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

Catalog Number 12220

Device Problems Infusion or Flow Problem (2964); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/30/2020

Event Type  malfunction  

Manufacturer Narrative

Lot number and expiry information are not available at this time.Investigation: terumo bct clinical support advised the customer to make sure the luer connection at the blood warmer was secure and no more than 20 in from the patient connection.Clinical support also asked about the temperature of the replacement products.The customer did not provide further details.The customer did indicate that the leur connections were tight and there was no clotting in the channel or return reservoir and there were no alarms for air during the procedure.Per the staff at the customer site, there may have been a time during treatment where patient was lowered to lowest position on bed, potentially resulting in it being a bigger gap than 20 inches.Following the procedure, a staff member at the customer site that is tech trained on the optia tested the machine.The staff technician confirmed that everything passed, including the air detector.Per the staff technician, based on terumo bct¿s technical test, the machine itself seems to be operating correctly.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported seeing air bubbles in the blood warmer tubing attached to the optia device during a red blood cell exchange (rbcx) procedure.They didn't believe the patient had received any air and it was reported that the nurse was at the bedside watching the return line to make sure the patient didn't receive any air.No medical intervention was required for this event.Per the customer, the nurse was emptying air in line before it got to patient via aspiration with needle and syringe or detaching the blood warmer tubing from the patient connection and letting the blood go into a trash can.After a certain point air just sat in warmer lines and no longer moved towards patient and the procedure was continued.The patient is reported as "fine".The customer declined to provide patient information.The disposable set is not available for return because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provide additional information in d.4, h.4, h.6 and h.10.Investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Root cause: the root cause of the air bubbles noted in blood warmer tubing was due 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: 10083581
• MDR Text Key: 199542458
• Report Number: 1722028-2020-00246
• 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
• Report Date: 05/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2020
• 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: 12220
• Device Lot Number: 2001173230
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 06/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other