MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA ACCEL LRS PLATELET, PLT FILTER, AUTO PAS, PLASMA

Catalog Number 82383

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Gas/Air Leak (2946); Adverse Event Without Identified Device or Use Problem (2993); Pressure Problem (3012); Noise, Audible (3273)

Patient Problem No Patient Involvement (2645)

Event Date 12/03/2018

Event Type  malfunction  

Manufacturer Narrative

This report is being filed to provide additional information.Correction: upon follow from the customer, retraining was completed at the customer location.Per the customer a national efs¿s sop with critical point have been implement including the risk of air in the sampling bag.

Manufacturer Narrative

Investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.One unused trima disposable was returned to terumo bct for investigation.Initial observations noted that the donor needle had been rf sealed and removed from the disposable prior to return.The white pinch clamps to the donor line, sample bag and filter line were all observed to be in the closed position.The tubing set was loaded onto a trima device and the pressure test was commenced.The set passed without issue and continued onto the ac prime screen.The disposable was visually examined for any kinks, missing parts or other mis assembly and none were found.All clamps were noted to be effectively occluding the tubing lines.Flow throughout the ac line was tested and verified, and no issues were identified with the access pressure sensor (aps).Corrective action: an internal capa has been initiated to evaluate 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 an abnormal noise from the anticoagulant (ac) pump during the disposable set test on the trima device.Per the customer the clamp was closed on the sample bag line, however, there was a presence of air in the sample bag.The customer received an alarm for the failure of the pressure test and the device indicated to check the closing of the clamps and if air was present in the blood diversion bag.The customer confirmed that no collection took place as the issue was detected during the pressure test of the disposable set.No patient (donor) was connected at the time of the event.Therefore, no donor information is reasonably known.Eu personal data protection laws are in effect for this event.This product is not available within the us, but this report is being filed due to an alleged failure that could occur on a similarly marketed device platform cleared for use by the fda.

Event Description

Per the customer, no further procedural details for this event are available, including machine serial number.

Manufacturer Narrative

Investigation: during follow-up with the customer, they acknowledged they did not recall the incident and did not document any faults that occurred during the reported time period.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.Updated corrective action: an internal capa has been initiated to evaluate the sidewall pinch clamp and air in the sample bag.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 LRS PLATELET, PLT FILTER, AUTO PAS, PLASMA
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 9363541
• MDR Text Key: 177882181
• Report Number: 1722028-2019-00367
• 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: 11/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2020
• Device Catalogue Number: 82383
• Device Lot Number: 1808132130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2018
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 01/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other