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

Catalog Number 4122201

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Diarrhea (1811); Low Blood Pressure/ Hypotension (1914); Nausea (1970); Vomiting (2144)

Event Date 02/20/2023

Event Type  Injury  

Manufacturer Narrative

Investigation: per customer follow-up they had used 1l of normal saline and there was a bit over 1l of blood/saline in the saline bag.They did not perform rinseback to return the blood in the saline bag to the patient because the staff was in crisis due to the patient's condition.They gave the patient a separate fluid bolus because ¿they were afraid to do a rinse back with that bag due to not knowing the true volume and potential malfunction of the machine during this time.It was felt better to leave that bag as it was vs potentially causing other issues.A terumo bct service technician checked out the machine at the customer site.A machine checkout was performed with complete autotest and a saline run.The pressure transducer calibrations and electrical safety were verified.The machine was found to meet manufacturer specifications.According to therapeutic apheresis: a physician's handbook, adverse events occur during therapeutic procedures with a frequency of 4.8%.Some of the most common reactions include fever, urticaria, hypocalcemic symptoms, pruritus, dyspnea, tachycardia, and mild hypotension.Vasovagal incidents occur around 0.5% of procedures.The reactions generally manifest as pallor and diaphoresis.In a full blown attack, the reaction progresses from pallor and sweating to pulse slowing and blood pressure decreasing.More severe vasovagal reactions may include nausea, vomiting, and/or convulsions the run data file was analyzed for this event.Review of the dlog shows the return pressure sensor readings climbed as the procedure progressed.The observed return pressure behavior may have been caused by increased amount of fluid in the saline bag and may be evidence that the saline roller clamp on the return line remained open during the procedure.When the return saline roller clamp is fully or partially open a clear path is open between the patient access site, the return pump, and the saline bag.Some of the fluid pumped by the return pump will flow into the saline bag when the return pump is active.When the return pump pauses, fluid in the saline bag may drip down to the patient access until the next time the return pump activates.Up until rinseback was started, a total of 1828 ml of fluid was returned by the return pump at an average hct of 25.4%.A total of 58 ml of fluid was returned during rinseback.Using values from the dlog and considering a 1l saline bag was used for this procedure, it is estimated that there were 790 ml of saline in the saline bag after the saline divert was complete at start of procedure.After the procedure was ended, the customer reported there was a final amount of just over 1l volume in the saline bag.Given these values it is estimated that at least 210 ml of the returned fluid was redirected to the saline bag.An exact value of return volume which ended up in saline bag cannot be obtained from dlog.Estimated volume of blood in the saline bag = 210 ml estimated volume of blood in the saline line = 12.49 ml + 5.0 ml + 3.6 ml = 21.1 ml patient blood loss after diverting a portion of blood into the saline bag = 210 ml + 21.1 ml / 5504 ml x 100% = 4.2 % in addition, aim image review showed some evidence of minor clumping present in the channel connector.The occurrence of clumping in the channel connector did not influence the presence of blood in the saline bag.The likelihood for platelet clumping to occur during a procedure is difficult to predict since it is not dependent on a specific platelet count and varies by patient.Therefore, every procedure should be observed for clumping in the connector and the collect port.If a clump is observed or suspected, it is best to eliminate it and stop the clotting cascade as quickly as possible by reducing the inlet:ac ratio to 8.Once a clump has been resolved, a ratio that maintains adequate separation should be used.The inlet:ac ratio was maintained at 12 throughout the procedure analyzed.Aim image review also suggested there may be residue present on the aperture plate since some residue was evident.This is a secondary observation and did not influence the presence of blood in the saline bag.Depending on severity, residue on the aperture plate can cause bright imaging which may affect the function of the aim system.In tpe the aim system does not have direct control of the positioning of the interface and only monitors the interface position and triggers a platelet return when buffy coat accumulation is detected.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Correction: the terumo bct field performance team engineer shared the dlog analysis findings and recommendations with the customer.Investigation is in process.A follow up report will be provided.

