MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA ACCEL MULTIPLASMA, ISBT

Model Number	82700
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation: a used trima access/draw line was returned for investigation.Visual inspection revealed a leak at the ac line bond socket of the 3-1 manifold of the access/draw line.The leak is as a result of a bonding leak path inside the bond socket.Investigation is in process.A follow-up report will be provided.
Event or Problem Description
The customer reported that during a plasmapheresis procedure they found that the set was defective.During plasma collection, they received a centrifuge pressure high alarm and the customer followed prompts on trima to assess possible issues.The customer found that there was air being pulled into the lines just above the manifold where the single tubing from the donor to the manifold connect.There was also blood dripping from this same place.The collection was discontinued without rinseback.A diagram from customer indicated the leak was at the 3-1 manifold.Per the customer no serious injury occured and no medical intervention was required for this event.Patient information and outcome are not available at this time.
Additional Manufacturer Narrative
This report is being filed to provide additional information in a.1, a.2, a.3, a.4 and b.5.Investigation is in process.A follow-up report will be provided.
Event or Problem Description
Full patient identifier: (b)(6) per the customer no air was returned to the donor.
Additional Manufacturer Narrative
This report is being filed to provide additional information in b.5, h.6 and h.10 investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.A disposable complaint history search for lot 2009112130 found no other reports of a similar failure.Investigation is in process.A follow up report will be provided.
Event or Problem Description
Per the customer, there were no adverse consequences to the donor.
Additional Manufacturer Narrative
This report is being filed to provide additional information in h.6 and h.10.Root cause : the infusion of air into the 3:1 manifold occurred due to the leak.A definitive root cause for the leak could not be determined.Possible causes include but are not limited to: - inadequate contact tubing with a bond socket after solvent application - insufficient application of solvent to the tubing - inadequate insertion of tubing into the bond socket correction: terumo bct has implemented a correction for this incident.Manufacturing staff were made aware of this issue and retrained to the appropriate procedures.

• Brand Name: TRIMA ACCEL
• Common Device Name: TRIMA ACCEL MULTIPLASMA, ISBT
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 10935874
• Report Number: 1722028-2020-00530
• Device Sequence Number: 11555934
• Product Code: GKT
• UDI-Device Identifier: 05020583827004
• UDI-Public: 05020583827004
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 12/02/2020

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2020
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2020
• Supplement Date Received by Manufacturer: 12/09/2020; 02/17/2021; 03/15/2021
• Initial Report FDA Received Date: 12/02/2020
• Supplement Report FDA Received Date: 12/22/2020; 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: 00064 YR
• Patient Weight: 132