MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA ACCEL LRS PLT SAMPLER PLASMA RBC SET

Catalog Number 82440

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

Patient Problem No Patient Involvement (2645)

Event Date 07/21/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation: an unused trima set was returned to terumo bct for evaluation.The disposable set was visually evaluated for any mis- assembly, leak location, or defect that could have contributed to the reported incident and no anomalies were observed.The clamps on the inlet coil were in the closed position upon receipt.All pressure sensors were inspected and determined to be functioning properly.The set was loaded onto the trima device in the laboratory and all onscreen prompts for clamping were followed.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.The investigator is unable to determine if the disposable set contributed to the reported alarm.Based on the evidence found, the root cause of the reported failure was due to a clamping error.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Investigation is in-process.A follow-up report will be provided.

Event Description

The customer reported air in the sample bag prior to phlebotomy of the donor.Per the customer, pre-phlebotomy, the disposable set failed the pressure test and they noticed that the sample bag was filled with air.It was reported that they tried the pressure test twice and failed each time.There was not a transfusion recipient or patient involved at the time of this incident as the reported issue was detected prior to starting the procedure, therefore no patient/recipient information is reported for the event.

Manufacturer Narrative

Investigation: per the run data file (rdf) for this event, alarm 61 shut down the procedure because it could not tell the clamp was closed.In that case, it checked if the clamp was closed, did not see the appropriate delta (first alert), then checked again after they continued and still did not see the pressure delta and failed, ending the procedure.If is possible that the customer could have loaded the same set the next attempted procedure, got another pressure test failure, unloaded, then loaded another set.The system cannot determine if it was the same set loaded or different for this event.Corrected corrective action: an internal capa was initiated to evaluate the sidewall pinch clamp not effectively occluding the sample bag line consistently and air in the sample bag.Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information and updated information in investigation: the system prompted the operator to verify that the white clamps on thedonor line were closed and that there was no air in the sample bag.Investigation is in process.A follow-up report will be reported.

Manufacturer Narrative

This report is being filed to provide updated investigation: an unused trima set was returned to terumo bct for evaluation.The disposable set was visually evaluated for any mis-assembly, leak location, or defect that couldhave contributed to the reported incident.The sidewall clamp on the sample bag line had damageto one of the sidewalls.Additionally, the clamps on the inlet coil were in the closed position uponreceipt.All pressure sensors were inspected and determined to be functioning properly.The setwas loaded onto the trima machine in the lab and all on screen prompts for clamping werefollowed.The set passed loading, tubing set test and made it to the connect ac stage.Theprocedure was halted at this point and the set was unloaded.No alarms or errors wereencountered.Correction: an internal capa has been initiated to evaluate air in the sample bag.Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

This report is being filed to provide in corrected corrective action: an internal capa was initiated to evaluate the sidewall pinch clamp not effectively occluding the sample bag line consistently.Investigation is in process, a follow-up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional and updated information in e.3, h.6, h.7 and h.10.Updated investigation: an unused trima set was returned to terumo for investigation.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.The clamps on the inlet coil were in the closed position upon receipt.All pressure sensors were inspected and determined to be functioning properly.The set was loaded onto the trima machine in the lab and all on screen prompts for clamping were followed.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.Tbct investigation was unable to determine if the disposable set contributed to the reported alarm.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.Root cause: specific root cause could not be definitively determined for this incident.Possible causes include: a clamp malfunction where the clamp skews to the side as it is closed, or 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.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL LRS PLT SAMPLER PLASMA RBC SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 8901331
• MDR Text Key: 165023259
• Report Number: 1722028-2019-00231
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583824409
• UDI-Public: 05020583824409
• Combination Product (y/n): N
• PMA/PMN Number: K181049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2021
• Device Catalogue Number: 82440
• Device Lot Number: 1904044151
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2019
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 12/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other