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

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 04/19/2022

Event Type  malfunction  

Event Description

The customer reported that half-way through a red blood cell exchange (rbcx) procedure, air was noticed in the return line.The nurse paused and flushed the return line.Then the procedure was restarted and completed.Per the customer, the patient is stable.The customer declined to provide patient identifier.The device is not available for return because the customer was able to continue the procedure with it.

Manufacturer Narrative

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

Event Description

The customer reported that half-way through a red blood cell exchange (rbcx) procedure, air was noticed in the return line.The nurse paused and flushed the return line.Then the procedure was restarted and completed.Per the customer, the patient is stable.Full patient id: (b)(6) the device is not available for return because the customer was able to continue the procedure with it.Per the customer, the patient was stable the entire time and not medical intervention was required.

Manufacturer Narrative

Investigation: the operator was able to continue the procedure but submitted two photographs in lieu of the disposable set to aid investigation.The images show the patient connected to the optia device and confirms the presence of air in the blood warmer tubing between the tubing warmer and the inlet coil.A disposable complaint history search was performed for this lot and found no reports for similar issues on this lot.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Investigation is in process.A follow up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.10.Investigation: the patient was connected at the time of the incident but was not prematurely connected prior to ac prime.Air was not being drawn in through the ac line/filter.Blood warmer 40 ml, or extracorporeal membrane l oxygenation (ecmo) was connected to the return line.There were no rlad alarms.The set was not returned as they were able to continue procedure.The operator saw the air coming through the blood warmer line and paused the machine, removed the air from the blood warmer and continued.The operator was able to finish the rbcx procedure.Patient was stable the entire time.The operator was able to continue the procedure but submitted two photographs in lieu of the disposable set to aid investigation.The images show the patient connected to the optia device and confirms the presence of air in the blood warmer tubing between the tubing warmer and the inlet coil.A disposable complaint history search was performed for this lot and found no reports for similar issues on this lot.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Root cause: based on the available information a definitive root cause could not be determined.Air in the blood warmer line that may arise if the lure connection between the return and blood warmer line is too tight that a small crack may appear, or the blood warmer may be placed too high up from the patient access point that air can develop in the line as a result.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.

Event Description

The customer reported that half-way through a red blood cell exchange (rbcx) procedure, air was noticed in the return line.The nurse paused and flushed the return line.Then the procedure was restarted and completed.Per the customer, the patient is stable.Full patient id: (b)(6) the device is not available for return because the customer was able to continue the procedure with it.Per the customer, the patient was stable the entire time and not medical intervention was required.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET,EA
• 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: 14400182
• MDR Text Key: 300142555
• Report Number: 1722028-2022-00157
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 35020583122209
• UDI-Public: 35020583122209
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK150251
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/13/2022

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: 01/02/2024
• Device Model Number: 12220
• Device Catalogue Number: 12220
• Device Lot Number: 2201183130
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/20/2022
• Initial Date FDA Received: 05/13/2022
• Supplement Dates Manufacturer Received: 12/07/2022; 01/25/2023
• Supplement Dates FDA Received: 12/15/2022; 01/31/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/20/2022
• 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: 8 YR
• Patient Sex: Female
• Patient Weight: 23 KG
• Patient Race: Black Or African American