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

Catalog Number 80440

Device Problems Use of Device Problem (1670); Device Displays Incorrect Message (2591); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Patient Involvement (2645)

Event Date 05/04/2019

Event Type  malfunction  

Manufacturer Narrative

Additional method codes: 4110 trend analysis, 4109 historical data analysis investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.A photograph was submitted in lieu of the disposable set to aid in the investigation.Visual analysis of the image revealed an unused trima set loaded on a trima machine.Air is confirmed in the sample bag and the pinch sidewall clamp to the sample bag appears to be closed with no evidence of skewed tubing observed.Air in the sample bag is consistent with an operator error where the operator does not close the clamps when prompted to do so by the machine.Failing to clamp the sample bag line when prompted results in failure to occlude the line and air entering the sample bag.Based on the evidence found in the photograph, the root cause of the reported failure was clamping error by the operator.Per the procedure summary, there were 2 pressure test errors - failure to pressurize inlet alerts which prompted the operator to verify that there was not any air in the vent bag and if so, to express the air.The terumo bct clinical specialist spoke with the customer and told the customer it appears to be an operator error - not expressing the air in the sample pouch as prompted.Correction: customer stated that they have addressed the issue with their staff on (b)(6) 2019 - no additional training required.Corrective action: an internal capa has been initiated to evaluate the sidewall pinch clamp and air in the sample bag.Investigation is in process.A follow-up report will be provided.This report was filed beyond the 30-day timeframe due to an internal processing error.An internal capa has been initiated to address the issue.

Event Description

The customer reported that during the disposable testing on the trima device they received alarm 61-"air removal failure - pressure detected".Upon inspection by the customer, it was found that the clamps were closed but the sample pouch was inflated with air.Per the customer the procedure was ended.No patient (donor) was connected at the time of the event, therefore, no patient information is known.The platelet collection set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Updated investigation: a photograph was submitted in lieu of the disposable set to aid in the investigation.Visual analysis of the image revealed an unused trima set loaded on a trima machine.Air is confirmed in the sample bag and the pinch sidewall clamp to the sample bag appears to be closed with no evidence of skewed tubing observed.Based on the evidence found in the image provided, a definitive root cause of this failure could not be determined.Possible causes include but are not limited to operator error or defective clamp.Root cause: based on the customer's statement and evaluation of the returned set, the root cause is determined to be an operator error, where the sample bag clamp was not closed at the system prompt.

Manufacturer Narrative

This report is being filed to provide additional information in h.7 and h.10.Corrected information is provided in h.6 and h.10.Correction: trima field action 35 has been initiated to notify all trima users of a potential safety hazard occurs if the system displays an alert and instructions are not observed and followed.Terumo bct is taking corrective action by reminding all users of the action to be taken to mitigate this risk.Alerts and instructions are presented to the operator if the sample bag inflates.Terumo bct instructs all trima users to provide supplementary training and to continue to use the trima accel system in accordance with the operator¿s manual.Corrected root cause: specific root cause could not be definitively determined for this incident.Possible causes include: a clamp malfunction where the clamp skews to the side as it is closed, or the clamp does not fully occlude the tubing when closed due to interference between the clamp and the tube.Additional contributing factors could be related to user interface, where either the sample bag clamp was not closed at the system prompt or the clamp was closed but it was skewed on the tubing enabling a portion of the tubing to allow air to pass.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL PLATELET, SAMPLER, PLASMA, RBC SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 9363693
• MDR Text Key: 188115516
• Report Number: 1722028-2019-00368
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583804401
• UDI-Public: 05020583804401
• Combination Product (y/n): N
• PMA/PMN Number: BK180231
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup
• Report Date: 11/22/2019

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: 01/01/2021
• Device Catalogue Number: 80440
• Device Lot Number: 1901244151
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 05/06/2019
• Initial Date FDA Received: 11/22/2019
• Supplement Dates Manufacturer Received: 12/30/2019; 12/30/2019
• Supplement Dates FDA Received: 12/16/2019; 01/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other