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 07/03/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation: per the customer, the joints were all well sealed.One used asto tube blood warming tubing set containing blood was returned to terumo bct for investigation.Upon visual inspection, the presence of microbubbles throughout the tubing length was confirmed.No leaks or other defects were identified.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that at approximately the end of a red blood cell exchange (rbcx)apheresis procedure during the return cycle, the operator noticed air bubbles in the bloodwarmer tubing that was connected to the return line.Per the operator, the patient was disconnected and is doing 'well' without the presence of any clinical symptoms post-procedure.The patient identifier 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.

Manufacturer Narrative

This report is being filed to provide in investigation: a review of the device history record (dhr) for this unit showed no irregularitiesduring manufacturing that were relevant to this issue.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 thecustomer.No medical intervention was required for this event.

Manufacturer Narrative

This report is being filed to provide updated information and additional information.Corrected information is provided in b.3.Investigation: per the customer, there was no clotting in the channel or return reservoir.Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

This report is being filed to provide in 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.During exchange procedures on spectra optia, the replacement fluids may be cold.If they arenot allowed to warm to room temperature, and if the return blood is warmed, air bubbles mayform.The reason for this "outgassing" is that gasses are more soluble in liquids at lowtemperatures than at higher temperatures.If at a low storage temperature air is available todissolve in a fluid and approaches its equilibrium solubility at that temperature, when the fluid iswarmed the air will come out of solution, because its solubility is exceeded at the highertemperature.It is typically described as chains of very small bubbles or foam, which tend to risetoward 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: 8833212
• MDR Text Key: 164813672
• Report Number: 1722028-2019-00202
• 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: 07/26/2019

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: 03/01/2021
• Device Catalogue Number: 10225
• Device Lot Number: 1903153130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2019
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 07/04/2019
• Initial Date FDA Received: 07/26/2019
• Supplement Dates Manufacturer Received: 08/02/2019; 09/16/2019; 10/15/2019
• Supplement Dates FDA Received: 08/20/2019; 10/08/2019; 10/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ASTO TUBE WARMING : IFT40410 / (B)(4)
• Patient Outcome(s): Other
• Patient Age: 00037 YR
• Patient Weight: 57