MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA ACCEL LRS PLATELET SAMPLER AUTOPAS RBC SET

Catalog Number 82420

Device Problems Device Displays Incorrect Message (2591); Gas/Air Leak (2946); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Patient Involvement (2645)

Event Date 10/04/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation: an unused trima accel set was returned to terumo bct for investigation.The set was visually inspected for misassembles, occlusions, leak locations or defects that could have contributed to the reported incident - none were identified.The customer radio frequency (rf) sealed the orange ac line tubing approximately 8cm from the filter inlet.The sample bag did not appear inflated on set receipt.The set was loaded onto a trima machine in the lab with clamps in their "as found" position -white pinch sample line clamp - closed white donor line clamp - closed blue inlet line clamp - closed yellow tpas line clamp- closed the set passed the pressure test and the sample bag did not inflate.The set was unloaded and the pressure test was re-run with the blue pinch clamp open.Upon start of the re- test a pressure test error alarm occurred.Additionally, the sample bag filled with air which indicates that the white sidewall clamp did not completely occlude the tubing.Corrective action: an internal capa has been initiated to evaluate the sidewall pinch clamp.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that during the loading of the disposable set on a trima device, apressure alarm occurred.The customer tried to load the machine again with the same set, butthe same alarm occurred.Upon receipt and evaluation testing by terumo bct of the trima set, the set was loadedand the pressure test was re-run with the blue pinch clamp open.Upon start of the re-test apressure test error alarm occurred.Additionally, the sample bag filled with air which indicatesthat the white sidewall clamp did not completely occlude the tubing.No donor was connected at the time of the event.Eu personal data protection laws are inplace for this event.This product is not available within the us, but this report is being filed due to an alleged failurethat could occur on a similarly marketed device platform cleared for use by the fda.

Manufacturer Narrative

This report is being filed to provide additional information.Corrected information is provided.Investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Correction: customer acknowledged that they are very trained and aware.No additional training was required.Corrected 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.

Manufacturer Narrative

This report is being filed to provide additional information in h.6, h.7 and h.10.Corrected information is provided in a.1, b.5 and e.1.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.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.

Event Description

No donor was connected at the time of the event, therefore, no donor information is available.Eu personal data protection laws are in place for this event.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL LRS PLATELET SAMPLER AUTOPAS RBC SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 9296373
• MDR Text Key: 189089426
• Report Number: 1722028-2019-00334
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup
• Report Date: 11/08/2019

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: 03/01/2021
• Device Catalogue Number: 82420
• Device Lot Number: 1903122230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2019
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 10/17/2019
• Initial Date FDA Received: 11/08/2019
• Supplement Dates Manufacturer Received: 11/25/2019; 12/30/2019
• Supplement Dates FDA Received: 12/03/2019; 01/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other