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

Model Number 82700

Device Problems Fluid/Blood Leak (1250); Misassembled (1398)

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

Event Date 11/18/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that during a collection they observed leaking at the manifold where the saline line enters the manifold.It is unkown at this time if air was returned to the paitent/donor.Per the customer there was no injury or medical intervention for this event.Full patient id: (b)(6).Patient age, sex, and weight are not available at this time.No blood exposure occurred as a result of the ser leak.Terumo bct is awaiting return of the disposable set.

Manufacturer Narrative

This report is being filed to provide additional information in d.9, h.6 and h.10.Investigation: a used trima set containing blood was returned for investigation.It was noted that blood had circulated throughout the set.Visual inspection revealed evidence of a leak in the ac tubing on the inlet coil at the bond to the 3-1 manifold.Further inspection revealed a leak path in the ac tubing bond to the manifold bond socket.Investigation is in process.A follow up report will be provided.

Manufacturer Narrative

Investigation: the tubing appears to have been inserted to specification.A small amount of air, estimated at around approximately 1ml, was observed within the 3:1 manifold.Investigation is in process.A follow up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.10.Investigation: a disposable complaint history search for lot 2009142130 found no other reports of a similar failure.Correction: terumo bct has implemented a correction for this incident.Manufacturing staff were made aware of this issue and retrained to the appropriate procedures.Root cause: a definitive root cause for the reported leak could not be determined.Possible causes include but are not limited to: - inadequate contact of the tubing with the bond socket after solvent application - insufficient application of solvent to the tubing a root cause for the infusion of air into the 3:1 manifold component is believed to be related to the occurrence of a leak.

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.Investigation is in process.A follow up report will be provided.

Event Description

The customer declined to provide patient (donor) age, sex, or weight.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL MULTIPLASMA SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 10976747
• MDR Text Key: 242862959
• Report Number: 1722028-2020-00541
• 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,Followup
• Report Date: 12/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2020
• 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: 2009142130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2020
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 03/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 00061 YR
• Patient Weight: 98