographs were provided by the customer.Upon photographic inspection, it was noted that there was both air and blood in the return line at the time that the procedure was ended.Root cause: a definitive root cause could not be determined.Possible causes include but are not limited to:- leak in return line or return header that under negative pressure pulls air into set- based on the run data file analysis, there were numerous access pressure alerts from the start of the procedure.Analysis of the pressure signals showed that the venous pressure remained at the alert limit for the first several minutes of the procedure.Access pressure alerts this early in the procedure are generally indicative of the venous access requiring adjustment.Based on the time between the alerts, it is possible that the operator attempted to sterile connect a new needle while the system was in blood prime, which could cause air in the return line.

• 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: 6688456
• MDR Text Key: 79278675
• Report Number: 1722028-2017-00279
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: BK140180
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2018
• Device Catalogue Number: 80350
• Device Lot Number: 04Z3104
• Other Device ID Number: 05020583803503
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/31/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2016
• 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: 82