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

Catalog Number 12120

Device Problems Occlusion Within Device (1423); Decrease in Pressure (1490); Unexpected Therapeutic Results (1631); Use of Device Problem (1670); Device Displays Incorrect Message (2591)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 05/14/2018

Event Type  malfunction  

Manufacturer Narrative

Investigation: per the customer, the stem cell laboratory reported that the product was clotted and had to be filtered to remove the clots.The customer stated that they observed yellow and white clots in the return filter.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that during a mononuclear cell (mnc) collection procedure, they received a 'collected line is obstructed' and a "return pressure high" alarm.The nurse stated while flushing, they observed a small clot in the collect line at return filter.Per the customer, the plasma and platelets were not returned to the donor.Patient (donor) information or outcome is not available at this time.The spectra optia 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.Investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Root cause: review of the dlog and associated images for this procedure confirmed the presence of clumping/platelet aggregation in the connector starting approximately 60 minutes into the run.The clumping continued and worsened until at 128 minutes where images indicate clumps were entering the collect port.It is possible that the clumping partially/fully obstructed the collect port which prevented the system from establishing the interface in the connector.This is evidenced by the two ¿interface took too long to establish¿ alarms generated shortly before the operator ended the run.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.Therefore, every procedure should be observed for clumping in the connector, particularly at the interface before the collect port, and in the collect port.If a clump is observed in these locations, it is best to eliminate it and stop the clotting cascade as quickly as possible by reducing the inlet: ac ratio to 8.In this particular case, the inlet: ac ratio remained at 11 until 170 minutes into the procedure when the operator decreased the ratio to 10 and increased the ac infusion rate to 0.97ml/min/ltbv.Images suggest that this action was not sufficient to address the clumping already present in the connector and collect port.Consequently, properly addressing the clumping/platelet aggregation early on by reducing the inlet: ac ratio to 8 would likely have improved the outcome of the procedure.The images from the aim system showed there was significant buffy coat accumulation in the connector throughout the run.A steady, defined buffy coat should not accumulate in the connector above the skimmer dam.This means the system is not efficiently removing the target cells from the connector.You can see this by looking through the view port at the interface.There will be a buffy coat layer on top of the rbc layer.You may also see a consistent row of the green diamonds above the target collection preference.An accumulation of a buffy coat can occur when a patient has high counts (wbc=30 and plt=200), if the cp is set too high, if the pumps have paused several times, and/or if patient data was entered incorrectly.The recommended action in response to an accumulation of buffy coat is to decrease the collection preference (cp) by 10, with the minimum possible cp being 20.The only adjustment to the cp was to increase it by 10 at 68 minutes into the procedure.Therefore, it may have helped to decrease the cp when the buffy coat accumulation was occurring.Review of the dlogs for this procedure also showed an increased number of return pressure alarms which may have contributed to the reported issue.In total, there were 22 access pressure alarms (1 inlet and 21 return).Excessive pressure alarms cause the pumps to pause and the system to re-establish the interface, which in turn affects how well the buffy coat is separated.Although the chamber is still filling during interface setup, the system is not collecting at the target cp and is not efficiently filling the chamber with the desired target cells.The most common source of pressure alarms is when the inlet flow rate is set too high for the given patient access or the patient access is not properly positioned.In response to these alarms, it is suggested to check the positioning of the patient access and lower the inlet flow rate.The inlet flow rate was set at 65ml/min for a majority of the run.The operator did initially reduce the inlet flow rate in response to the alarms; however, they subsequently increased it later, resulting in additional alarms.Ensuring the patient access is appropriately sized, nothing is blocking the access, the inlet flow rate is not too high, and generally controlling access issues is important as these can greatly contribute to the success of a procedure.

Event Description

Due to eu personal data protection laws, the patient's identifier and age is not available from the customer.Patient's gender and weight were obtained from the run data file (rdf).

Manufacturer Narrative

This report is being filed to provide additional information.Investigation:the run data file (rdf) was analyzed for this event review of the dlog and associated images for this procedure confirmed the presence of clumping/platelet aggregation in the connector starting approximately 60 minutes into the run.The clumping continued and worsened until at 128 minutes where images indicate clumps were entering the collect port.It is possible that the clumping partially/fully obstructed the collect port which prevented the system from establishing the interface in the connector.This is evidenced by the two ¿interface took too long to establish¿ alarms generated shortly before the operator ended the run.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.In this particular case, the inlet: ac ratio remained at 11 until 170 minutes into the procedure when the operator decreased the ratio to 10 and increased the ac infusion rate to 0.97ml/min/ltbv.Images suggest that this action was not sufficient to address the clumping already present in the connector and collect port.The images from the aim system showed there was significant buffy coat accumulation in the connector throughout the run.A steady, defined buffy coat should not accumulate in the connector above the skimmer dam.This means the system is not efficiently removing the target cells from the connector.You can see this by looking through the view port at the interface.There will be a buffy coat layer on top of the rbc layer.You may also see a consistent row of the green diamonds above the target collection preference.An accumulation of a buffy coat can occur when a patient has high counts (wbc=30 and plt=200), if the cp is set too high, if the pumps have paused several times, and/or if patient data was entered incorrectly.The only adjustment to the cp was to increase it by 10 at 68 minutes into the procedure.Therefore, it may have helped to decrease the cp when the buffy coat accumulation was occurring.Review of the dlogs for this procedure also showed an increased number of return pressure alarms which may have contributed to the reported issue.In total, there were 22 access pressure alarms (1 inlet and 21 return).Excessive pressure alarms cause the pumps to pause and the system to re-establish the interface, which in turn affects how well the buffy coat is separated.Although the chamber is still filling during interface setup, the system is not collecting at the target cp and is not efficiently filling the chamber with the desired target cells.The most common source of pressure alarms is when the inlet low rate is set too high for the given patient access or the patient access is not properly positioned.The inlet flow rate was set at 65ml/min for a majority of the run.The operator did initially reduce the inlet flow rate in response to the alarms; however, they subsequently increased it later on, resulting in additional alarms.Investigation is in process.A follow-up report will be provided.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA COLLECT SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10810 w. collins ave.; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 7584180
• MDR Text Key: 111021127
• Report Number: 1722028-2018-00164
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: K153601
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/08/2018

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: 02/01/2020
• Device Catalogue Number: 12120
• Device Lot Number: 1802063230
• Other Device ID Number: 05020583121201
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 05/17/2018
• Initial Date FDA Received: 06/08/2018
• Supplement Dates Manufacturer Received: 07/05/2018; 10/19/2018
• Supplement Dates FDA Received: 07/27/2018; 10/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/13/2018
• 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 Weight: 119