MAUDE Adverse Event Report: TERUMO BCT SPECTRA OPTIA; SPECTRA OPTIA APHERESIS SYSTEM

Model Number 61000

Device Problems Improper Flow or Infusion (2954); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 10/21/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation: a terumo bct service technician checked out the machine at the customer site to check the ac pump and ac ratio and was unable to duplicate the reported condition.A simulated run was perfromed and it was verified that no air was in the set while running.No issues were found.Investigation is in process.A follow-up report will be provided.

Event Description

The customer contacted terumo bct customer support to request service for an optia device.Per the customer, they were seeing the fluid in the drip chamber getting lower than expected on the blood warmer tubing used and more air was entering the drip chamber.The customer was concerned that the ac ratio was not functioning as it should.Terumo bct customer support advised the customer to check the connections when they connect the optia tubing to the blood warmer as this can cause air to enter the system, as well as ensure that the connection is no higher than 20 inches from the return access.The customer informed support it was not.Patient information and outcome are not available at this time.

Manufacturer Narrative

This report is being filed to provide additional information in a.1, a.2, a.3, a.4, h6 & h10.Investigation: the device serial number history report indicates no further related issues have been reported for this device.A disposable complaint history search for lot 2007293130 found no other reports for this failure type worldwide.One year of service history was reviewed for this device with no issues related to the reported condition identified.The device history record for lot 2007293130 was reviewed.There were no issues noted in the dhr.All quality labs and sterilization passed.Investigation is in process.A follow up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information in b.5, b.7, h.6, and h.10 and corrected information in b.3 and e.3.Root cause: the root cause of the reported extra air in the blood warmer drip chamber could not be determined.It's possible that there was air in the return line prior to patient connection and/or the air was being drawn into the return line/blood warmer connection, which was captured in the chamber due to: - an insufficient connection between the return line and blood warmer tubing resulting from damage, an unidentified manufacturing error, or a failure to completely connect the luers - an intermittent software error or operator failure to completely prime the return line.

Event Description

The operator indicated that 'the air was only in the drip chamber.When i started i had the drip chamber ¾ way full and a few hours later there was barely anything in the drip chamber'.She confirmed that there was no clotting, no medical intervention and no return line air detector (rlad) alarms.Per the customer, the patient is transplanted and doing well.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA APHERESIS SYSTEM
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 11637436
• MDR Text Key: 247284023
• Report Number: 1722028-2021-00146
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583610002
• UDI-Public: 05020583610002
• Combination Product (y/n): N
• PMA/PMN Number: BK140151
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/08/2021

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?: No
• Device Operator: Health Professional
• Device Model Number: 61000
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 03/09/2021
• Initial Date FDA Received: 04/08/2021
• Supplement Dates Manufacturer Received: 05/18/2021; 06/17/2021
• Supplement Dates FDA Received: 05/24/2021; 07/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 00024 YR
• Patient Weight: 50