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

Catalog Number	80360
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	09/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation: a used trima set, containing blood, was returned for investigation.It is noted that blood has circulated throughout the set.Additionally, the donor needle was not returned to aid in the investigation.The disposable set was visually evaluated for any mis assembly, leak location, or defect that could have contributed to the reported incident.A blood clot in the filter of the return reservoir was confirmed.All pressure sensors were inspected and determined to be functioning properly.Hemostats and gravity were used to manipulate fluid throughout the set and no fluid flow or line obstruction issues were noted.All witness and wear marks indicate individual loop and channel components were properly loaded.Per the trima accel procedure summary (taps), terumo bct clinical specialist confirmed that the first return cycle had been completed.The procedure was ended due to the multiple draw pressure too low alerts and the clots they observed in the reservoir.The reports also confirmed that the duration of run was 6 minutes and a total of 39 ml of ac was used.The operator selected a double platelet collection at 2:12 pm and immediately received numerous draw pressure too low alarms (21x).The run was terminated without rinse-back.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Root cause: a definitive root cause could not be determined.Possible causes include butare not limited to:- ac line from the top of the cassette to the ac bag was pinched behind the cassette plate- ac line from the bottom of the cassette to the inlet manifold was pinched by the armrest of the bed- improper anti-coagulation of the extracorporeal system- the donor's physiology.
Event or Problem Description
The customer reported that during a trima collection procedure, they noticed clots in there turn reservoir, and when the operator removed the needle, there was a clot at the venipuncture site.The clot at the needle was discovered when they removed the needle from the donor's arm.Per the customer, the donor was ok and healthy.He had no problems during or postprocedure.The complete patient id is (b)(6).

• Brand Name: TRIMA ACCEL
• Common Device Name: TRIMA ACCEL ENHANCED PLATELET,PLASMA,RBC,AUTO RBC SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 7913221
• Report Number: 1722028-2018-00263
• Device Sequence Number: 19396908
• Product Code: GKT
• UDI-Device Identifier: 05020583803602
• UDI-Public: 05020583803602
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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
• Report Date (Section B): 09/27/2018

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: 07/01/2020
• Device Catalogue Number: 80360
• Device Lot Number: 1807243230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2018
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2018
• Initial Report FDA Received Date: 09/27/2018
• 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
• Patient Age: 73 YR
• Patient Weight: 89