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)

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

Event Date 07/21/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation: the run data file (rdf) was analyzed for this event.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 used collection set contained with blood was returned without product bags.The set was visually evaluated for any misassembly, obstruction, or other defect with no anomalies observed.The white and blue pinch clamps were found completely closed and the tubing lines was sealed off just above each clamp.The sample bag and access needle were not returned for evaluation.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that the operator setup and started a collection procedure.While the operator opened the clamps during the procedure, the operator noticed that as the blood flowed into the sample bag, it started to fill with air.The customer stated that they continued the procedure for approximately 16 minutes until per manager's order, the procedure was ended.No medical intervention was required for this event.Per the customer, no air was returned to the patient (donor) and the donor is 'okay'.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 to provide additional information.Investigation: the customer provided a photograph of the sample bag.Upon photographic inspection, it was confirmed that the sample bag was inflated with the donor connected and there was a small amount of blood noted in the sample bag.Root cause: 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 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.

Manufacturer Narrative

This report is being filed to 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: 6790296
• MDR Text Key: 82789723
• Report Number: 1722028-2017-00326
• 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: 03/01/2019
• Device Catalogue Number: 5804001
• Device Lot Number: 1703015451
• 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: 03/02/2017
• 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: 92