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

Catalog Number 82321

Device Problems Improper or Incorrect Procedure or Method (2017); Device Operates Differently Than Expected (2913)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 09/27/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation: the trima donation set was returned for investigation.Visual inspection confirmed the set was assembled correctly with no leaks, kinks, occlusions or missing parts.Flow of ac was verified throughout the inlet coil, although was frequently interspersed with air.All pinch clamps on the donor, inlet and sample lines were confirmed as closed and were fully occluding the tubing.Around 10ml of blood was present in the sample collection bag.The bag appeared inflated and the volume of air in the sample bag was measured at 30-35ml.The rdf was analyzed for this event.The rdf analysis showed that the ¿pressure test error¿-alert was generated in this procedure.The rdf did not show a conclusive root cause for what generated this ¿pressure test error¿-alert, however, it is possible the pinch clamp on the sample bag line was not occluding the line properly.If the clamp on the sample bag line is not occluding properly during the tubing set test, air can have a pathway to enter the sample bag.Rdf analysis did not show that the operator opened the clamps to remove air from the sample pouch after the alert was shown.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that after the venipuncture of a patient (donor), the operator opened the 2 white clamps and noticed the sample bag filled with air and small amount of blood.Air was also noted in the return line below the closed blue clamp.The start button for the procedure had not been pressed.The operator stopped the donation immediately and clamped the tubing and removed the needle.Donor outcome is not available at this time.Patient (donor) identifier and age are not available at this time.Patient (donor) gender and weight were obtained from the run data file (rdf).This product is not available within the us, 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.

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.Root cause: root cause remains undetermined at this time.If the operator does not close the clamps on the trima accel system when instructed by the system, or if the clamps do not properly occlude the tubing during the tubing set test, air may be introduced into the sample bag.If this occurs, the trima accel system will alert the operator to a failure during the tubing set test.This alert will instruct the operator either to express air from the sample bag if it is inflated, or to verify that no air is in the sample bag.Information screens that are accessible from the alert screen will instruct the operator how to express air if the sample bag is inflated.Corrective action: an internal capa has been initiated to evaluate reports of air in sample bag.

Event Description

Due to eu personal data protection laws, the patient information and outcome are not available from the customer.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL LRS PLATELET, + AUTOPAS, 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: 6063614
• MDR Text Key: 59025834
• Report Number: 1722028-2016-00579
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: GB
• 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,Followup
• Report Date: 10/28/2016

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: 06/01/2018
• Device Catalogue Number: 82321
• Device Lot Number: 06Z9119
• Other Device ID Number: 05020583823211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/03/2016
• Initial Date FDA Received: 10/28/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/19/2016; 12/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2016
• 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 Weight: 132