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

Model Number 82700

Device Problems Leak/Splash (1354); Increase in Pressure (1491); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/10/2020

Event Type  malfunction  

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 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.

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 Description

Full patient identifier: (b)(6) per the customer no air was returned to the donor.

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 Description

Per the customer, there were no adverse consequences to the donor.

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
• Type of Device: TRIMA ACCEL MULTIPLASMA, ISBT
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 10935874
• MDR Text Key: 220980010
• Report Number: 1722028-2020-00530
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583827004
• UDI-Public: 05020583827004
• Combination Product (y/n): N
• PMA/PMN Number: BK190332
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 11/10/2020
• Initial Date FDA Received: 12/02/2020
• Supplement Dates Manufacturer Received: 12/09/2020; 02/17/2021; 03/15/2021
• Supplement Dates FDA Received: 12/22/2020; 03/01/2021; 03/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 00064 YR
• Patient Weight: 132