MAUDE Adverse Event Report: TERUMO BCT SPECTRA OPTIA; SPECTRA OPTIA EXCHANGE SET

Catalog Number 10225

Device Problems Gas/Air Leak (2946); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 02/06/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation is in process.A follow up report will be provided.

Event Description

The customer reported that one hour into the apheresis procedure, they noticed air bubbles in the blood warmer tubing line.They decided to remove the blood warmer, then finish the procedure without the blood warmer.Patient information and outcome are unavailable at this time.The disposable set is not available for return because it was discarded by the customer.This product is not available within the us, but this report is being filed due to an alleged failure that could occur on a similarly marketed device platform cleared for use by the fda.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.10.Investigation: the device history record (dhr) was reviewed for this lot.There were no issues noted in the dhr that would have contributed to air in the blood warmer tubing.Root cause: the root cause of the air bubbles noted in blood warmer tubing was due to outgassing.During exchange procedures on spectra optia, the replacement fluids may be cold.If they are not allowed to warm to room temperature, and if the return blood is warmed, air bubbles may form.The reason for this "outgassing" is that gasses are more soluble in liquids at low temperatures than at higher temperatures.If at a low storage temperature air is available to dissolve in a fluid and approaches its equilibrium solubility at that temperature, when the fluid is warmed the air will come out of solution, because its solubility is exceeded at the higher temperature.It is typically described as chains of very small bubbles or foam, which tend to rise toward the top of the tubing.The small bubbles may coalesce to form larger bubbles.

Event Description

Pursuant to eu privacy protection laws, the patient information/outcome are not available from the customer.The customer declined to provide further information for this event, including additional procedural and patient details.

Manufacturer Narrative

This report is being filed to provide additional information in d.2, b.5 and h.10.Investigation: dates for the respective procedures were not provided, therefore a data log analysis could not be performed.Investigation is in process.A follow up report will be provided.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 9796541
• MDR Text Key: 185292934
• Report Number: 1722028-2020-00087
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• 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: 03/05/2020

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: 09/01/2021
• Device Catalogue Number: 10225
• Device Lot Number: 1909233230
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 02/12/2020
• Initial Date FDA Received: 03/06/2020
• Supplement Dates Manufacturer Received: 05/19/2020; 06/23/2020
• Supplement Dates FDA Received: 06/08/2020; 06/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other