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

Model Number 82446

Device Problems Contamination /Decontamination Problem (2895); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Patient Involvement (2645)

Event Date 05/02/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation: the customer reported that there were 2 units collected on the same machine, using the same disposable lot number that tested postiive for bacterial contamination.The customer questioned if there were any other similar reports, due to the common factors in the incidents.The terumo bct specialist informed her there were no similar reports and that contamination could be related to lab testing technique, donor arm prep, or the disposable.The other incident reported by the customer is provided in mdr # 1722028-2020-00257.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that they had a platelet unit test positive for bacterial contamination during lab qc.The unit is in quarantine and was not transfused.Bact testing done but the exact test results are unknown at this time.Donor unit #: (b)(6) the bacterial contamination was detected in the lab.The unit was not transfused, therefore there is no patient information reasonably known.The disposable set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Investigation: a disposable history search for this lost found no reports of similar failures worldwide.The device history record was reviewed for this lot.There were no issues noted that would have contributed to the bacterial contamination.Per internal sterilization 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

Bacterial test results were not provided by the customer.The bacterial contamination was detected in the lab.The unit was not transfused, therefore there is no patient information reasonably known.Donor information is provided in section a.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL LRS PLATELET SAMPLER PLASMA RBC SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 10097477
• MDR Text Key: 209223621
• Report Number: 1722028-2020-00256
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583824461
• UDI-Public: 05020583824461
• Combination Product (y/n): N
• PMA/PMN Number: BK190332
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 05/28/2020

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: 03/01/2022
• Device Model Number: 82446
• Device Catalogue Number: 82446
• Device Lot Number: 2003061130
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 05/06/2020
• Initial Date FDA Received: 05/28/2020
• Supplement Dates Manufacturer Received: 07/08/2020
• Supplement Dates FDA Received: 07/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 00063 YR
• Patient Weight: 120