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

Catalog Number 5804001

Device Problems Air Leak (1008); Improper or Incorrect Procedure or Method (2017); Inadequate User Interface (2958)

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

Event Date 07/20/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation: the run data file (rdf) was analyzed for this event.Signals in the rdf indicates that the trima accel system operated as intended by displaying the ¿pressure test error¿ alert when the system could not maintain pressure during the disposables test.The signals in the rdf 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 the white clamp on the sample line was partially open possibly allowing air to enter the sample bag before the donor was connected.It is also possible that the inlet, ac, or return pump header was not loaded correctly.A partially primed collection set was returned without product bags for investigation.Upon visual inspection, it was noted that the access line was sealed and the clamps and tubing of the access needle and sample line were not returned.Fluid had circulated into the cassette via the ac spike line.The fluid had not yet made it into the channel to prime the remainder of the set.The disposable was visually evaluated for any misassembly, obstruction, leak or other defect with no anomalies found.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that post-phlebotomy of the donor, the operator started a collection procedure.While the operator opened the clamps during the procedure, he heard a 'gurgling' sound and noticed that the sample bag filled with air.The operator stopped the procedure and disconnected the donor.Full patient (donor) identifier: (b)(6).The customer declined to provide patient (donor) age.Terumo bct is awaiting return of the disposable set for evaluation.

Manufacturer Narrative

This report is being filed tp provide additional information.Root cause: the signals in the run data file and the returned product investigation 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 the white clamp on the sample line was open or partially open possibly allowing air to enter the sample bag before the donor was connected.It is also possible that the inlet, ac, or return pump header was not loaded correctly.Additionally, based on the state of the returned set and the run data file analysis, a donor should not have been connected to the device yet.Premature connection of the donor to the system can lead to an unintended air to donor event if the clamps are not completely closed.

Manufacturer Narrative

This report is being filed tp 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.Investigation is in process.A follow-up report will be provided.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL PLATELET, PLASMA, RBC SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10810 w. collins ave; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 6789823
• MDR Text Key: 83111593
• Report Number: 1722028-2017-00325
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162365
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2019
• Device Catalogue Number: 5804001
• Device Lot Number: 1702155151
• Other Device ID Number: 05020583804005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2017
• 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: 84