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

Catalog Number 80400

Device Problems Device Alarm System (1012); Improper or Incorrect Procedure or Method (2017); Device Displays Incorrect Message (2591)

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

Event Date 08/10/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation: a trima platelet collection set with the channel and platelet bag removed was returned for investigation.Upon visual inspection, it was observed that the customer had sectioned off the return line to preserve evidence of the observed air to blood ratio.The set was visually inspected for any misassemblies or defects.It was noted that the upper bearing had not been locked to the ears on the upper loop sleeve.Witness line on the lower hex indicated that the hex was locked and properly loaded.It was observed that the return reservoir had some foaming/bubbles, and was approximately half way full.Through inspection of the loop, it was noted that customer likely performed a rinse back since the 4 lumen tubing at the lower hex all were filled with clear fluid with a light yellow coloration.The return line on the 4 lumen tubing had some signs of clotting.There was evidence of sterile docking on both the donor line and the sample line.The run data file (rdf) was analyzed for this event.The analysis did not find any conclusive cause for air in the return line.No unusual process variable was identified and the trima accel system operated as intended.Investigation is in progress.A follow-up report will be provided.

Event Description

The customer reported that during a platelet collection procedure, they received multiple alarms including 'draw pressure too low', and 'return pressure too high' alarms.They determined the venipuncture was unsuccessful.The operator paused the procedure and sterile docked a new needle to the platelet collection set.After the 2nd venipuncture of the platelet donor, they received a 'level sensor error' alarm and noticed air in the return line.The operator stopped and discontinued the procedure.No medical intervention was required for this event.Per the customer no air was returned to the patient (donor) and the patient (donor) is 'fine'.Patient (donor) identifier and age are not available at this time.

Manufacturer Narrative

A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Per the customer, there have been no further similar issues on the machine.The analysis did not find any conclusive cause for air in the return line.No unusual process variable was identified and the trima accel system operated as intended.It is possible that the set was not fully primed prior to the procedure.

Event Description

The customer declined to provide patient identifier and age.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL PLATELET, PLASMA, RBC SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: matthew bickford ; 10810 w collins ave; lakewood, CO 80215 ; 3032052494
• MDR Report Key: 5923336
• MDR Text Key: 54460086
• Report Number: 1722028-2016-00495
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK150321
• 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
• Report Date: 09/01/2016

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: 07/01/2018
• Device Catalogue Number: 80400
• Device Lot Number: 07Z3305
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/10/2016
• Initial Date FDA Received: 09/01/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2016
• 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: 66