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

Catalog Number 5803371

Device Problems Air Leak (1008); Device Operates Differently Than Expected (2913); Inadequate User Interface (2958)

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

Event Date 10/09/2017

Event Type  malfunction  

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

Event Description

The customer reported that during a collection procedure, they found the sample bag was filled with air.Per the customer, the operator noted that the white pinch clamp was closed.The customer stated that no medical intervention was necessary for this event as no air went to the donor, and the donor is 'ok'.Due to (b)(6) personal data protection laws, the patient information is not available from the customer.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

Investigation: terumo bct (b)(4), inc was not able to determine the root cause for the inflated sample bag.Terumo bct (b)(4), inc provided photographs of the set to tbct (b)(4) and it was confirmed that the sample bag was inflated and contained blood.It could not be determined if the white pinch clamp was fully closed on the tubing.The run data file (rdf) was analyzed for this event.Signals in the rdf showed a ¿pressure test error¿ alert was generated during the tubing set test while the system was attempting to positively pressurize the tubing set.It is suspected that this alert was generated because the pinch clamp on the sample bag line was likely not occluding the tubing properly.If the clamp on the sample bag line is not occluding the tubing properly during the tubing set test, air can have a pathway to enter the sample bag.Signals in the rdf also showed that after the operator continued from the ¿pressure test error¿ alert, the tubing set test passed.It is possible that after the ¿pressure test error¿ alert, the operator adjusted the clamp but did not express the air from the sample bag as the sample bag was inflated with a small amount of donor blood upon return to the terumo bct (b)(4), inc.Root cause: review of the run data file showed 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.Corrective action: an internal capa has been initiated to evaluate reports of air in sample bag.

Event Description

Patient (donor) gender and weight were obtained from the run data file (rdf).

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL PLATELET, PLASMA SET JAPAN
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10810 w. collins ave; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 6999824
• MDR Text Key: 92197370
• Report Number: 1722028-2017-00432
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• 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: 11/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2019
• Device Catalogue Number: 5803371
• Device Lot Number: 1706025251
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2017
• 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: 78