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

Catalog Number 10225

Device Problems Obstruction of Flow (2423); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/29/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation: the customer returned the used astotube blood warming tubing, connected to a short section of optia return line and catheter tubing for investigation.The customer did not return the spectra optia set with the tubing.Visual inspection confirmed the presence of sections of air, measuring between approximately 3-30 mm in length interspersed periodically throughout the blood in the tubing.No leaks, kinks/occlusions or manufacturing defects were identified.All luer connections were verified to be all tight.Investigation is in process.A follow up report will be provided.

Event Description

The customer reported microbubbles in the return tubing during a red blood cell exchange procedure on a spectra optia device.The tubing was on a blood warmer at 37°, according to protocol.Rinseback was not performed at the end of the procedure.There were no consequences to the patient.Due to eu personal data protection laws, the patient identifier is not available from 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: per review of dlog, the rbcx procedure was completed successfully with no return-line air detector (rlad) alarms indicating that air in the blood warmer tubing was generated downstream of the rlad, which is consistent with outgassing of blood.Root cause: based on the investigation, the root cause of the air bubbles noted in blood warmer tubing may be related 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.Returned part evaluation confirmed that the luer connection was secure.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.10.Investigation: the device history record was reviewed for this lot.There were no issues noted that would have contributed to the air bubbles seen by the customer.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: 10302399
• MDR Text Key: 200609095
• Report Number: 1722028-2020-00343
• 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: 07/21/2020

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: 01/01/2022
• Device Catalogue Number: 10225
• Device Lot Number: 2001283330
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2020
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 06/30/2020
• Initial Date FDA Received: 07/21/2020
• Supplement Dates Manufacturer Received: 07/22/2020; 08/26/2020
• Supplement Dates FDA Received: 08/13/2020; 09/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 68