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

Model Number	82700
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation: the run data file (rdf) was analyzed for this event.Taps and rdf show that there were two centrifuge pressure high alerts during plasma collection (one at the beginning, one at the end).Trima displayed notification to verify the plasma volume due to the cps high alerts.Signals in the level sensors following the first cps alert indicate that a possible occlusion or pump header misload may have contributed to the alert and cannot be ruled out for contributing to the higher than expected plasma volume.Regardless, trima did display verify plasma volume messages due to the alerts during the procedure.Investigation is in process.A follow-up report will be provided.
Event or Problem Description
The customer reported that following an apheresis plasma collection on the trima device, the collection measured 937ml, which was over the limit for this collection and more plasma volume was collected than expected.They had more than one person verify the weight, conversion, and tares to ensure it was done appropriately.Predicted volume was 825 ml.Measured volume was 937ml.Tbv is 5389 x 15% tbv = 808.35 ml - 109 ac = 709 ml total volume collected.Full patient (donor) identifier: (b)(6).Patient age is not available at this time.The donor experienced no adverse effects from this procedure.The disposable set is not available for return because it was discarded by the customer.
Additional Manufacturer Narrative
This report is being filed to provide additional information in h.6 and h.10.Investigation: the disposable lot query was performed for lot 2009112130 and no similar reported occurrences were received against this lot to date.Root cause: a definitive root cause of the excessive plasma collection could not be determined.Possible causes include but are not limited to: occlusion due to pump header misload or an unidentified manufacturing error.Plasma pump misload preventing tubing occlusion.Inaccurate pumping due to stack-up of pump tolerances.
Additional Manufacturer Narrative
This report is being filed to provide additional information in h6 and h10.Investigation :the predicted volume was 825 ml and the measured volume was 937 l, a 13.6% difference.Analysis of the taps report and run data file found there were two centrifuge pressure high alerts during the plasma collection (one at the beginning, one at the end).The trima displayed notification to verify the plasma volume due to the cps high alerts.Signals in the level sensors following the first cps alert indicate that a possible occlusion or pump header misload may have contributed to the alert and cannot be ruled out for contributing to the higher than expected plasma volume.Regardless, the trima did display verify plasma volume messages due to the alerts during the procedure.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Investigation is in process.A follow-up report will be provided.
Additional Manufacturer Narrative
This report is being filed to provide additional information in a.2 and h.10.Investigation: total plasma collected: 937 ml - 123 ml (ac in plasma bag) = 814 ml, which is greater than 15% tbv (5389 ml x 15% tbv = 808.35 ml).Investigation is in process.A follow up report will be provided.

• Brand Name: TRIMA ACCEL
• Common Device Name: TRIMA ACCEL MULTIPLASMA SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 10809358
• Report Number: 1722028-2020-00499
• Device Sequence Number: 19470121
• Product Code: GKT
• UDI-Device Identifier: 05020583827004
• UDI-Public: 05020583827004
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: BK190332
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/09/2020

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: 09/01/2022
• Device Model Number: 82700
• Device Catalogue Number: 82700
• Device Lot Number: 2009112130
• 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: 10/16/2020
• Supplement Date Received by Manufacturer: 12/30/2020; 02/19/2021; 03/08/2021
• Initial Report FDA Received Date: 11/09/2020
• Supplement Report FDA Received Date: 01/14/2021; 03/01/2021; 03/23/2021
• 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: 62 YR
• Patient Weight: 79