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 Known Impact Or Consequence To Patient (2692)

Event Date 02/05/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation: one used and one unused astotube blood warming tubing was returned to terumo bct for evaluation.The used astotube had an extra piece of tubing connected which contained a shut off valve.The luer end connected to the optia return line was rf sealed and removed.Visual inspection of the used tubing confirmed there was small pockets of air interspersed throughout the tubing.Per the customer, the blood warmer was regulated/set to 37°c.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that one hour into an apheresis procedure, they noted bubbles in the blood warmer tubing.Per the customer, the bubbles were observed where the patient had been injected.They decided to remove blood warmer and then finished the procedure without the warmer and no further issues occured.Per the customer, no serious injury occured and no medical intervention was required for the event.Patient information is 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.

Event Description

During follow-up with the customer, it was reported that the type of procedure was erythrocyte exchange and there were no alarms occured during the run for air and the sample bag was not inflated.There was medical consultation done for this event by a physician a the customer site.There was no air being drawn in through the ac filter and there was no clotting in the channel or reservoir.

Manufacturer Narrative

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

Event Description

Due to eu personal data protection laws, the patient identifier is not available from the customer.

Manufacturer Narrative

Investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.The run data file (rdf) was analyzed for this event.Review of the relevant dlog confirmed the rbc exchange was completed successfully with only one alarm ("return pressure was too" high alarm.No "air in the return tubing" alarm(s) were generated, 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.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 9769870
• MDR Text Key: 185697961
• Report Number: 1722028-2020-00086
• 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: 02/28/2020

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2020
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 02/06/2020
• Initial Date FDA Received: 02/28/2020
• Supplement Dates Manufacturer Received: 05/26/2020; 09/28/2020
• Supplement Dates FDA Received: 05/29/2020; 09/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BLOOD WARMER: ASTOTUBE (IFT 40410), BATCH 32415108.
• Patient Outcome(s): Other
• Patient Age: 00042 YR
• Patient Weight: 78