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

Model Number 12120

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problems Hypervolemia (2664); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/29/2022

Event Type  malfunction  

Event Description

The customer reported that during an apheresis treatment on a 16kg child, the operator did not close the saline line clamp.The 1000ml bag was emptied.The customer reported that no medical intervention was necessary.Patient id, age, and gender are not available at this time.Terumo bct is awaiting the return of the device.

Manufacturer Narrative

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

Event Description

The customer reported that during a mononuclear cell (mnc) collection treatment on a 16kg child, the operator did not close the saline line clamp.The 1000ml bag was emptied.As the operator closed the lines on the saline, the interface realigned.Control of electrolytes and blood morphology at the moment when the empty saline container has been noticed.Routine continuous blood pulse and saturation and regular blood pressure control was performed during the whole apheresis procedure, as well (and no abnormal values were observed).As the patient was in good condition ¿ including general status, heart rate, saturation, blood pressure, blood electrolytes and morphology the procedure has not been stopped.It became effective then and expected number of cells has been collected (in 60 ml of final product).The empty saline container was replaced by a new one but no more saline was used/given to the patient as the procedure was finished without reinfusion.The patient urinated much and balanced the unexpected saline infusion in this case with no consequences.The customer reported that no medical intervention was necessary and patient is reported as "ok".Due to eu personal data protection laws, further patient information is not available from the customer.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 b.5, d.9, h.6 and h.11 investigation: per the customer, the operator has 20 years of experience.Custom prime with rbc concentrate unit (200 ml hct 72%) had been done before the patient was connected to the apheresis machine.Patient adjusted final fluid balance (with 703 ml unintended saline bolus) = [(1200 ml x 1.35) + 703 ml) / 1200 ml x 100% = 193.4 % a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.A disposable lot history search indicated there were no other reported occurrence of open inlet saline roller clamp on this lot worldwide.Root cause: a root cause assessment was performed for the unintended saline bolus to the patient.Based on the customer's statements, the operator failed to follow the screen prompts to fully close the inlet saline roller clamp at the end of saline prime.

Manufacturer Narrative

This report is being filed to provide additional information in a.3a, b.5, b.6, b.7, h.6 and h.10 (h.11).Investigation: per the customer, the operator has 20 years of experience.Custom prime with rbc concentrate unit (200 ml hct 72%) had been done before the patient was connected to the apheresis machine.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.

Event Description

The customer reported that during a mononuclear cell (mnc) collection treatment on a 16kg child, the operator did not close the saline line clamp.The 1000ml bag was emptied.As the operator closed the lines on the saline, the interface realigned.Control of electrolytes and blood morphology at the moment when the empty saline container has been noticed.Routine continuous blood pulse and saturation and regular blood pressure control was performed during the whole apheresis procedure, as well (and no abnormal values were observed).As the patient was in good condition ¿ including general status, heart rate, saturation, blood pressure, blood electrolytes and morphology the procedure has not been stopped.It became effective then and expected number of cells has been collected (in 60 ml of final product).The empty saline container was replaced by a new one but no more saline was used/given to the patient as the procedure was finished without reinfusion.The patient urinated much and balanced the unexpected saline infusion in this case with no consequences.The customer reported that no medical intervention was necessary and patient is reported as "ok".Due to eu personal data protection laws, further patient information is not available from the customer.Terumo bct is awaiting the return of the device.

Manufacturer Narrative

This report is being filed to provide additional information in b.5, d.9, h.6 and h.11 investigation: per the customer, the operator has 20 years of experience.Custom prime with rbc concentrate unit (200 ml hct 72%) had been done before the patient was connected to the apheresis machine.Patient adjusted final fluid balance (with 703 ml unintended saline bolus) = [(1200 ml x 1.35) + 703 ml) / 1200 ml x 100% = 193.4 % a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.A disposable lot history search indicated there were no other reported occurrence of open inlet saline roller clamp on this lot worldwide.Root cause: a root cause assessment was performed for the unintended saline bolus to the patient.Based on the customer's statements, the operator failed to follow the screen prompts to fully close the inlet saline roller clamp at the end of saline prime.

Event Description

The customer reported that during a mononuclear cell (mnc) collection treatment on a 16kg child, the operator did not close the saline line clamp.The 1000ml bag was emptied.As the operator closed the lines on the saline, the interface realigned.Control of electrolytes and blood morphology at the moment when the empty saline container has been noticed.Routine continuous blood pulse and saturation and regular blood pressure control was performed during the whole apheresis procedure, as well (and no abnormal values were observed).As the patient was in good condition ¿ including general status, heart rate, saturation, blood pressure, blood electrolytes and morphology the procedure has not been stopped.It became effective then and expected number of cells has been collected (in 60 ml of final product).The empty saline container was replaced by a new one but no more saline was used/given to the patient as the procedure was finished without reinfusion.The patient urinated much and balanced the unexpected saline infusion in this case with no consequences.The customer reported that no medical intervention was necessary and patient is reported as "ok".Due to eu personal data protection laws, further patient information is not available from the customer.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 b.5, d.9, h.6 and h.11 investigation: per the customer, the operator has 20 years of experience.Custom prime with rbc concentrate unit (200 ml hct 72%) had been done before the patient was connected to the apheresis machine.Patient adjusted final fluid balance (with 703 ml unintended saline bolus) = [(1200 ml x 1.35) + 703 ml) / 1200 ml x 100% = 193.4 % a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.A disposable lot history search indicated there were no other reported occurrence of open inlet saline roller clamp on this lot worldwide.Root cause: a root cause assessment was performed for the unintended saline bolus to the patient.Based on the customer's statements, the operator failed to follow the screen prompts to fully close the inlet saline roller clamp at the end of saline prime.

Event Description

The customer reported that during a mononuclear cell (mnc) collection treatment on a 16kg child, the operator did not close the saline line clamp.The 1000ml bag was emptied.As the operator closed the lines on the saline, the interface realigned.Control of electrolytes and blood morphology at the moment when the empty saline container has been noticed.Routine continuous blood pulse and saturation and regular blood pressure control was performed during the whole apheresis procedure, as well (and no abnormal values were observed).As the patient was in good condition ¿ including general status, heart rate, saturation, blood pressure, blood electrolytes and morphology the procedure has not been stopped.It became effective then and expected number of cells has been collected (in 60 ml of final product).The empty saline container was replaced by a new one but no more saline was used/given to the patient as the procedure was finished without reinfusion.The patient urinated much and balanced the unexpected saline infusion in this case with no consequences.The customer reported that no medical intervention was necessary and patient is reported as "ok".Due to eu personal data protection laws, further patient information is not available from the customer.The collection set is not available for return because it was discarded by the customer.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA COLLECT 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: 15079502
• MDR Text Key: 304442116
• Report Number: 1722028-2022-00238
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583121201
• UDI-Public: 05020583121201
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: BK150251
• 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,Followup
• Report Date: 07/21/2022

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: 12/02/2023
• Device Model Number: 12120
• Device Catalogue Number: 12120
• Device Lot Number: 2112103330
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/30/2022
• Initial Date FDA Received: 07/21/2022
• Supplement Dates Manufacturer Received: 03/07/2024; 03/25/2024; 04/08/2024; 04/08/2024
• Supplement Dates FDA Received: 03/18/2024; 04/05/2024; 04/08/2024; 04/08/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/03/2021
• 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 Age: 4 YR
• Patient Sex: Female
• Patient Weight: 16 KG