MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; ACCEL PLT,PLASMA,ISBT

Model Number 80300

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 09/26/2021

Event Type  malfunction  

Event Description

The customer reported the sample bag inflated during the disposable set test.The operator checked the clamp was closed.No patient (donor) was connected at the time of the event, therefore, no patient information is available.The platelet collection is not available for return because it was discarded by the customer.

Manufacturer Narrative

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

Manufacturer Narrative

This report is being filed to provide additional information in e.1, h.6 and h.10.Investigation: the customer provided a video file of the reported event.The video indicated an inflated sample bag during the tube set test.It was not possible to confirm if the access line clamp was closed.The sample bag pinch clamp appeared to be closed, but it was not possible to determine if the clamp was closed adequately, or indeed if there was a clamp defect.There was no blood in the set and no donor was connected.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.A disposable complaint history search was performed for this lot and found no reports for similar issues on this lot.Corrective action: an internal capa has been initiated to evaluate the sidewall pinch clamp and air in 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.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported the sample bag inflated during the disposable set test.The operator checked the clamp was closed.No patient (donor) was connected at the time of the event, therefore, no patient information is available.The platelet collection is not available for return because it was discarded by the customer.

Event Description

The customer reported the sample bag inflated during the disposable set test.The operator checked the clamp was closed.No patient (donor) was connected at the time of the event, therefore, no patient information is available.The platelet collection is not available for return because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provide additional information in b6, h6 and h10.Investigation: the customer provided a video file of the reported event.The video indicated an inflated sample bag during the tube set test.It was not possible to confirm if the access line clamp was closed.The sample bag pinch clamp appeared to be closed, but it was not possible to determine if the clamp was closed adequately, or indeed if there was a clamp defect.There was no blood in the set and no donor was connected.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.A disposable complaint history search was performed for this lot and found no reports for similar issues on this lot.The run data file (rdf) was analyzed for this event.Run data file analysis showed the pause button was pressed during the positive pressure test.Review of the aps signal during the positive pressure test is consistent with the possibility the white clamp on the sample bag line was not fully occluding the sample bag line when closed, leaving a small pathway for air to enter the sample bag.Run data file analysis showed the pause button was pressed during the positive pressure test, before a ¿pressure test error¿ alert was generated.Corrective action: an internal capa has been initiated to evaluate the sidewall pinch clamp and air in 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.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 and h.10.Corrected information is provided in h.7 and h.10.Investigation: the customer provided a video file of the reported event.The video indicated an inflated sample bag during the tube set test.It was not possible to confirm if the access line clamp was closed.The sample bag pinch clamp appeared to be closed, but it was not possible to determine if the clamp was closed adequately, or indeed if there was a clamp defect.There was no blood in the set and no donor was connected.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.A disposable complaint history search was performed for this lot and found no reports for similar issues on this lot.The run data file (rdf) was analyzed for this event.Run data file analysis showed the pause button was pressed during the positive pressure test.Review of the aps signal during the positive pressure test is consistent with the possibility the white clamp on the sample bag line was not fully occluding the sample bag line when closed, leaving a small pathway for air to enter the sample bag.Run data file analysis showed the pause button was pressed during the positive pressure test, before a ¿pressure test error¿ alert was generated.Corrected correction: trima field action 35 is no longer applicable to this event.Corrective action: an internal capa has been initiated to evaluate the sidewall pinch clamp and air in the sample bag.Root cause: a root cause assessment was performed for this complaint.Based on the available information a definitive root cause could not be determined but it is likely due to one or a combination of the possible causes listed below: * a clamp malfunction where the clamp skews to the side as it is closed * 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

The customer reported the sample bag inflated during the disposable set test.The operator checked the clamp was closed.No patient (donor) was connected at the time of the event, therefore, no patient information is available.The platelet collection is not available for return because it was discarded by the customer.

• Brand Name: TRIMA ACCEL
• Type of Device: ACCEL PLT,PLASMA,ISBT
• 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: 12692735
• MDR Text Key: 280532040
• Report Number: 1722028-2021-00339
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583803008
• UDI-Public: 05020583803008
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: BK190332
• 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
• Report Date: 10/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2022
• Device Model Number: 80300
• Device Catalogue Number: 5803001
• Device Lot Number: 2011034251
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/03/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/02/2020
• 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