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

Catalog Number 5805371

Device Problems Use of Device Problem (1670); Protective Measures Problem (3015); Device Handling Problem (3265)

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

Event Date 06/13/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer description stated during setup, the alarm presser test failure occurred.The customer found the diversion bag was full with air.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 provided additional information in h.6, h.7 and h.10.Investigation: the customer description stated during setup, the alarm pressure test failure occurred.The customer found the diversion bag was full with air.The customer provided several photographs of the reported issue.The photos confirmed the presence of an inflated sample bag.The pinch clamps were identified on the correct lines and appeared to be closed adequately.The set did not contain blood which suggests it was not connected to the donor.No disposable defects could be identified from the photographs.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.Corrective action: an internal capa has been initiated to address pinch clamp not occluding the sample bag line consistently.Investigation is in process.A follow-up report will be provided.

Event Description

The customer description stated during setup, the alarm presser test failure occurred.The customer found the diversion bag was full with air.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: the customer description stated during setup, the alarm pressure test failure occurred.The customer found the diversion bag was full with air.The customer provided several photographs of the reported issue.The photos confirmed the presence of an inflated sample bag.The pinch clamps were identified on the correct lines and appeared to be closed adequately.The set did not contain blood which suggests it was not connected to the donor.No disposable defects could be identified from the photographs.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.An unused trima set was returned for investigation.The set was received with the blood diversion bag assembly detached from the kit at the 3-1 manifold.The assembly was received with the white pinch clamp on the blood diversion bag closed and the red and yellow pinch clamps open.Inspection revealed a small amount of air in the blood diversion bag.The white pinch clamp was confirmed functioning properly by fully occluding the tubing.The air in the blood diversion bag was not able to escape due to the closed white pinch clamp.The rest of the disposable set was visually evaluated for any mis-assembly, leak location, or defect that could have contributed to the reported incident with no anomalies observed.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.Corrective action: an internal capa has been initiated to address pinch clamp not occluding the sample bag line consistently.Investigation is in process.A follow-up report will be provided.

Event Description

The customer description stated during setup, the alarm presser test failure occurred.The customer found the diversion bag was full with air.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 description stated during setup, the alarm presser test failure occurred.The customer found the diversion bag was full with air.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: the customer description stated during setup, the alarm pressure test failure occurred.The customer found the diversion bag was full with air.Terumobct japan has confirmed the customer¿s statement and found the following: there was not anything wrong on the returned set.The customer provided several photographs of the reported issue.The photos confirmed the presence of an inflated sample bag.The pinch clamps were identified on the correct lines and appeared to be closed adequately.The set did not contain blood which suggests it was not connected to the donor.No disposable defects could be identified from the photographs.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.An unused trima set was returned for investigation.The set was received with the blood diversion bag assembly detached from the kit at the 3-1 manifold.The assembly was received with the white pinch clamp on the blood diversion bag closed and the red and yellow pinch clamps open.Inspection revealed a small amount of air in the blood diversion bag.The white pinch clamp was confirmed functioning properly by fully occluding the tubing.The air in the blood diversion bag was not able to escape due to the closed white pinch clamp.The rest of the disposable set was visually evaluated for any mis-assembly, leak location, or defect that could have contributed to the reported incident with no anomalies observed.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.Corrective action: an internal capa has been initiated to address pinch clamp not occluding the sample bag line consistently.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.

• 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 ; 3032314970
• MDR Report Key: 12180820
• MDR Text Key: 264051868
• Report Number: 1722028-2021-00236
• 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
• Report Date: 07/16/2021

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: 02/01/2023
• Device Catalogue Number: 5805371
• Device Lot Number: 2102054151
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/22/2021
• Initial Date FDA Received: 07/16/2021
• Supplement Dates Manufacturer Received: 07/26/2021; 11/10/2021; 01/27/2022
• Supplement Dates FDA Received: 08/10/2021; 11/12/2021; 02/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other