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

Catalog Number 5805371

Device Problems Use of Device Problem (1670); Air/Gas in Device (4062)

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

Event Date 11/27/2021

Event Type  malfunction  

Event Description

The customer reported that during setup of the trima disposable, the alarm presser test failure occurred, and the customer 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

Investigation: terumobct (b)(4) 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.

Manufacturer Narrative

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.An unused trima set was returned for investigation.Visual inspection revealed no anomalies.The blood diversion bag was inspected, and a small amount of air was noted in the bag.The set was received with the pinch clamp on the tubing leading to the diversion bag closed.The clamp was opened to clear the air.The set was then loaded on the trima machine in the lab for pressure test.The set passed loading, 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.Additionally, no air was found in the diversion bag.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that during setup of the trima disposable, the alarm presser test failure occurred, and the customer 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

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 6 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 shows a close up of the cassette.The photo confirmed the set was assembled correctly with no evidence of kinks/flow restrictions.Photos 3 and 4 confirmed the needle line and sample line clamps were closed.Air was identified in the sample bag.Photos 5 and 6 show attempts to recreate the error by injecting air into the needle line in 2 scenarios: photo 5 where both the inlet and sample line clamps were closed (no air was introduced) and photo 6 where both the inlet and sample line clamps were open (air was introduced an unused trima set was returned for investigation.Visual inspection revealed no anomalies.The blood diversion bag was inspected, and a small amount of air was noted in the bag.The set was received with the pinch clamp on the tubing leading to the diversion bag closed.The clamp was opened to clear the air.The set was then loaded on the trima machine in the lab for pressure test.The set passed loading, 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.Additionally, 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.

Event Description

The customer reported that during setup of the trima disposable, the alarm presser test failure occurred, and the customer 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

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 6 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.Photo 2 shows a close up of the cassette.The photo confirmed the set was assembled correctly with no evidence of kinks/flow restrictions.Photos 3 and 4 confirmed the needle line and sample line clamps were closed.Air was identified in the sample bag.Photos 5 and 6 show attempts to recreate the error by injecting air into the needle line in 2 scenarios: photo 5 where both the inlet and sample line clamps were closed (no air was introduced) and photo 6 where both the inlet and sample line clamps were open (air was introduced an unused trima set was returned for investigation.Visual inspection revealed no anomalies.The blood diversion bag was inspected, and a small amount of air was noted in the bag.The set was received with the pinch clamp on the tubing leading to the diversion bag closed.The clamp was opened to clear the air.The set was then loaded on the trima machine in the lab for pressure test.The set passed loading, 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.Additionally, 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.The run data file (rdf) was analyzed for this event.Run data file analysis confirmed a ¿pressure test error¿ alert was generated twice during the tubing set test.Analysis showed both occurrences of this alert were generated because the access pressure sensor reading decreased more than expected after slight pump movement while the tubing set was positively pressurized.At the ¿pressure test error¿ alert screens, the operator was prompted to: ¿verify: the clamps on the donor line and sample bag line are closed.No air is in the sample bag.The pump headers are loaded correctly.The cassette is loaded correctly.There are no obstructions behind the cassette or cassette tray.The ref selected matches tubing set loaded¿ based on the analysis of the run data file, it is suspected that these ¿pressure test failure¿ alerts were generated because the pinch clamp on the sample bag line was likely not properly occluding the line.If the clamp on the sample bag line is not properly occluding the line during the tubing set test, air can have a pathway to enter the sample bag.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 declined by the customer.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that during setup of the trima disposable, the alarm presser test failure occurred, and the customer 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 that during setup of the trima disposable, the alarm presser test failure occurred, and the customer 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 h.6 and h.10.Corrected information provided 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 6 photographs of the disposable kit, summarized 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.Photo 2 shows a close up of the cassette.The photo confirmed the set was assembled correctly with no evidence of kinks/flow restrictions.Photos 3 and 4 confirmed the needle line and sample line clamps were closed.Air was identified in the sample bag.Photos 5 and 6 show attempts to recreate the error by injecting air into the needle line in 2 scenarios: photo 5 where both the inlet and sample line clamps were closed (no air was introduced) and photo 6 where both the inlet and sample line clamps were open (air was introduced an unused trima set was returned for investigation.Visual inspection revealed no anomalies.The blood diversion bag was inspected, and a small amount of air was noted in the bag.The set was received with the pinch clamp on the tubing leading to the diversion bag closed.The clamp was opened to clear the air.The set was then loaded on the trima machine in the lab for pressure test.The set passed loading, 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.Additionally, 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.The run data file (rdf) was analyzed for this event.Run data file analysis confirmed a ¿pressure test error¿ alert was generated twice during the tubing set test.Analysis showed both occurrences of this alert were generated because the access pressure sensor reading decreased more than expected after slight pump movement while the tubing set was positively pressurized.At the ¿pressure test error¿ alert screens, the operator was prompted to: ¿verify: the clamps on the donor line and sample bag line are closed.No air is in the sample bag.The pump headers are loaded correctly.The cassette is loaded correctly.There are no obstructions behind the cassette or cassette tray.The ref selected matches tubing set loaded¿ based on the analysis of the run data file, it is suspected that these ¿pressure test failure¿ alerts were generated because the pinch clamp on the sample bag line was likely not properly occluding the line.If the clamp on the sample bag line is not properly occluding the line during the tubing set test, air can have a pathway to enter the sample bag.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 declined by the customer.Root cause: a root cause assessment was performed for this complaint.Run data file analysis confirmed a ¿pressure test error¿ alert was generated twice during the tubing set test.Analysis showed both occurrences of this alert were generated because the access pressure sensor reading decreased more than expected after slight pump movement while the tubing set was positively pressurized.At the ¿pressure test error¿ alert screens, the operator was prompted to: ¿verify: the clamps on the donor line and sample bag line are closed.No air is in the sample bag.The pump headers are loaded correctly.The cassette is loaded correctly.There are no obstructions behind the cassette or cassette tray.The ref selected matches tubing set loaded¿ based on the analysis of the run data file, it is suspected that these ¿pressure test failure¿ alerts were generated because the pinch clamp on the sample bag line was likely not properly occluding the line.If the clamp on the sample bag line is not properly occluding the line during the tubing set test, air can have a pathway to enter the sample bag.In summary, 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: the 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: 13054125
• MDR Text Key: 287048787
• Report Number: 1722028-2021-00402
• 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: Nurse
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/21/2021

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: 05/01/2023
• Device Catalogue Number: 5805371
• Device Lot Number: 2105215151
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2021
• Initial Date FDA Received: 12/21/2021
• Supplement Dates Manufacturer Received: 04/14/2022; 04/14/2022; 04/14/2022; 04/14/2022
• Supplement Dates FDA Received: 01/14/2022; 03/04/2022; 03/29/2022; 04/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2021
• 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; Required Intervention