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

Catalog Number 5805371

Device Problems Device Difficult to Setup or Prepare (1487); Use of Device Problem (1670)

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

Event Date 07/11/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation: terumobct (b)(4) has confirmed the customer¿s statement and found the following: there were no issues with 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 that during setup they received an alarm.The customer checked the set and tried to reinstall.However, the alarm occurred again, and the customer found that the sampling bag was filled with air.There was no patient connected during set up, therefore, no patient information is reasonably known and the donor was safe.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

Corrected information in b.3.Investigation: terumobct japan has confirmed the customer¿s statement and found the following: there were no issues with the returned set.The possible root cause was unknown.The customer returned the disposable set to tbct japan for investigation.The blood diversion bag appeared to be inflated with air with the red and white clamps closed, and the yellow clamp open.Both red and white clamps were in closed position and the yellow clamp was open.Air was expressed from the blood diversion bag, and the red clamp was opened with the white pinch clamp remaining closed.Air was then injected via the inlet line, and it was confirmed that the white clamp performed as intended by not allowing air to enter the blood diversion bag.Air was again introduced via the inlet line with the red clamp closed and the white clamp opened, and it was confirmed that the red clamp performed as intended by not allowing air to enter the blood diversion bag.Air was again introduced via the inlet line with both red and white clamps opened, and it was confirmed that air was able to enter the blood diversion pouch.Terumo bct japan returned the set to terumo bct lakewood for further review.An unused trima sample bag assembly attached to the access line assembly was returned for investigation.The assembly was visually inspected for any mis-assembly, leak location, or defect that could have contributed to the reported incident with no anomalies observed.Clamps on the assembly were tested for proper function with and air source.30 psi air was applied to the assembly and pinch clamp function was confirmed.No air moved passed the clamps into the sample bag.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 evaluate the air in the sample bag.Correction: the regional specialist confirmed with sales that the customer was notified with regards to the cause of the incident for retraining purposes.Formal retraining was rejected by the customer since the notification was considered sufficient for future prevention.A disposable complaint history search was performed for this lot and found no reports for similar issues on this lot worldwide.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that during setup they received an alarm.The customer checked the set and tried to reinstall.However, the alarm occurred again, and the customer found that the sampling bag was filled with air.There was no patient connected during set up, therefore, no patient information is reasonably known and the donor was safe.The run data file (rdf) was analyzed for this event.Run data file analysis showed a ¿pressure test error¿ alert was generated following the first kit load at the start of the tubing set test while the system verified that the donor line and sample bag line clamps were closed as prompted.This ¿pressure test error¿ alert was generated because the expected pressure change was not observed at the access pressure sensor during the clamp closure verification.In response to this alert, the operator chose to unload the tubing set.At the second tubing set load, a ¿pressure test error¿ alert was generated during the tubing set test.Analysis showed this alert was generated because the access pressure sensor reading decreased more than expected after slight pump movement while the tubing set was positively pressurized.At both ¿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.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 they received an alarm.The customer checked the set and tried to reinstall.However, the alarm occurred again, and the customer found that the sampling bag was filled with air.There was no patient connected during set up, therefore, no patient information is reasonably known and the donor was safe.The run data file (rdf) was analyzed for this event.Run data file analysis showed a ¿pressure test error¿ alert was generated following the first kit load at the start of the tubing set test while the system verified that the donor line and sample bag line clamps were closed as prompted.This ¿pressure test error¿ alert was generated because the expected pressure change was not observed at the access pressure sensor during the clamp closure verification.In response to this alert, the operator chose to unload the tubing set.At the second tubing set load, a ¿pressure test error¿ alert was generated during the tubing set test.Analysis showed this alert was generated because the access pressure sensor reading decreased more than expected after slight pump movement while the tubing set was positively pressurized.At both ¿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.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 were no issues with the returned set.The possible root cause was unknown.The customer returned the disposable set to tbct japan for investigation.The blood diversion bag appeared to be inflated with air with the red and white clamps closed, and the yellow clamp open.Both red and white clamps were in closed position and the yellow clamp was open.Air was expressed from the blood diversion bag, and the red clamp was opened with the white pinch clamp remaining closed.Air was then injected via the inlet line, and it was confirmed that the white clamp performed as intended by not allowing air to enter the blood diversion bag.Air was again introduced via the inlet line with the red clamp closed and the white clamp opened, and it was confirmed that the red clamp performed as intended by not allowing air to enter the blood diversion bag.Air was again introduced via the inlet line with both red and white clamps opened, and it was confirmed that air was able to enter the blood diversion pouch.Terumo bct japan returned the set to terumo bct lakewood for further review.An unused trima sample bag assembly attached to the access line assembly was returned for investigation.The assembly was visually inspected for any mis-assembly, leak location, or defect that could have contributed to the reported incident with no anomalies observed.Clamps on the assembly were tested for proper function with and air source.30 psi air was applied to the assembly and pinch clamp function was confirmed.No air moved passed the clamps into the sample bag.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 evaluate the air in the sample bag.Correction: the regional specialist confirmed with sales that the customer was notified with regards to the cause of the incident for retraining purposes.Formal retraining was rejected by the customer since the notification was considered sufficient for future prevention.A disposable complaint history search was performed for this lot and found no reports for similar issues on this lot worldwide.Root cause: based on the analysis of the run data file and the part evaluation of the returned kit, it is confirmed that these ¿pressure test failure¿ alerts were generated because the pinch clamp on the sample bag line was 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.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL PLASMA SET,JAPANESE
• 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: 12269354
• MDR Text Key: 266846389
• Report Number: 1722028-2021-00255
• 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
• Report Date: 08/03/2021

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: 03/01/2023
• Device Catalogue Number: 5805371
• Device Lot Number: 2103094151
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/12/2021
• Initial Date FDA Received: 08/03/2021
• Supplement Dates Manufacturer Received: 12/03/2021; 12/21/2021
• Supplement Dates FDA Received: 12/20/2021; 01/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2021
• 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