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

Catalog Number 10220

Device Problems Device Operational Issue (2914); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 11/22/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation: the run data file (rdf) was analyzed for this event.Signals in the rdf confirmed that the spectra optia device operated as intended.The customer provided two photographs of the rbcx exchange set for investigation.Upon photographic inspection, it was observed that the tiny air bubbles were clinging to the sides of the blood warmer tubing.There does not appear to be a leak in the blood warmer tubing set.Root cause: common causes of the ¿low level reservoir sensor detected air¿ alarm are foamy blood in the reservoir or vibration that causes sloshing of the blood in the reservoir.The operator continued from this alarm and had no further reservoir sensor alarms for the remainder of the run.The signals from the return line air detector (rlad) did not show any presence or accumulationor air during the procedure.

Event Description

The customer reported that during a red blood cell exchange (rbcx) procedure, they observed air bubbles in the return line and blood warmer tubing line.Bubbles were seen in the blood warmer tubing and at a certain point in the procedure the bubbles moved towards the patient.The patient is reported in 'stable' condition.Patient identifier (id) is not available at this time.The rbcx set is not available for return because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provide additional information.Additional investigation: the customer did not provide the lot number pertaining to this event, therefore a device history record (dhr) search could not be conducted for this specific incident.All lots must meet acceptance criteria before release.Upon photographic inspection, small air bubbles were observed in the blood warmer tubing line.Updated root cause: common causes of the ¿low level reservoir sensor detected air¿ alarm are foamy blood in the reservoir or vibration that causes sloshing of the blood in the reservoir.The operator continued from this alarm and had no further reservoir sensor alarms for the remainder of the run.The signals from the return line air detector did not show any presence or accumulation of air in the return line.The spectra optia system operated as intended.The return line air detector was detecting fluid in the return line for the entire rbcx procedure.Based on the information available in the run data file there is no indication of a clear root cause for the air observed in the blood warmer tubing.The operator initially had the luer connection at the very top of the blood warmer in the front of the tube holder.This was later corrected by attaching another blood warmer tubing with the luer connection positioned lower than the front of the tubing holder.The pictures provided by the customer confirmed that the luer connection between the return line and the blood warmer tubing was tight and there was no indication of a leak.They also confirmed that the position of the luer connection was not 20 inches higher than the return line.Based on all the evidence, it is likely that the small air bubbles in the return line were caused by out-gassing of the red blood cell units due to the use of a blood warmer.

Event Description

The customer did not respond to multiple attempts to obtain patient identifier and lot information.

Manufacturer Narrative

Additional investigation: per terumo bct's internal risk documentation, outgassing of cold replacement fluids can occur when the fluids are warmed through the blood warmer intpe and rbcx procedures.When blood warmer tubing is connected to the return line, any air bubbles could be infused into the patient.Based on the calculation of the maximum rate of air generated in animal models, a low level health hazard risk from outgassing in the reported case is expected.The absence of reported clinical symptoms when outgassing has been noted and supports this contention.Updated root cause: common causes of the ¿low level reservoir sensor detected air¿ alarm are foamy blood in the reservoir or vibration that causes sloshing of the blood in the reservoir.The operator continued from this alarm and had no further reservoir sensor alarms for the remainder of the procedure.The signals from the return line air detector did not show any presence or accumulation of air in the return line.The spectra optia system operated as intended and is safe to use.The return line air detector was detecting fluid in the return line for the entire rbcx procedure.Based on the information available in the run data file there is no indication of a clear root cause for the air observed in the blood warmer tubing.The operator initially had the luer connection at the very top of the blood warmer in the front of the tube holder.This was later corrected by attaching another blood warmer tubing with the luer connection positioned lower than the front of the tubing holder.The photographs provided by the customer confirmed that the luer connection between the return line and the blood warmer tubing was tight and there was no indication of a leak.They also confirmed that the position of the luer connection was not 20 inches higher than the return line.During the rbcx procedure 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 usually 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

Additional investigation: air drawn into the system would have been detected in the centrifuge and relocated to the reservoir.No alarms in the rdf analysis suggested that air was drawn into the system from inlet to last point of detection.

Manufacturer Narrative

Updated investigation: the customer provided two pictures to aid in the investigation.The pictures show tiny air bubbles clinging to the sides of the blood warmer tubing.The pictures confirmed that the luer connection between the return line and the blood warmer tubing was tight and there was no indication of a leak.The pictures also confirmed that the position of the luer connection was not 20 inches higher than the return line.Air drawn into the system would have been detected in the centrifuge and relocated to the reservoir.Per the rdf, no alarms suggested air was drawn into the system from inlet to last point of detection.Updated root cause: root cause of the air bubbles in the blood warmer tubing is due to continuous outgassing of the cold replacement fluid.The signals from the return line air detector did not show any presence or accumulation of air in the return line.The return line air detector was detecting fluid in the return line for the entire red blood cell exchange (rbcx) procedure.During an rbcx 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 usually 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.Based on the information provided by the customer confirming the proper connection of the return luer to the blood warmer, and the absence of air as evidenced by the run data analysis, the root cause of the air bubbles in the blood warmer tubing was caused by continuous outgassing of the cold replacement fluid.

• 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: 7122380
• MDR Text Key: 95904418
• Report Number: 1722028-2017-00487
• 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,Followup,Followup
• Report Date: 12/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 10220
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 09/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Weight: 64