Event Description

The customer reported that a myasthenia gravis patient complained of nausea and thought she would have diarrhea during a therapeutic plasma exchange (tpe) procedure.Per the customer, she got really "excited" with a blood pressure of 109/42.30 minutes into the procedure, her blood pressure dropped and she became pale.The operator was going to stop the procedure and the patient decompensated.He initiated rinseback, and the patient threw up and became unresponsive.One of the nurses noticed that the saline bag was filling up with blood.According to the customer, the procedure was uneventful up to that point.It appeared that there was about a unit of blood in the saline bag.The operator indicated that the blue saline roller clamp was closed.Rapid response was called and her blood pressure was 67/40.She was given 450 ml of saline bolus and her blood pressure was 160/78.The patient was later admitted to the emergency room and her blood pressure was 110/56.Her vital signs had improved but she still complained of nausea and diarrhea.Per the customer, the patient had taken 37.5 mg toprol before the procedure.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 in h.6 and h.10.Corrected information is provided in d.2b.Investigation: per customer follow-up they had used 1l of normal saline and there was a bit over 1l of blood/saline in the saline bag.They did not perform rinseback to return the blood in the saline bag to the patient because the staff was in crisis due to the patient's condition.They gave the patient a separate fluid bolus because ¿they were afraid to do a rinse back with that bag due to not knowing the true volume and potential malfunction of the machine during this time.It was felt better to leave that bag as it was vs potentially causing other issues.A terumo bct service technician checked out the machine at the customer site.A machine checkout was performed with complete autotest and a saline run.The pressure transducer calibrations and electrical safety were verified.The machine was found to meet manufacturer specifications.According to therapeutic apheresis: a physician's handbook, adverse events occur during therapeutic procedures with a frequency of 4.8%.Some of the most common reactions include fever, urticaria, hypocalcemic symptoms, pruritus, dyspnea, tachycardia, and mild hypotension.Vasovagal incidents occur around 0.5% of procedures.The reactions generally manifest as pallor and diaphoresis.In a full blown attack, the reaction progresses from pallor and sweating to pulse slowing and blood pressure decreasing.More severe vasovagal reactions may include nausea, vomiting, and/or convulsions the run data file was analyzed for this event.Review of the dlog shows the return pressure sensor readings climbed as the procedure progressed.The observed return pressure behavior may have been caused by increased amount of fluid in the saline bag and may be evidence that the saline roller clamp on the return line remained open during the procedure.When the return saline roller clamp is fully or partially open a clear path is open between the patient access site, the return pump, and the saline bag.Some of the fluid pumped by the return pump will flow into the saline bag when the return pump is active.When the return pump pauses, fluid in the saline bag may drip down to the patient access until the next time the return pump activates.Up until rinseback was started, a total of 1828 ml of fluid was returned by the return pump at an average hct of 25.4%.A total of 58 ml of fluid was returned during rinseback.Using values from the dlog and considering a 1l saline bag was used for this procedure, it is estimated that there were 790 ml of saline in the saline bag after the saline divert was complete at start of procedure.After the procedure was ended, the customer reported there was a final amount of just over 1l volume in the saline bag.Given these values it is estimated that at least 210 ml of the returned fluid was redirected to the saline bag.An exact value of return volume which ended up in saline bag cannot be obtained from dlog.Estimated volume of blood in the saline bag = 210 ml estimated volume of blood in the saline line = 12.49 ml + 5.0 ml + 3.6 ml = 21.1 ml patient blood loss after diverting a portion of blood into the saline bag = 210 ml + 21.1 ml / 5504 ml x 100% = 4.2 % in addition, aim image review showed some evidence of minor clumping present in the channel connector.The occurrence of clumping in the channel connector did not influence the presence of blood in the saline bag.The likelihood for platelet clumping to occur during a procedure is difficult to predict since it is not dependent on a specific platelet count and varies by patient.Therefore, every procedure should be observed for clumping in the connector and the collect port.If a clump is observed or suspected, it is best to eliminate it and stop the clotting cascade as quickly as possible by reducing the inlet:ac ratio to 8.Once a clump has been resolved, a ratio that maintains adequate separation should be used.The inlet:ac ratio was maintained at 12 throughout the procedure analyzed.Aim image review also suggested there may be residue present on the aperture plate since some residue was evident.This is a secondary observation and did not influence the presence of blood in the saline bag.Depending on severity, residue on the aperture plate can cause bright imaging which may affect the function of the aim system.In tpe the aim system does not have direct control of the positioning of the interface and only monitors the interface position and triggers a platelet return when buffy coat accumulation is detected.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.Correction: the terumo bct field performance team engineer shared the dlog analysis findings and recommendations with the customer.Root cause: a root cause assessment was performed for the adverse reactions.Based on the available information a definitive root cause could not be determined.Vasovagal are common side effects of therapeutic apheresis procedures.They are typically caused by the patient's disease state, the medication the patient took before the procedure, the rate of ac infusion, the patient's sensitivity to the procedure and/or the hemodynamic stress of the procedure.A root cause assessment was performed for the diversion of blood into the saline bag.Based on the available information a definitive root cause could not be determined but it is likely due to one or a combination of the possible causes listed below: * the return saline roller clamp was inadvertently left partially open allowing some of the patient¿s blood to be diverted up into the saline bag.* a defective return saline roller clamp which resulted in some of the patient¿s blood to be diverted up into the saline bag.

Event Description

The customer reported that a myasthenia gravis patient complained of nausea and thought she would have diarrhea during a therapeutic plasma exchange (tpe) procedure.Per the customer, she got really "excited" with a blood pressure of 109/42.30 minutes into the procedure, her blood pressure dropped and she became pale.The operator was going to stop the procedure and the patient decompensated.He initiated rinseback, and the patient threw up and became unresponsive.One of the nurses noticed that the saline bag was filling up with blood.According to the customer, the procedure was uneventful up to that point.It appeared that there was about a unit of blood in the saline bag.The operator indicated that the blue saline roller clamp was closed.Rapid response was called and her blood pressure was 67/40.She was given 450 ml of saline bolus and her blood pressure was 160/78.The patient was later admitted to the er and her blood pressure was 110/56.Her vital signs had improved but she still complained of nausea and diarrhea.Per the customer, the patient had taken 37.5 mg toprol before the procedure.The exchange 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: 16553269
• MDR Text Key: 311402793
• Report Number: 1722028-2023-00107
• Device Sequence Number: 1
• Product Code: LKN
• 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
• Report Date: 03/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 2212286141
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/20/2023
• Initial Date FDA Received: 03/16/2023
• Supplement Dates Manufacturer Received: 03/16/2023
• Supplement Dates FDA Received: 04/10/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/28/2022
• 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; Hospitalization
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 108 KG