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

Catalog Number 80440

Device Problem Air Leak (1008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/07/2015

Event Type  malfunction  

Manufacturer Narrative

Investigation: the operator stated that after loading and priming the trima, the disposable set did not pass the tubing set test, so the operator proceeded to clean the sensors and reloaded the set.The set passed the test this time.The operator proceeded to perform the phlebotomy but described the sample bag as having excess air.The disposable set was returned for further investigation.It was noted that the sample bag contained about 10ml of blood and was expanded with air.The exact pressure inside the bag is unknown but when the bag was pressed by hand there was not very much slack in the vinyl and it seemed fairly taut.A ruler was positioned next to the bag and the bag was inflated to a little over 1.25" from the table surface.The inlet coil had numerous air bubbles in the ac and inlet lines.Prime fluid was not observed passed where the inlet line gets bonded to the cassette.The remainder of the cassette beyond this point was not primed with fluid and was dry.The return line in the coil had air bubbles in the line about 12" from the 3:1 manifold but it is suspected that it was due to fluid movement back through the manifold during return shipping of the kit as the remainder of the disposable system was dry and had not been primed yet.The run data file (rdf) was analyzed for this event.The trima accel system operated as intended by displaying the ¿pressure test error¿ alerts when the system could not maintain pressure during the disposables test.At this time, the system prompted the operator to verify: the white clamps on the donor line are closed and there is no air in the sample bag.The pump headers are loaded correctly.The cassette is loaded correctly and there are no obstructions.¿.The signals in the run data file do not indicate a conclusive cause for the air in the sample bag reported for this procedure.Based on the available information, it is possible that there could have been an arterial phlebotomy.It is also possible that the white clamp on the sample line was partially open possibly allowing air to enter the sample bag.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that after the phlebotomy of the donor, the operator noticed excessair in the sample bag.The operator chose not to initiate the procedure as they were concerned about the amount of air in the sample bag.They then unloaded the disposable set and noted some segmentation of the fluid inside the set.No medical intervention was required for this event.Per the customer, the donor is in 'healthy' condition.

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.Root cause: the evaluation of the disposable found no cause for the air in the system.The signals in the run data file do not indicate a conclusive cause for the air in the sample bag report for this procedure.Based on the available information, it is possible that there could have been a arterial phlebotomy.It is also possible that the white clamp on the sample line was partially open possibly allowing air to enter the sample bag.An internal capa has been initiated to address air in the sample bag events.A voluntary medical device product recall was released by terumo bct on (b)(6) 2014 to communicate more information about the "air in the sample bag safety alert".

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL ENHANCED PLATELET, PLASMA, RBC SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: glenda o'neill ; 10810 w. collins ave; lakewood, CO 80215 ; 3032314051
• MDR Report Key: 5125349
• MDR Text Key: 27584861
• Report Number: 1722028-2015-00571
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK140180
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Followup,Followup
• Report Date: 09/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2017
• Device Catalogue Number: 80440
• Device Lot Number: 07Y4109
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2015
• 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 Age: 66 YR
• Patient Weight: 61