MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA ACCEL ENHANCED PLATELET, PLASMA, RBC SET

Catalog Number 000000000000080440

Device Problem Device Expiration Issue (1216)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/04/2015

Event Type  malfunction  

Event Description

The customer reported that a patient who received a platelet transfusion collected on atrima system tested positive for coagulase negative staphylococcus epidermidis bacteria.During an experimental study, expired units (7 days) from platelet collections underwent bacterial testing.Two of the units tested positive for the bacteria.The patients who had received a platelet transfusion from the same two collections were then tested and found to have a positive bacterial result.Patient information is unavailable at this time.Patient outcome is unavailable at this time.The disposable set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Investigation: the customer provided the following donor information: (b)(6), who donates platelets bimonthly since 2012.Investigation is in process.A follow-up report will be provided.

Event Description

The patient information was not provided by the customer.The patient outcome was not provided by the customer.

Manufacturer Narrative

Investigation: the bacteria that was identified is eliminated in the sterilization process.The specific strain could not be confirmed as matching to what the transfusion recipient tested (b)(6) for.Per the customer, the donor has not had any issues in the past and is a bi-monthly, 12 gallon donor.The customer conducted an internal study and did not find a trend with respect to the operators.The disposable set that was used for the collection was requested but was not available.Additional information regarding the bacterial testing procedure, the customer's internal study of the operators, and information regarding the recipient were all requested but not received.The age of the transfused platelet product could not be confirmed.The run data files were analyzed and there were no abnormal signals or pause alarms that could potentially have contributed to bacterial contamination.The device history records (dhr) were reviewed for this lot.There were no issues noted in the dhr that would have contributed to this event.All quality labs and sterilization requirements passed.Root cause: although multiple requests were made, insufficient information was provided to definitively determine the cause of bacterial contamination.Possible causes for bacterial contamination platelet product and for the transfused patient include, but are not limited to,bacteria from the access venipuncture of the donor and improper tubing seal.

Manufacturer Narrative

This record was identified during a retrospective review of mdr's to identify records in which an event occurred, but the type of reportable event was not indicated appropriately in the mdr form.This supplement is being filed to modify information in and to align with the reported event.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL ENHANCED PLATELET, PLASMA, RBC SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: glenda o'neill ; 10810 w. collins ave; lakewood, CO 80215 ; 3032314051
• MDR Report Key: 4872427
• MDR Text Key: 5864173
• Report Number: 1722028-2015-00234
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK140180
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 000000000000080440
• Device Lot Number: 02Y4113
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/19/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 77