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

Catalog Number 82321

Device Problems Air Leak (1008); Device Operates Differently Than Expected (2913)

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

Event Date 04/27/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported seeing air bubbles in the return line after priming for the collection procedure.Patient (donor) outcome is unknown at this time.Full patient (donor) id: (b)(6).Patient age, gender, and weight are not available atthis time.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.Terumo bct is awaiting the return of the device for evaluation.

Manufacturer Narrative

Investigation: the inlet coil was returned for investigation.It contained anticoagulant (ac)only, no blood, confirming that no donor was attached.The ac line contained ac and some bubbles.No manufacturing defects were noted in the portion of the returned set.Investigation is in progress.A follow-up report will be provided.

Event Description

No donor was attached at the time that the air bubbles were seen, therefore, no patient information is reasonably known.

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.Further evaluation of this event has determined that the device did not cause or contribute to a death or serious injury, nor is there a likely potential for death or serious injury associated with this event based on additional investigational information.There was no donor connected at the time of the incident and the set was not used.Air bubbles were noticed in the return line by the operator after ac prime was complete.It should be noted that it is not atypical to have a modest volume of air in the return line at this point in the procedure.Directly following ac prime, the system completes the prime sequence with a blood prime sequence, which is a draw cycle that would draw air into the centrifuge, and would not return air to the donor.At the point in the procedure in which the customer noted air in the access/return line, it is not possible to return this air to the donor.Root cause: no malfunction or defect of the device was found as a result of the investigation of this incident with the available information.The air bubbles noted by the customer after the completion of the ac prime sequence are a normal and expected finding at this point in the procedure.

Manufacturer Narrative

Root cause: root cause for this incident remains undetermined at this time.No malfunction or defect of the device was found as a result of the investigation of this incident.Air bubbles noted by the customer after the completion of the ac prime sequence are not an unexpected finding at this point in the procedure.It is possible that this is simply the customer's perception of an excessive amount air.Additionally, another possible cause could be failure to squeeze the drip chamber on the acda.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL LRS,PLT, + AUTOPAS, PLASMA, SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: matthew bickford ; 10810 w collins ave; lakewood, CO 80215 ; 3032052494
• MDR Report Key: 5850291
• MDR Text Key: 52443159
• Report Number: 1722028-2016-00440
• 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,Followup
• Report Date: 08/05/2016

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: 03/01/2018
• Device Catalogue Number: 82321
• Device Lot Number: 03Z9109
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/12/2016
• Initial Date FDA Received: 08/05/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 08/22/2016; 11/19/2016; 12/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2016
• 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