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

Catalog Number 12320

Device Problems Coagulation in Device or Device Ingredient (1096); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/07/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation: the run data file (rdf) was analyzed for this event.Review of the rdf and associated images for this procedure confirmed the presence of clumping in the collect connector during the procedure, appearing to worsen approximately within the hour after the first ac bag was suspected to have been changed.Therefore, it is likely that the reported clotting in the centrifuge and product bag occurred due to an unbroken frangible on the second acda bag used during the run.The spectra optia system is designed to monitor fluid presence in the ac line using the ac fluid detector.The signals in the run data file indicate that the ac fluid detector was functioning as intended, as the sensor saw fluid in the ac line during ac prime and at the beginning of the procedure.During ac prime, the system uses the inlet pressure sensor to verify that the ac line is not initially occluded.Once the procedure is started and patient blood and ac are brought into the manifold via the inlet and ac pumps, there is no way for the optia system to differentiate between the types of fluid being brought into the cassette.Consequently, the inlet pressure sensor is no longer able to check ac fluid presence during the procedure, but the ac fluid detector is still constantly monitoring for the presence of fluid in the ac line throughout the procedure.An incomplete break of the frangible on the correct connect system may be the culprit of the clotting in the product bag.This likely caused fluid to be consistently present at the ac fluid detector, while restricting flow through the ac line at the same time.If the operator suspects ac is not flowing to the system, they should verify the frangible on the correct connect system on the ac line is completely broken, there are no obstructions in the line, and fluid is dripping into the drip chamber.In general, the likelihood for platelet clumping to occur during a run is difficult to predict since it is not dependent on a specific platelet count and varies by patient.For that reason, every procedure should be observed for clumping in the connector and the collect port.If a clump is observed, 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.If clumping persists or worsens especially after a lower inlet:ac ratio has been entered, it is recommended to verify that ac fluid is flowing into the drip chamber.The operator decreased the inlet: ac ratio from 12 to 11 at 220 minutes into the run however the run was ended 12 minutes later as the clotting had worsened.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that a patient with lnh anaplastic received an additional dose of mobilization drugs after the product clotted following a continuous mononuclear cell (cmnc) collection on a spectra optia device.The additional mobilization and cell collection were needed to complete the product needed for the stem cell transplant.Per the customer, no medical intervention was required and the patient is in stable condition.The disposable set is not available for return because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provide additional information.Investigation is in process, a follow-up report will be provided.

Manufacturer Narrative

Investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.A disposable history search for lot 1904113331 was performed and found two other similar issues have been reported to terumo bct.Both incidents have been determined to be non-reportable events.Investigation is in process.A follow-up report will be reported.

Manufacturer Narrative

Investigation: further evaluation of this event has determined that the device did not cause or contribute to a death or serious injury, nor is there a likely potential for death or serious injury associated with this event based on additional investigational information.It was confirmed that no medical intervention above and beyond delay of therapy occured for this event.Root cause: review of the rdf and associated images for this procedure confirmed the presence of clumping in the collect connector during the procedure, appearing to worsen approximately within the hour after the first ac bag was suspected to have been changed.Therefore, it is likely that the reported clotting in the centrifuge and product bag occurred due to an unbroken frangible on the second acda bag used during the run.The spectra optia system is designed to monitor fluid presence in the ac line using the ac fluid detector.The signals in the run data file indicate that the ac fluid detector was functioning as intended, as the sensor saw fluid in the ac line during ac prime and at the beginning of the procedure.During ac prime, the system uses the inlet pressure sensor to verify that the ac line is not initially occluded.Once the procedure is started and patient blood and ac are brought into the manifold via the inlet and ac pumps, there is no way for the optia system to differentiate between the types of fluid being brought into the cassette.Consequently, the inlet pressure sensor is no longer able to check ac fluid presence during the procedure, but the ac fluid detector is still constantly monitoring for the presence of fluid in the ac line throughout the procedure.An incomplete break of the frangible on the correct connect system may be the culprit of the clotting in the product bag.This likely caused fluid to be consistently present at the ac fluid detector, while restricting flow through the ac line at the same time.If the operator suspects ac is not flowing to the system, they should verify the frangible on the correct connect system on the ac line is completely broken, there are no obstructions in the line, and fluid is dripping into the drip chamber.In general, the likelihood for platelet clumping to occur during a run is difficult to predict since it is not dependent on a specific platelet count and varies by patient.For that reason, every procedure should be observed for clumping in the connector and the collect port.If a clump is observed, 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.If clumping persists or worsens especially after a lower inlet:ac ratio has been entered, it is recommended to verify that ac fluid is flowing into the drip chamber.The operator decreased the inlet:ac ratio from 12 to 11 at 220 minutes into the run however the run was ended 12 minutes later as the clotting had worsened.Based on the clinical findings and run data analysis, a specific root cause for the clumping in the collect connector and product bag could not be determined.Possible causes include, but are not limited to failure to break the frangible on the correct connect for the second ac bag and/or running the procedure at a high ac ratio for the patient's physiology leading to inadequate anti-coagulation of the extra corporeal system.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA IDL SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 9266227
• MDR Text Key: 164645632
• Report Number: 1722028-2019-00322
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• PMA/PMN Number: BK150251
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/01/2019

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 Expiration Date: 04/01/2021
• Device Catalogue Number: 12320
• Device Lot Number: 1904113331
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 10/08/2019
• Initial Date FDA Received: 11/01/2019
• Supplement Dates Manufacturer Received: 11/19/2019; 01/30/2020; 02/25/2020
• Supplement Dates FDA Received: 11/25/2019; 01/31/2020; 03/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 00056 YR
• Patient Weight: 73