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 Consequences Or Impact To Patient (2199)

Event Date 05/20/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation: per the customer, there was no clotting in the channel or the return reservoir.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported seeing air in the return line during a red blood cell exchange (rbcx) procedure on a sickle cell patient.Air bubbles were seen in the entirety of the blood warmer tubing leading all the way to the needle.The tubing from the blood warmer was removed and the procedure was completed.The procedure was tolerated well by the patient.Patient identifier is not available at this time.Terumo bct is awaiting return of the disposable set.

Manufacturer Narrative

Investigation: the device history record was reviewed for this lot.There were no issues noted that would have contributed to this incident.The customer returned the used astotube blood warmer 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 3-40 mm in length interspersed periodically throughout the blood in the tubing.No leaks, kinks/occlusions or manufacturing defects were identified.Investigation is in process.A follow up report will be provided.

Event Description

Patient id was not provided.Pursuant to european data protection laws, the patient id is not available from the customer.

Manufacturer Narrative

This report is being filed to provide additional information in a.1 and h10.Investigation: the run data file (rdf) was analyzed for this event.Per review of the rdf, 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.It is also possible that the bubbles are the result of a small, unidentified luer leak at the blood warmer via a loose luer connection that was hung 50 cm or higher above the return access.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 10143417
• MDR Text Key: 199448300
• Report Number: 1722028-2020-00289
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• PMA/PMN Number: K183081
• 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: 06/11/2020

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: 05/20/2020
• Initial Date FDA Received: 06/11/2020
• Supplement Dates Manufacturer Received: 07/09/2020; 08/26/2020
• Supplement Dates FDA Received: 07/23/2020; 09/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ASTOTUBE (IFT 40410)
• Patient Outcome(s): Other
• Patient Age: 00042 YR
• Patient Weight: 86