MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA PLATELET+SAMPLER MULTIPLS RBC SET

Model Number	80400
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Date of Event	04/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Lot number and expiry information are not available at this time.Investigation: (pmcf protocol cts-5083) investigation is in process.A follow-up report will be provided.
Event or Problem Description
The customer reported during a clinical study they had a positive test for bacterial contamination of bacillus species in a collected unit.It is unknown at this time if the unit was transfused to a patient.Donor unit #: (b)(6).The disposable set is not available for return because it was discarded by the customer.
Additional Manufacturer Narrative
Investigation: the disposable set was not available for return.A disposable history search for this lot found no reports of failures.The customer reported that the culture was positive for bacillus species.Per literature review of bacillus species - infectious disease and antimicrobial therapy by (b)(6) m.D., m.P.H., bacillus organisms are widely distributed in the environment although the primary habitat is the soil.These organisms are usually found in decaying organic matter, dust, vegetable, water, and some species are part of the normal flora.In the clinical setting, outbreaks and pseudo epidemic have been traced to contaminated ventilator equipment, disinfectant (ethyl alcohol), hospital linen and dialysis equipment.Per internal documentation, the devices terumo bct manufactures to collect, separate, and store blood products are terminally sterilized to a sterility assurance level (sal) of
Event or Problem Description
Per the customer, the product was discarded.There was not a transfusion recipient or patient involved at the time of this incident, therefore no patient information is reasonably known at the time of the event.

• Brand Name: TRIMA ACCEL
• Common Device Name: TRIMA PLATELET+SAMPLER MULTIPLS RBC SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 10051637
• Report Number: 1722028-2020-00234
• Device Sequence Number: 3881570
• Product Code: GKT
• UDI-Device Identifier: 05020583804005
• UDI-Public: 05020583804005
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2020

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: 02/01/2021
• Device Model Number: 80400
• Device Catalogue Number: 80340
• Device Lot Number: 1902051130
• 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: 04/20/2020
• Supplement Date Received by Manufacturer: 06/25/2020
• Initial Report FDA Received Date: 05/13/2020
• Supplement Report FDA Received Date: 06/29/2020
• 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