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

Catalog Number 4122201

Device Problems Use of Device Problem (1670); Insufficient Information (3190)

Patient Problem Air Embolism (1697)

Event Date 06/24/2023

Event Type  Injury  

Manufacturer Narrative

Investigation: a disposable complaint history search was performed for this lot and found no reports for similar issues on this lot.Correction: internal retraining was completed on (b)(6) 2023.A message was sent to all staff at the customer organization which included informing them of the error in the setup of the optia machine which resulted in the patient receiving air into their vein, the potential impact if more air had entered the patient circulatory system, asking them to double check that the optia machine¿s tubes and blood warmer¿s set are fully primed before commencing treatment, and that there is no alarm on the blood warming device to alert them of air within the tube, so requires manual checks.Investigation is in process, a follow-up report will be provided.

Event Description

The customer reported that during a procedure on a spectra optia the patient seemed to be unwell.The operator then noticed they had not primed the astotherm blood warmer tubing.The operator paused and then ended the procedure.The patient recovered after high flow oxygen was administered.According to the customer it was clear the patient did receive an amount of air from the unprimed tubing line, however, it is unknown how much the patient received.The customer said all luer connections were tight and there was no clotting in the channel or in the return reservoir.The patient is in stable condition.Patient id is unknown at this time.The collection set is not available for return because it was discarded by the customer.

Event Description

The customer reported that during a procedure on a spectra optia the patient seemed to be unwell.The operator then noticed they had not primed the astotherm blood warmer tubing.The operator paused and then ended the procedure.The patient recovered after high flow oxygen was administered.According to the customer it was clear the patient did receive an amount of air from the unprimed tubing line, however, it is unknown how much the patient received.The customer said all luer connections were tight and there was no clotting in the channel or in the return reservoir.The patient is in stable condition.The collection 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 a.1, h.6 and h.10.Investigation: 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.In this incident, two tas nurses were involved; the first nurse prepared the optia machine ready for use and the second nurse initiated the treatment.The first nurse prepared the machine including priming the tubes connected to the machine.However, a separate tube (blood warmer coil) that is separate from the machine kit but also needs to be attached to the machine to initiate the procedure.This tube was connected to the machine but was not primed by the nurse.There is an alarm in optia machine that alert staff of air in the tubes, but there is no alarm on the blood warming device to alert staff of air within the blood warmer coil.A second nurse attended to treat the patient, connected the patient to the machine and started the procedure without double checking that the blood warmer coil was indeed primed.The customer said all luer connections were tight and there was no clotting in the channel or in the return reservoir.Correction: internal retraining was completed on 29 june 2023.A message was sent to all staff at the customer organization which included informing them of the error in the setup of the optia machine which resulted in the patient receiving air into their vein, the potential impact if more air had entered the patient circulatory system, asking them to double check that the optia machine's tubes and blood warmer's set are fully primed before commencing treatment, and that there is no alarm on the blood warming device to alert them of air within the tube, so requires manual checks.Investigation is in process, a follow-up report will be provided.

Event Description

An adult patient attended a therapeutic apheresis services (tas) units for red cell exchange (rce) procedure for the treatment of sickle cell disorder.Prior to the procedure the optia machine is usually prepared ready for use including priming the tubes used for the rce.The customer reported that during the procedure the patient seemed to be unwell.The operator then noticed they had not primed the astotherm blood warmer tubing.The operator paused and then ended the procedure.The patient recovered after medical intervention of high flow oxygen delivered to patient by two nurse specialists.The patient was transferred to a&e (accident and emergency) to be checked by a medical team and was discharged on the same evening.There was no further medical intervention following the high flow oxygen.A verbal report of the incident to the account manager noted that the patient did receive an amount of air from the unprimed tubing line but remained well.The customer said all luer connections were tight and there was no clotting in the channel or in the return reservoir.The collection set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Investigation: 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.In this incident, two tas nurses were involved; the first nurse prepared the optia machine ready for use and the second nurse initiated the treatment.The first nurse prepared the machine including priming the tubes connected to the machine.However, a separate tube (blood warmer coil) that is separate from the machine kit but also needs to be attached to the machine to initiate the procedure.This tube was connected to the machine but was not primed by the nurse.There is an alarm in optia machine that alert staff of air in the tubes, but there is no alarm on the blood warming device to alert staff of air within the blood warmer coil.A second nurse attended to treat the patient, connected the patient to the machine and started the procedure without double checking that the blood warmer coil was indeed primed.The customer said all luer connections were tight and there was no clotting in the channel or in the return reservoir.The run data file (rdf) was analyzed for this event.The reported incident stated that for the rbc exchange-depletion procedure, the blood warmer tubing located on the return line was inadvertently not primed prior to starting the run and some air may have been returned to the patient.Review of the run data file confirmed that the rbcx-d procedure was configured for blood warmer tubing on the return line with a 40ml volume.The appropriate alarm to ¿check connection from return line to blood warmer tubing¿ was generated immediately after the run was started.The procedure continued for 128 minutes until the operator ended the run with no patient rinseback.Analysis of the procedure showed that at 4 minutes into the run, the system accumulated return pump volume was 53 mls.This would be sufficient volume for the return pump to push the fluid in the optia return line (12mls) plus the contents of the blood warmer tubing (37.5mls) through the lines to the patient access.In the first 4 minutes, the pause button was pressed once, and 2 return pressure alarms occurred stopping the pumps for slightly over 1 minute in this timeframe.The optia system has two safety methods for detecting air in the set; the primary detection is the reservoir low-level sensor, and the secondary is the return line air detector (rlad) located on the outlet of the return pump.The blood warmer is attached to the end of the optia return line so located past both of these safety detection methods.There are warnings and instructions located in the spectra optia operator¿s manual and a screen that prompts the operator to prime the blood warmer tubing prior to patient connection.In addition, after the run is started, a prompt is generated to check that the blood warmer tubing is connected securely and at the correct height for proper operation.The terumo bct medical safety team concluded that, based on the clinical information provided, the spectra optia performed as intended, there were no suggested device failures, malfunctions, mislabeling, improper or inadequate design or manufacturing errors.However, there was a reported use error of the blood warmer tubing not being primed which contributed to or caused this adverse event.Correction: internal retraining was completed on (b)(6) 2023.A message was sent to all staff at the customer organization which included informing them of the error in the setup of the optia machine which resulted in the patient receiving air into their vein, the potential impact if more air had entered the patient circulatory system, asking them to double check that the optia machine¿s tubes and blood warmer¿s set are fully primed before commencing treatment, and that there is no alarm on the blood warming device to alert them of air within the tube, so requires manual checks.Root cause: a root cause assessment was performed for this complaint.The root cause was determined to be a user error where they did not prime the blood warmer tubing.

