MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA PLT SAMPLER, MULTIPLASMA RBC SET

Catalog Number	82408
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation: an unused tima set was returned to terumo bct 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 access portion of the inlet coil as detached and not returned with the set to aid in the investigation.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 or Problem Description
The customer reported that during the loading of the tubing set on the trima machine for an allogeneic platelet donation, they received air detected alarms and the sample bag inflated with air.Per the customer, all clamps were closed and no obvious holes were detected in the disposable tubing.There was no donor connected for this event, therefore no donor information is reasonably known at the time of the event.
Additional Manufacturer Narrative
This report is being filed to provide additional information.Corrected information is provided.Investigation: the run data file (rdf) was analyzed for this event.The rdf confirmed that the trima did alarm with 3 "pressure test error" alerts shortly after the set was loaded and the disposable test began.The screen text for these alerts does state: the system cannot maintain pressure.Verify: the white clamps on the donor line are closed.No air is in the sample bag.The pump headers are loaded correctly.The cassette is loaded correctly and there are no obstructions.The ref selected matches the tubing set loaded.The clamp on the crossover line is open.These ¿pressure test error¿ alerts were generated during the tubing set test in this procedure because the expected pressure increase was not seen in the allotted volume pumped.Based on the analysis of the rdf, it is suspected that the pressure increase was not sufficient because the pinch clamp on the sample bag line was likely not occluding the line properly.If the clamp on the sample bag line is not occluding the line properly during the tubing set test, air can have a pathway to enter the sample bag.The operator pressed ¿continue¿ to re-try the test after the first two alerts, however, after the third alert, the operator chose to unload the tubing set.The trima machine performed as intended.The operator chose to load a tubing set again (the run data file cannot tell whether this was the same tubing set or a new one).This time the tubing set test passed, however the operator chose to terminate the procedure prior to priming the set with ac.Corrected corrective action: an internal capa has been initiated to evaluate the sidewall pinch clamp and air in the sample bag.Investigation is in process.A follow-up report will be provided.
Additional Manufacturer Narrative
This report is being filed to provide updated information in g.1 and g.2.Investigation is in process.A follow-up report will be provided.
Additional Manufacturer Narrative
This report is being filed to provide additional information in corrective action: an internal capa has been initiated to evaluate air in the sample bag.Investigation is in process.A follow-up report will be provided.
Additional Manufacturer Narrative
This report is being filed to provide corrected information in corrected corrective action: an internal capa has been initiated to evaluate the sidewallpinch clamp.Investigation is in process.A follow-up report will be provided.
Additional Manufacturer Narrative
This report is being filed to provide additional information in h.6, h.7 and h.10.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
• Common Device Name: TRIMA PLT SAMPLER, MULTIPLASMA RBC SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 8879117
• Report Number: 1722028-2019-00222
• Device Sequence Number: 19469921
• Product Code: GKT
• UDI-Device Identifier: 05020583824089
• UDI-Public: 05020583824089
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: BK180231
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 08/09/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/01/2021
• Device Catalogue Number: 82408
• Device Lot Number: 1905301130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2019
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2019
• Supplement Date Received by Manufacturer: 09/25/2019; 10/08/2019; 11/04/2019; 12/04/2019; 12/27/2019
• Initial Report FDA Received Date: 08/09/2019
• Supplement Report FDA Received Date: 09/26/2019; 10/18/2019; 11/12/2019; 12/06/2019; 01/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other