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

Model Number 12120

Device Problems Computer Software Problem (1112); Use of Device Problem (1670); Output Problem (3005)

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

Event Date 07/16/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation: a used optia set containing blood was returned for investigation.It was noted that blood had circulated throughout the set.Additionally, blood warmer tubing was returned with the set.The ac bag was not returned with the disposable set to aid in the investigation.The disposable set was visually evaluated for any mis-assembly or defects.No mis-assemblies were noted.Clumping and clotting in the inlet filter, throughout the channel, in the collect chamber, the plasma pump header tubing, and in the return filter.Air bubbles are noted throughout the ac inlet line, the return pump header, and in the collect and recirc tubing.No kinks were identified.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that the spectra optia device was not transferring the run data info over and there is blood clotting.Per the customer the clots were in the collection bag.Clotting was noticed about 3:3 hrs into the procedure.Return pressure alarm.The customer switched lines and had the alarm again.The customer then pulled blood clots out of the ij of the catheter and the tubing.Per the customer it was at that point the patient was disconnected.The customer did not notice if the frangible was broken at the time the disposable set was unloaded.The customer looked at the saved bag of acda and thought it looked more full than originally stated when comparing it to an unopened bag.Per the customer, the frangible probably wasn't broken.Terumo bct customer support discussed with the possibility that the frangible wasn't broken and why it would not have been noticed if there was still fluid in the chamber.The customer understood the reasoning and agreed that was more than likely the problem.Per the customer the patient left without adverse event.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.10.Corrected information is provided in b.3.Investigation: a used optia set containing blood was returned for investigation.It was noted that blood had circulated throughout the set.Additionally, blood warmer tubing was returned with the set.The ac bag was not returned with the disposable set to aid in the investigation.The disposable set was visually evaluated for any mis-assembly or defects.No mis-assemblies were noted.Clumping and clotting in the inlet filter, throughout the channel, in the collect chamber, the plasma pump header tubing, and in the return filter.Air bubbles are noted throughout the ac inlet line, the return pump header, and in the collect and recirc tubing.No kinks were identified.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 the spectra optia device was not transferring the run data info over and there is blood clotting.Per the customer the clots were in the collection bag.Clotting was noticed about 3:3 hrs into the procedure.Return pressure alarm.The customer switched lines and had the alarm again.The customer then pulled blood clots out of the ij of the catheter and the tubing.Per the customer it was at that point the patient was disconnected.The customer did not notice if the frangible was broken at the time the disposable set was unloaded.The customer looked at the saved bag of acda and thought it looked more full than originally stated when comparing it to an unopened bag.Per the customer, the frangible probably wasn't broken.Terumo bct customer support discussed with the possibility that the frangible wasn't broken and why it would not have been noticed if there was still fluid in the chamber.The customer understood the reasoning and agreed that was more than likely the problem.Per the customer the patient left without adverse event.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.10.Investigation: a used optia set containing blood was returned for investigation.It was noted that blood had circulated throughout the set.Additionally, blood warmer tubing was returned with the set.The ac bag was not returned with the disposable set to aid in the investigation.The disposable set was visually evaluated for any mis-assembly or defects.No mis-assemblies were noted.Clumping and clotting in the inlet filter, throughout the channel, in the collect chamber, the plasma pump header tubing, and in the return filter.Air bubbles are noted throughout the ac inlet line, the return pump header, and in the collect and recirc tubing.No kinks were identified.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 other report for similar issues on this lot.Correction: terumobct clinical specialist discussed with her the possibility that the frangible was not broken, and the fluid from the first ac bag would remain in the ac line, hence there were no alarm to alert her that there was no ac flow.She understood the reasoning and agreed that was more than likely the problem.Root cause: a root cause assessment was performed for this complaint.The root cause was determined to be the failure to break the frangible after connecting the second bag of acda.

Event Description

The customer reported that the spectra optia device was not transferring the run data info over and there is blood clotting.Per the customer the clots were in the collection bag.Clotting was noticed about 3:3 hrs into the procedure.Return pressure alarm.The customer switched lines and had the alarm again.The customer then pulled blood clots out of the ij of the catheter and the tubing.Per the customer it was at that point the patient was disconnected.The customer did not notice if the frangible was broken at the time the disposable set was unloaded.The customer looked at the saved bag of acda and thought it looked more full than originally stated when comparing it to an unopened bag.Per the customer, the frangible probably wasn't broken.Terumo bct customer support discussed with the possibility that the frangible wasn't broken and why it would not have been noticed if there was still fluid in the chamber.The customer understood the reasoning and agreed that was more than likely the problem.Per the customer the patient left without adverse event.

• 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: 12651463
• MDR Text Key: 279542013
• Report Number: 1722028-2021-00326
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583121201
• UDI-Public: 05020583121201
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date: 10/18/2021

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: 05/01/2023
• Device Model Number: 12120
• Device Catalogue Number: 12120
• Device Lot Number: 2105243130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2021
• Initial Date Manufacturer Received: 09/23/2021
• Initial Date FDA Received: 10/18/2021
• Supplement Dates Manufacturer Received: 01/13/2022; 06/10/2022
• Supplement Dates FDA Received: 01/21/2022; 06/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/27/2021
• 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: 63 YR
• Patient Sex: Male
• Patient Weight: 102 KG