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

Model Number	82300
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Lot number and expiry are not available at this time.Investigation is in process.A follow up report will be provided.
Event or Problem Description
The customer reported an occlusion and air bubbles during a platelet collection.It is unknown at this time the location of the air bubbles or if air was returned to the donor.Patient (donor) information and outcome are not available at this time.The platelet collection set is not available for return because it was discarded by the customer.
Additional Manufacturer Narrative
Investigation: the dlogs were unavailable for this event.The customer provided information about a similar incident (1722028-2020-00363).The dlog for the similar incident indicated "possible air block" because at 21 minutes into the procedure, after receiving an alarm for low platelet concentration, the operator performed an air block recovery.It is possible, however not conclusive, the customer received a similar verification flag for this procedure.The customer did not respond to requests to provide the lot number for the disposable; therefore, a dhr search could not be conducted for this specific incident.All lots must meet acceptance criteria for release.Root cause: a definitive root cause could not be determined.Possible causes for air bubbles include but are not limited to: an occlusion in the disposable set due to manufacturing error, including solvent or molding occlusions; incomplete loading of the disposable set causing an occlusion in the tubing and/or an air block, which restricted the flow.Introduction of air into the anti-coagulant (ac), saline or inlet line during or after disposable prime (if prime solution bag runs dry and air from the bag is pulled into the tubing); a kink or an occlusion in the collect line.
Event or Problem Description
Due to eu personal data protection laws, the patient information is not available from the customer.

• Brand Name: TRIMA ACCEL
• Common Device Name: TRIMA ACCEL LRS PLATELET, PLASMA SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: scot hilden ; 10810 w collins ave; lakewood, CO 80215 ; 3032314970
• MDR Report Key: 10379116
• Report Number: 1722028-2020-00368
• Device Sequence Number: 2793459
• Product Code: GKT
• UDI-Device Identifier: 05020583823006
• UDI-Public: 05020583823006
• Combination Product (Y/N): N
• PMA/510(K) Number: BK190332
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2020

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 Model Number: 82300
• Device Catalogue Number: 82300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2020
• Supplement Date Received by Manufacturer: 06/15/2022
• Initial Report FDA Received Date: 08/07/2020
• Supplement Report FDA Received Date: 06/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown