MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA ACCEL LRS PLATELET, PLASMA, RBC SET

Model Number	80406
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow up report will be provided.
Event or Problem Description
The customer reported that during process of the disposable set on the trima device the operator left the sample bag clamp open and the pressure test failed.The customer received the alarm "pressure test error".Patient information and outcome are not available at this time.The disposable set is not available for return because it was discarded by the customer.
Additional Manufacturer Narrative
This report is being filed to provide additional information in a.2, a.3, a.4, b.5, h.6 and h.10 investigation: further evaluation of this event has determined that the device did not cause or contribute to a death or serious injury, nor is there a likely potential for death or serious injuryassociated with this event based on additional investigational information.The customer clarified that there was no air in the sample bag and no pressure test alarm occurred.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
Upon follow up, the customer clarified the event.They stated that no air was seen at all.When they started the procedure, they directed the first part of the blood to the sample bag, afterwards, they opened the blue clamp but did not close the white clamp to the sample bag.Alarm 32819 occurred.The sample bag was full of blood.Customer declined to provide patient identifier.
Additional Manufacturer Narrative
This report is being filed to provide additional information in h.10.Investigation: the customer confirmed they received alarm 32819.The alarm is generated prior to first return when the system believes it has pumped a first cycle volume greater than the upper volume limit and the upper level sensor has not yet detected fluid.Correction: the relevant operator has been retrained to ensure the white pinch clamp on the sample bag tubing line is properly closed once the sample bag contains the desired volume.Investigation is in process.A follow up report will be provided.
Additional Manufacturer Narrative
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 and h.10.Root cause:the root cause for the reported "first cycle error" alarm was due to the operator failing to close the white pinch clamp on the sample bag tubing line after sample collection.

• Brand Name: TRIMA ACCEL
• Common Device Name: TRIMA ACCEL LRS PLATELET, PLASMA, RBC SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 10536068
• Report Number: 1722028-2020-00446
• Device Sequence Number: 2948786
• Product Code: GKT
• UDI-Device Identifier: 05020583804067
• UDI-Public: 05020583804067
• Combination Product (Y/N): N
• PMA/510(K) Number: BK190332
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 09/15/2020

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: 10/01/2021
• Device Model Number: 80406
• Device Catalogue Number: 80406
• Device Lot Number: 1910181130
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2020
• Supplement Date Received by Manufacturer: 10/06/2020; 11/02/2020; 11/23/2020; 01/25/2021
• Initial Report FDA Received Date: 09/15/2020
• Supplement Report FDA Received Date: 10/09/2020; 11/02/2020; 11/23/2020; 01/28/2021
• 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
• Patient Age: 00045 YR
• Patient Weight: 83