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

Model Number 12220

Device Problems Gas/Air Leak (2946); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/07/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported that during a red cell exchange (rbcx) procedure approximately 20 mins from completion time, air was noted in return blood warmer tubing without clear rationale.The procedure was stopped.Per the customer, there was no clinical harm to the patient.Patient information is not available at this time.The disposables set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Investigation: the run data file (rdf) was analyzed for this event.Review of the rdf and aim images does not show a conclusive cause of the reported air in the return line by the customer.There were no signs of air entering the kit and no return line air detector alarms.It is also possible that the blood warmer tubing was not connected properly potentially causing a leak.The machine is safe to use.If air is seen in the return line by the operator the best course of action is to initiate the air removal sequence.When connecting a blood warmer tubing set to the return line, ensure that the tubing connection is tight.Put the luer connection no higher than 20 in (50 cm) above the return access to prevent the possibility of air entering the tubing.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that during a red cell exchange (rbcx) procedure approximately 20 mins from completion time, air was noted in return blood warmer tubing without clear rationale.The procedure was stopped.Per the customer, there was no clinical harm to the patient.Patient identifier and age are not available at this time.Patient weight and gender were obtained from rdf.The disposables 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 h.6 and h.10.Investigation: the run data file (rdf) was analyzed for this event.Review of the rdf and aim images does not show a conclusive cause of the reported air in the return line by the customer.There were no signs of air entering the kit and no return line air detector alarms.It is also possible that the blood warmer tubing was not connected properly potentially causing a leak.The machine is safe to use.If air is seen in the return line by the operator the best course of action is to initiate the air removal sequence.When connecting a blood warmer tubing set to the return line, ensure that the tubing connection is tight.Put the luer connection no higher than 20 in (50 cm) above the return access to prevent the possibility of air entering the tubing.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.A disposable complaint history search was performed for this lot and found no reports for similar issues on this lot worldwide.Root cause: review of the dlog and aim images does not show a conclusive cause of the reported air in the return line by the customer.There were no signs of air entering the kit and no return line air detector alarms.It is also possible that the blood warmer tubing was not connected properly potentially causing a leak.The machine is safe to use.If air is seen in the return line by the operator the best course of action is to initiate the air removal sequence.When connecting a blood warmer tubing set to the return line, ensure that the tubing connection is tight.Put the luer connection no higher than 20 in (50 cm) above the return access to prevent the possibility of air entering the tubing.Another possible root cause for air bubbles in the blood warmer tubing was due to outgassing of cold replacement fluids.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.Additionally, a disposable defect cannot be ruled out that could cause the low level sensor to report fluid instead of air resulting in air pumping towards patient, an occlusion in the return filter causing a vacuum between the filter and the return pump header resulting in degassing the blood, or a poor connection to blood warmer due to excess solvent at the luer causing air to enter return line for a small patient.

Event Description

The customer reported that during a red cell exchange (rbcx) procedure approximately 20 mins from completion time, air was noted in return blood warmer tubing without clear rationale.The procedure was stopped.Per the customer, there was no clinical harm to the patient.Patient identifier and age are not available at this time.Patient weight and gender were obtained from rdf.The disposables 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 h.6 and h.10.Investigation: the run data file (rdf) was analyzed for this event.Review of the rdf and aim images does not show a conclusive cause of the reported air in the return line by the customer.There were no signs of air entering the kit and no return line air detector alarms.It is also possible that the blood warmer tubing was not connected properly potentially causing a leak.The machine is safe to use.If air is seen in the return line by the operator the best course of action is to initiate the air removal sequence.When connecting a blood warmer tubing set to the return line, ensure that the tubing connection is tight.Put the luer connection no higher than 20 in (50 cm) above the return access to prevent the possibility of air entering the tubing.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.A disposable complaint history search was performed for this lot and found no reports for similar issues on this lot worldwide.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that during a red cell exchange (rbcx) procedure approximately 20 mins from completion time, air was noted in return blood warmer tubing without clear rationale.The procedure was stopped.Per the customer, there was no clinical harm to the patient.Patient identifier and age are not available at this time.Patient weight and gender were obtained from rdf.The disposables set is not available for return because it was discarded by the customer.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer (Section G): TERUMO BCT; 10810 w. collins ave; lakewood CO 80215
• Manufacturer Contact: scot hilden ; 10810 w. collins ave; lakewood, CO 80215
• MDR Report Key: 12419029
• MDR Text Key: 271096409
• Report Number: 1722028-2021-00292
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 35020583122209
• UDI-Public: 35020583122209
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K183081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/03/2021

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: 04/01/2023
• Device Model Number: 12220
• Device Catalogue Number: 12220
• Device Lot Number: 2104063230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/11/2021
• Initial Date FDA Received: 09/02/2021
• Supplement Dates Manufacturer Received: 09/17/2021; 08/23/2022; 09/20/2022
• Supplement Dates FDA Received: 09/28/2021; 09/02/2022; 09/28/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/07/2021
• 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 Sex: Male
• Patient Weight: 19 KG