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

Catalog Number	80350
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.The run data file (rdf) was analyzed for this event.Root cause: the signals in the run data file indicate that the higher-than-expected wbc content in the platelet product was likely a result of an escape of wbcs from the lrs chamber during a portion of the procedure.It cannot be ruled out that the high number of adjustments made in the middle of the procedure disrupted the steady-state of the system and contributed to the elevated wbc content measured in the platelet product.It also cannot be ruled out that the higher-than- expected wbc content in the platelet product could be donor-related.
Event or Problem Description
The customer requested the run data file be investigated to determine a possible cause for the higher-than-expected wbc content in the platelet product.The patient's unit id (b)(6).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.The trima collection set was not returned as it was discarded by the customer.(due to system limitations, the 1 lb.Entered into the patient weight in the report could not be deleted once it was inadvertently added.).

• Brand Name: TRIMA ACCEL
• Common Device Name: TRIMA ACCEL PLATELET, PLASMA, RBC, AUTO RAS SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 7924485
• Report Number: 1722028-2018-00270
• Device Sequence Number: 13821314
• Product Code: GKT
• UDI-Device Identifier: 05020583803503
• UDI-Public: 05020583803503
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: BK170157
• 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

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: Other
• Device Expiration Date: 06/01/2020
• Device Catalogue Number: 80350
• Device Lot Number: 1806142230
• 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: 09/08/2018
• Initial Report FDA Received Date: 10/01/2018
• 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