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 07/18/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation: per the customer, the temperature of heating was 39 ° c.The customer returned one used optia set for investigation.Visual inspection confirmed the set was assembled correctly with no kinks, leaks, occlusions or missing parts.Flow of blood was observed throughout the set and in the inlet line, cassette and channel.Foam was present in the return reservoir and the vent bag was mildly inflated.The patient return lines were saturated with fluid however the blood warmer tubing appeared interspersed with air bubbles, measuring approximately between 1-10mm in length.No disposable manufacturing defects were identified.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Investigation is in process.A follow up report will be provided.

Event Description

The customer reported air bubbles in the tubing during an apheresis procedure on a spectra optia device.The bubbles were reported as in the tubing at the level of the heater, there were no bubbles between the connection luer-lock and blood tubing warmer.Per the customer the bubbles were about 0.5 mm in size and were mobile.Per the customer there was no observed consequence to the patient, however, per the customer a significant amount of bubbles were formed, creating a risk of air embolism in the patient.Patient age and weight are not available at this time.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 updated information for the root cause: the root cause of the air bubbles noted in blood warmer tubing was due to outgassing.No other air was noted in the set and no leaks were observed during procedure.The customer stated that the blood warmer temperature was set too high which was creating the micro bubbles in the blood warmer tubing.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.

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.

Manufacturer Narrative

This report is being filed to provide additional information in investigation: the customer was able to make the necessary adjustment to the temperatureof their blood warmer.Customer reported that since the adjustment there have been noproblems with the appearance of bubbles.Root cause: the root cause of the air bubbles noted in blood warmer tubing was due tooutgassing.No other air was noted in the set and no leaks were observed during procedure.The customer stated that the blood warmer temperature was set too high which was creatingthe micro bubbles in the blood warmer tubing.

Event Description

Due to eu personal data protection laws, the patient age and weight are not available from thecustomer.No medical intervention was required for this event.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 8888722
• MDR Text Key: 165022437
• Report Number: 1722028-2019-00229
• 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,Followup
• Report Date: 08/13/2019

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: 12/01/2020
• Device Catalogue Number: 10225
• Device Lot Number: 1812103230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2019
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 07/19/2019
• Initial Date FDA Received: 08/13/2019
• Supplement Dates Manufacturer Received: 09/25/2019; 10/15/2019; 10/30/2019
• Supplement Dates FDA Received: 09/26/2019; 10/18/2019; 10/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other