Manufacturer Narrative

This report is being filed to provide additional information in b.5, b.6 and h.10.Investigation: 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.In this incident, two tas nurses were involved; the first nurse prepared the optia machine ready for use and the second nurse initiated the treatment.The first nurse prepared the machine including priming the tubes connected to the machine.However, a separate tube (blood warmer coil) that is separate from the machine kit but also needs to be attached to the machine to initiate the procedure.This tube was connected to the machine but was not primed by the nurse.There is an alarm in optia machine that alert staff of air in the tubes, but there is no alarm on the blood warming device to alert staff of air within the blood warmer coil.A second nurse attended to treat the patient, connected the patient to the machine and started the procedure without double checking that the blood warmer coil was indeed primed.The customer said all luer connections were tight and there was no clotting in the channel or in the return reservoir.The run data file (rdf) was analyzed for this event.The reported incident stated that for the rbc exchange-depletion procedure, the blood warmer tubing located on the return line was inadvertently not primed prior to starting the run and some air may have been returned to the patient.Review of the run data file confirmed that the rbcx-d procedure was configured for blood warmer tubing on the return line with a 40ml volume.The appropriate alarm to ¿check connection from return line to blood warmer tubing¿ was generated immediately after the run was started.The procedure continued for 128 minutes until the operator ended the run with no patient rinseback.Analysis of the procedure showed that at 4 minutes into the run, the system accumulated return pump volume was 53 mls.This would be sufficient volume for the return pump to push the fluid in the optia return line (12mls) plus the contents of the blood warmer tubing (37.5mls) through the lines to the patient access.In the first 4 minutes, the pause button was pressed once, and 2 return pressure alarms occurred stopping the pumps for slightly over 1 minute in this timeframe.The optia system has two safety methods for detecting air in the set; the primary detection is the reservoir low-level sensor, and the secondary is the return line air detector (rlad) located on the outlet of the return pump.The blood warmer is attached to the end of the optia return line so located past both of these safety detection methods.There are warnings and instructions located in the spectra optia operator¿s manual and a screen that prompts the operator to prime the blood warmer tubing prior to patient connection.In addition, after the run is started, a prompt is generated to check that the blood warmer tubing is connected securely and at the correct height for proper operation.The terumo bct medical safety team concluded that, based on the clinical information provided, the spectra optia performed as intended, there were no suggested device failures, malfunctions, mislabeling, improper or inadequate design or manufacturing errors.However, there was a reported use error of the blood warmer tubing not being primed which contributed to or caused this adverse event.Correction: internal retraining was completed on (b)(6) 2023.A message was sent to all staff at the customer organization which included informing them of the error in the setup of the optia machine which resulted in the patient receiving air into their vein, the potential impact if more air had entered the patient circulatory system, asking them to double check that the optia machine¿s tubes and blood warmer¿s set are fully primed before commencing treatment, and that there is no alarm on the blood warming device to alert them of air within the tube, so requires manual checks.Investigation is in process, a follow-up report will be provided.

Event Description

An adult patient attended a therapeutic apheresis services (tas) units for red cell exchange (rce) procedure for the treatment of sickle cell disorder.Prior to the procedure the optia machine is usually prepared ready for use including priming the tubes used for the rce.The customer reported that during the procedure the patient seemed to be unwell.The operator then noticed they had not primed the astotherm blood warmer tubing.The operator paused and then ended the procedure.The patient recovered after medical intervention of high flow oxygen delivered to patient by two nurse specialists.The patient was transferred to a&e (accident and emergency) to be checked by a medical team and was discharged on the same evening.There was no further medical intervention following the high flow oxygen.A verbal report of the incident to the account manager noted that the patient did receive an amount of air from the unprimed tubing line but remained well.The customer said all luer connections were tight and there was no clotting in the channel or in the return reservoir.The collection 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: 17459944
• MDR Text Key: 320402029
• Report Number: 1722028-2023-00269
• Device Sequence Number: 1
• Product Code: LKN
• 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: 08/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 4122201
• Device Lot Number: 2303143141
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/08/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/14/2023
• 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: 27 YR
• Patient Sex: Female
• Patient Weight: 80 KG