MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; KIT,SEAL SAFE INSTALL

Model Number 71251

Device Problems Leak/Splash (1354); Adverse Event Without Identified Device or Use Problem (2993); Protective Measures Problem (3015)

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

Event Date 08/19/2019

Event Type  Injury  

Manufacturer Narrative

Investigation: per the customer, they switched the sealer head with a known working sealer head and found that the sealer still did not make complete seals.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that an operator experienced a blood exposure to the eye while using the seal safe on the trima machine post platelet collection.Per the operator, the seal safe did not seal the tubing properly and while separating the platelet bag tubing after sealing the tube,resulting in platelets spraying in the operator's eye.The operator performed the eye wash immediately after the exposure and operator's blood was drawn for a blood exposure kit per customer's internal policy.Per customer the operator is back to work with her normal schedule.The customer declined to provide the operator's identifier (id).

Manufacturer Narrative

Since the replacement of the sealer head has resolved the issue, it is likely that this part was defective or a contributing factor to the faulty seal on the platelet tubing.The specific root cause of the blood exposure could not be determined.Possible causes include, but are not limited to: - a lack of/or inadequate personal protective equipment - a failure to follow exposure control processes.

Event Description

After multiple attempts, the customer did not provide additional procedural details, includingfinal blood test results.

Manufacturer Narrative

This report is being filed to provide in investigation: on 08/26/2019, the service representative shipped a sealer head to thecustomer for replacement.The device serial number history report indicates no further related issues have been reported forthis device.Per the trima operator's manual, instructions for use section: due to possible exposure to thehepatitis virus, the human immunodeficiency virus, and other infectious agents in the handling ofextracorporeal blood circuits, it is recommended that operators take adequate precautions at alltimes to prevent exposure to, and transmission of, such agents.One year of service history was reviewed for this device with no issues related to the reportedcondition identified.Investigation is in process, a follow-up report will be provided.

Manufacturer Narrative

This report is being filed to provide updated information in g.1 and g.2.Investigation is in process.A follow up report will be provided.

• Brand Name: TRIMA ACCEL
• Type of Device: KIT,SEAL SAFE INSTALL
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 9033629
• MDR Text Key: 165074554
• Report Number: 1722028-2019-00262
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• PMA/PMN Number: BK040069
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71251
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 08/20/2019
• Initial Date FDA Received: 09/13/2019
• Supplement Dates Manufacturer Received: 10/15/2019; 10/15/2019; 12/26/2019
• Supplement Dates FDA Received: 10/08/2019; 11/01/2019; 12/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 00027 YR
• Patient Weight: 68