MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA LRS PLATELET PLASMA RBC AUTOPAS SET

Model Number 82410

Device Problems Fluid/Blood Leak (1250); Microbial Contamination of Device (2303); Device Misassembled During Manufacturing /Shipping (2912); Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 11/25/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation: the customer submitted one photograph in lieu of the disposable set to aid investigation.The image shows the bottom of the primary platelet bag containing platelets, the spike port, a section of the platelet product sampler line tubing and a section of the platelet collect line tubing with blue slide clamp.The customer has indicated the location of the leak by circling the platelet collect line tubing port and where it enters the bag vinyl.A leak is identified at the port where the vinyl is rf welded.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported they observed a leak in the platelet bag from a trima collection set.The incubation resulted in a positive culture for anaerobic bacteria.The disposable set is not available for return because it was discarded by the customer.There was not a transfusion recipient or patient involved at the time of testing, therefore no patient information is reasonably known at the time of the event.

Manufacturer Narrative

This report is being filed to provide additional information in b.5 and h.10.Investigation: the customer did not provide the serial number for the trima device used for the collection procedure.No abnormal events were reported and the customer stated no system alarms occurred during the run.A disposable complaint history search for lot 2008031130 found no other reports of leaks or bacterial contamination.Per internal sterility documentation, the devices terumo bct manufactures to collect, separate, and store blood products are terminally sterilized to a sterility assurance level (sal) of

Event Description

Bact/alert sn and bact/alert sa testing was performed with a positive result.The media was incubated for 7 days in a bactalert 3d 60 bacteriological analyzer.The incubation resulted in a positive culture for anaerobic bacteria.The product was discarded.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.10.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: the microbial contamination was caused by the leak at the port where the vinyl sheets were not completely rf welded.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA LRS PLATELET PLASMA RBC AUTOPAS SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 11436387
• MDR Text Key: 243103608
• Report Number: 1722028-2021-00098
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583824102
• UDI-Public: 05020583824102
• Combination Product (y/n): N
• PMA/PMN Number: BK190332
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/08/2021

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: 08/01/2022
• Device Model Number: 82410
• Device Catalogue Number: 82410
• Device Lot Number: 2008031130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2021
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 02/14/2021
• Initial Date FDA Received: 03/08/2021
• Supplement Dates Manufacturer Received: 03/10/2021; 04/14/2021
• Supplement Dates FDA Received: 03/30/2021; 04/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other