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

Catalog Number 80400

Device Problem Improper or Incorrect Procedure or Method (2017)

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

Event Date 08/07/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Sterilization process review investigation: a review of the device history record for this lot showed no irregularities during manufacturing that were relevant to the air being returned to the donor as the customer experienced.A used trima accel set containing prime solution was returned for investigation.It was noted prime fluid had only circulated into the inlet coil, automatic pressure sensor (aps) sensor and filter.Fluid had not reached the inlet pump header tube leading to the loop and channel.The sample bag and sample bag line were not provided for analysis, therefore it is inconclusive how much air may have been in the sample bag.The blue pinch clamp on the donor line was closed upon set receipt.No signs of puckering were noted in the tubing at this location.Flow testing was conducted and no fluid occlusions were encountered.The remainder of the set was visually inspected for kinks, occlusions, missing parts, misassembly and leaks.No manufacturing abnormalities were found.All pressure sensors were inspected and no defects were found.The tubing from the donor line was removed from the set for dimensional analysis.All dimensional specifications for outside and inside diameter as well as wall thickness were measured and all measurements were within specification.Based on previous similar incidents, if the operator does not close the clamps on the trima accel system when instructed by the system, or if the clamps do not properly occlude the tubing during the tubing set test, air may be introduced into the sample bag.If this occurs,the trima accel system will alert the operator to a failure during the tubing set test.This alert will instruct the operator either to express air from the sample bag if it is inflated, or to verify that no air is in the sample bag.The run data file (rdf) was analyzed for this event.The signals in the rdf indicate that during the first two loading attempts, the disposable tests took longer than expected during the disposable test substates and the trima accel system operated as intended by displaying pressure test error alerts during both loading attempts (two during the first, one during the second).While this does not indicate a conclusive cause for air in the sample pouch or return line, the system running the pumps longer in order to achieve the specific criteria can indicate that the tubing set may not have been clamped or loaded correctly.Root cause: the customer did not provide the portion of the disposable set (tubing, clamp,or sample bag) with the alleged issue of air in sample bag.The rest of the set was analyzed and there were no manufacturing anomalies found.The rdf analysis indicates that the operator received alerts during loading tests about air in the system.While inconclusive to the cause, the trima accel system operated as intended by displaying the pressure test error alerts.Possible causes for the inflated sample bag and return of air to the donor include but are not limited to the user not following prompts to clamp the tubing, user not looking for and then expressing air from sample bag when system alarms for pressure test error alerts, or clamp was engaged by user but the clamp was not fully occluding the sample bag line.Corrective/preventive action: an internal capa has been initiated to address air in sample bag issues.

Event Description

The customer reported that when the operator performed a phlebotomy for apheresis donation, they noted that when they opened the clamps as prompted, the blood flow reversed flow and a small amount of air went back to the donor.Full patient (donor) id: (b)(6).The customer declined to provide the donor's date of birth.The donor is in healthy stable condition following the incident.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL PLATELET, PLASMA, RBC SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: matthew bickford ; 10810 w collins ave; lakewood, CO 80215 ; 3032052494
• MDR Report Key: 5917947
• MDR Text Key: 53672848
• Report Number: 1722028-2016-00490
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK150321
• 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
• Report Date: 08/31/2016

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: 07/01/2018
• Device Catalogue Number: 80400
• Device Lot Number: 07Z2108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/10/2016
• Initial Date FDA Received: 08/31/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2016
• 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