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

Catalog Number	80340
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/03/2019
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.Root cause: the definitive root cause of the leak from the plasma line seal safe weld cannot be conclusively determined.Possible causes of a leak from the weld include but are not limited to: operator using inadequate process to make and confirm the weld.Anomaly in the plasma line tubing that weakened the spot where the weld was made causing the weld to fail under pressure.
Event or Problem Description
The customer reported that an operator was using the seal safe on the trima machine post platelet collection to disconnect the plasma bag from the set.The seal that was created was reported as "poor" and broke, causing plasma to spray into the eyes of the operator.Immediately post exposure, the operator completed a 15 minute eye wash.The operator and the donors blood were tested post exposure and all results for (b)(6) were (b)(6).The platelet collection set is not available for return because it was discarded by the customer.

• Brand Name: TRIMA ACCEL
• Common Device Name: TRIMA ACCEL PLATELET SAMPLER MULTIPLASMA RBC SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 8469874
• Report Number: 1722028-2019-00075
• Device Sequence Number: 11208686
• Product Code: GKT
• UDI-Device Identifier: 05020583803404
• UDI-Public: 05020583803404
• 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
• Type of Report: Initial
• Report Date (Section B): 04/01/2019

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: 01/01/2021
• Device Catalogue Number: 80340
• Device Lot Number: 1901301130
• 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: 03/18/2019
• Initial Report FDA Received Date: 04/01/2019
• 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: 00027 YR
• Patient Weight: 84