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

Catalog Number 10220

Device Problems Air Leak (1008); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 05/28/2018

Event Type  malfunction  

Manufacturer Narrative

Lot number, manufacture date and expiry date are not available at this time.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that during a spectra optia exchange procedure, the registered nurse(rn) visualized small bubbles that were not moving in the blood warmer line.The blood warmer was disconnected and the procedure was continued.Per the customer, no air was returned to the donor and the procedure was successfully completed.The patient is reported in stable condition.Patient information is not available at this time.The exchange set is not available for return because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provide additional information and corrected information.Investigation is in process.A follow-up report will be provided.

Event Description

Customer declined to provide patient identifier.

Manufacturer Narrative

This report is being filed to provide additional information.Investigation: the disposable set was not available for return.The device history record (dhr) was reviewed for this event.There were no issues noted in the dhr that would have contributed to the air in the line as experienced by the customer.Per the customer, very small bubbles had formed in the blood warmer line.No other air was reported in the set.The customer stated that none of these bubbles were returned to the patient and no air was returned to the patient.The customer removed the blood warmer tubing when the air bubbles were noted and subsequently continued the procedure successfully without further incident.In addition, no leak was observed by the customer that would indicate a potential loose luer connection to the blood warmer tubing.Per the customer, the procedure was completed successfully with no alarms, including no return line air detector alarms indicating air that could potentially be returned to the patient.No air was observed in the set aside from the bubbles seen in the blood warmer tubing.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.After the blood warmer tubing (which contained the reported air bubbles) was disconnected, no further air was reported by the customer and the procedure was subsequently completed successfully.Outgassing is a known phenomenon that occurs.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
• Manufacturer Contact: steve kern ; 10810 w. collins ave.; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 7629878
• MDR Text Key: 112469837
• Report Number: 1722028-2018-00181
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153601
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2020
• Device Catalogue Number: 10220
• Device Lot Number: 1803013130
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 11/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 00048 YR
• Patient Weight: 52