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

Catalog Number 5805371

Device Problems Use of Device Problem (1670); Noise, Audible (3273)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/18/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported during setup, the operator heard noise from the return pump header and found air flowed into the diversion bag.No patient (donor) was connected at the time of the event, therefore, no patient information is available.Terumo bct is awaiting return of the disposable set for evaluation.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

The customer reported during setup, the operator heard noise from the return pump header and found air flowed into the diversion bag.No patient (donor) was connected at the time of the event, therefore, no patient information is available.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.

Manufacturer Narrative

This report is being filed to provide additional information in b.5, h.3, h.6 and h.10.Investigation: terumobct japan has confirmed the customer¿s statement and found the following: there was not anything wrong on the returned set.The possible root cause was unknown.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported during setup, the operator heard noise from the return pump header and found air flowed into the diversion bag.No patient (donor) was connected at the time of the event, therefore, no patient information is available.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.

Manufacturer Narrative

This report is being filed to provide additional information in e.3, h.6 and h.10 and corrected information in e.3.Investigation: terumobct japan has confirmed the customer¿s statement and found the following: there was not anything wrong on the returned set.The possible root cause was unknown.Terumobct japan provided 7 photographs of the disposable kit, summarised below: -photo 1 confirmed a complete trima set with no evidence of the presence of blood in the access needle, line or set.The sample diversion bag was verified inflated with air.-photos 2 and 3 confirmed the return pump header was assembled correctly with no evidence of kinks/flow restrictions.-photos 4 and 5 confirmed the needle line and sample line clamps were closed.Air was identified in the sample bag.-photos 6 and 7 show attempts to recreate the error by injecting air into the needle line in 2 scenarios: one where both the inlet and sample line clamps were closed and the other where the inlet clamp was open and the sample line closed.Lakewood: tbct japan returned the part for investigation.Visual inspection for kinks, occlusions, missing parts, mis-assembly or leaks which may have contributed to the reported incident did not reveal any abnormalities.It is noted that the set was received with the white pinch clamp on the diversion bag line closed and the yellow and red pinch clamps on the inlet line open.All pressure sensors were inspected and determined to be functioning properly.The set was loaded onto the trima machine in the lab with clamps in their "as found" position.Upon loading of the cassette and start of the pressure test, a pressure test error alarm occurred.The red pinch clamp was then closed and the continue button was pressed.The set passed the tubing set test and made it to the connect ac stage.The procedure was halted at this point and the set was unloaded.No alarms or errors were encountered.No air was found in the diversion bag.A disposable complaint history search was performed for this lot and found no reports for similar issues on this lot.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Corrective action: an internal capa has been initiated to address pinch clamp no occluding the sample bag line consistently.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.Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information in e.3, h.6 and h.10 and corrected information in e.3.Investigation: terumobct japan has confirmed the customer¿s statement and found the following: there was not anything wrong on the returned set.The possible root cause was unknown.Terumobct japan provided 7 photographs of the disposable kit, summarised below: -photo 1 confirmed a complete trima set with no evidence of the presence of blood in the access needle, line or set.The sample diversion bag was verified inflated with air.-photos 2 and 3 confirmed the return pump header was assembled correctly with no evidence of kinks/flow restrictions.-photos 4 and 5 confirmed the needle line and sample line clamps were closed.Air was identified in the sample bag.-photos 6 and 7 show attempts to recreate the error by injecting air into the needle line in 2 scenarios: one where both the inlet and sample line clamps were closed and the other where the inlet clamp was open and the sample line closed.Lakewood: tbct japan returned the part for investigation.Visual inspection for kinks, occlusions, missing parts, mis-assembly or leaks which may have contributed to the reported incident did not reveal any abnormalities.It is noted that the set was received with the white pinch clamp on the diversion bag line closed and the yellow and red pinch clamps on the inlet line open.All pressure sensors were inspected and determined to be functioning properly.The set was loaded onto the trima machine in the lab with clamps in their "as found" position.Upon loading of the cassette and start of the pressure test, a pressure test error alarm occurred.The red pinch clamp was then closed and the continue button was pressed.The set passed the tubing set test and made it to the connect ac stage.The procedure was halted at this point and the set was unloaded.No alarms or errors were encountered.No air was found in the diversion bag.A disposable complaint history search was performed for this lot and found no reports for similar issues on this lot.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Corrective action: an internal capa has been initiated to address pinch clamp no occluding the sample bag line consistently.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.Terumo bct has offered customer retraining for this issue.The regional quality assurance specialist confirmed that the retraining was rejected by the customer.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported during setup, the operator heard noise from the return pump header and found air flowed into the diversion bag.No patient (donor) was connected at the time of the event, therefore, no patient information is available.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

The customer reported during setup, the operator heard noise from the return pump header and found air flowed into the diversion bag.No patient (donor) was connected at the time of the event, therefore, no patient information is available.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.

Manufacturer Narrative

This report is being filed to provide additional information in e.1, h.6 and h.10 and corrected information in h.10.Investigation: terumobct japan has confirmed the customer¿s statement and found the following: there was not anything wrong on the returned set.The possible root cause was unknown.Terumobct japan provided 7 photographs of the disposable kit, summarised below: -photo 1 confirmed a complete trima set with no evidence of the presence of blood in the access needle, line or set.The sample diversion bag was verified inflated with air.-photos 2 and 3 confirmed the return pump header was assembled correctly with no evidence of kinks/flow restrictions.-photos 4 and 5 confirmed the needle line and sample line clamps were closed.Air was identified in the sample bag.-photos 6 and 7 show attempts to recreate the error by injecting air into the needle line in 2 scenarios: one where both the inlet and sample line clamps were closed and the other where the inlet clamp was open and the sample line closed.Lakewood: tbct japan returned the part for investigation.Visual inspection for kinks, occlusions, missing parts, mis-assembly or leaks which may have contributed to the reported incident did not reveal any abnormalities.It is noted that the set was received with the white pinch clamp on the diversion bag line closed and the yellow and red pinch clamps on the inlet line open.All pressure sensors were inspected and determined to be functioning properly.The set was loaded onto the trima machine in the lab with clamps in their "as found" position.Upon loading of the cassette and start of the pressure test, a pressure test error alarm occurred.The red pinch clamp was then closed and the continue button was pressed.The set passed the tubing set test and made it to the connect ac stage.The procedure was halted at this point and the set was unloaded.No alarms or errors were encountered.No air was found in the diversion bag.A disposable complaint history search was performed for this lot and found no reports for similar issues on this lot.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.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.Terumo bct has offered customer retraining for this issue.The regional quality assurance specialist confirmed that the retraining was rejected by the customer.Root cause: a root cause assessment was performed for this complaint.Based on the available information a definitive root cause is believed to 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.Corrected corrective action: this internal capa has been initiated to address pinch clamp no occluding the sample bag line consistently is no longer applicable to this event.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL PLASMA SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer (Section G): TERUMO BCT; 10810 w. collins ave; lakewood CO 80215
• Manufacturer Contact: scot hilden ; 10810 w. collins ave; lakewood, CO 80215
• MDR Report Key: 13259909
• MDR Text Key: 286049966
• Report Number: 1722028-2022-00023
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2023
• Device Catalogue Number: 5805371
• Device Lot Number: 2107025151
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2021
• 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