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

Catalog Number 80330

Device Problems Air Leak (1008); Improper or Incorrect Procedure or Method (2017)

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

Event Date 11/11/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation: the run data file (rdf) was analyzed for this event.Run data file analysis showed the tubing set test completed with no alerts generated.All signals appeared as expected with no anomalies noted.It is possible, though not conclusive, the tubing set used in the previous rdf where a ¿pressure test error¿ alert was generated may have also been used for this procedure.The ¿pressure test error¿ alert indicated that the operator did not close the sample bag and/or needle line clamps at the system prompt.If the sample bag clamp was not closed, a small amount of air will enter the sample bag during the verification of clamp closure at the beginning of the tubing set test.It is possible, though not conclusive, the operator did not express the small amount of air that entered the sample bag during the prior procedure and therefore a small amount of air was in the sample bag when the donor was connected.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that after a donor was connected for a collection procedure, the operator observed air entering the sample bag as it was filling with blood.The operator clamped the sample bag and also noted air in the donor line.The operator then chose to stop and end the procedure.Patient (donor) outcome is not available at this time.This product is not available within the u.S., but this report is being filed due to an alleged failure that could occur on a similarly marketed device platform cleared for use by the fda.The collection set is not available for return because it was discarded by the customer.

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.A photograph was provided by the customer.Upon review of the photograph, blood was observed in the sample bag with a bubble of air.It was also observed that a segment of tubing contained with blood and air was removed from the set displayed near the donor needle line.Root cause: the ¿pressure test error¿ alert in the first procedure indicated that the operator either did not close the sample bag and/or needle line clamps at the system prompt or they did close the clamp but it was skewed on the tubing allowing a portion of tubing to allow air to pass.A small amount of air will enter the sample bag during the verification of clamp closure at the beginning of the tubing set test if the sample bag clamp is not fully closed.It is possible, though not conclusive, the operator did not express the small amount of air that entered the sample bag from the first procedure as prompted by the screen and therefore a small amount of air was left in the sample bag when the donor was connected during the second procedure.Corrective action: an internal capa has been initiated to evaluate reports of air in sample bag.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL LRS PLATELET, PLASMA SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10811 w. collins ave; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 6149677
• MDR Text Key: 62189856
• Report Number: 1722028-2016-00634
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: BK150321
• 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
• Report Date: 12/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2018
• Device Catalogue Number: 80330
• Device Lot Number: 08Z1104
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2016
• 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 Age: 00052 YR
• Patient Weight: 74