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

Catalog Number 80337

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Patient Involvement (2645)

Event Date 02/19/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation: terumo bct sales representative performed troubleshooting by reloading the disposable set to another trima machine.He received a 'failure to pressurize' alarm and noted that the white pinch clamp was improperly closed on the sample bag.The run data file (rdf) was analyzed for this event.Review of the rdf showed that the ¿tubingset type error¿ alert was generated during the disposable test as the pressure value did not increase as expected, indicating to the system that a different tubing set was loaded than selected.The complaint report stated that the clamp on the sample bag was not closed correctly as air entered the sample bag, which confirms one of the known causes for this alert to be generated.Upon reloading of the kit, the ¿failure to pressurize¿ alert was generated during the disposables test.This alert is generated when the system is unable to reach and maintain maximum positive pressure in the kit which can also be caused by the sample bag line clamp not being fully occluded.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Root cause: based on the available evidence, the root cause for the inflated sample bag was due to the clamp being engaged by user, but the clamp was not fully occluding the sample bag line.Corrective action: an internal capa has been initiated to evaluate reports of air in sample bag.

Event Description

The customer reported that during prime for a collection procedure, they received a ¿tubing settype¿ error alarm and noted air in the sample bag.Per the customer, the technician stated that they closed the white and red pinch clamps correctly.No patient (donor) was connected at the time of the event.No patient (donor) information is reasonably known.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

Updated root cause: based on the available evidence, the root cause for the inflated sample bag was not able to be determined.Possible causes include but are not limited to:-the user did not close the clamp when prompted to do so-the user closed the clamp but the clamp was not fully occluding the sample bag line.Root cause: review of the run data file showed that the ¿tubing set type error¿ alert was generated during the disposable test as the pressure value did not increase as expected,indicating to the system that a different tubing set was loaded than selected.The complaint report stated that the clamp on the sample bag was not closed correctly as air entered the sample bag, which confirms one of the known causes for this alert to be generated.Upon reloading of the kit, the ¿failure to pressurize¿ alert was generated during the disposables test.This alert is generated when the system is unable to reach and maintain maximum positive pressure in the kit which can also be caused by the sample bag line clamp not being fully occluded.Based on the available evidence, the root cause for the inflated sample bag was not able to be determined.Possible causes include but are not limited to:-the user did not close the clamp when prompted to do so-the user closed the clamp but the clamp was not fully occluding the sample bag line.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL PLATELET, PLASMA SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10810 w. collins ave; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 6414759
• MDR Text Key: 70352519
• Report Number: 1722028-2017-00086
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• 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: 03/17/2017

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: 10/01/2018
• Device Catalogue Number: 80337
• Device Lot Number: 10Z0306
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/21/2017
• Initial Date FDA Received: 03/17/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2016
• 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