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

Model Number 10310

Device Problems Backflow (1064); Use of Device Problem (1670)

Patient Problems Hypovolemia (2243); Reaction (2414)

Event Date 12/05/2019

Event Type  Injury  

Manufacturer Narrative

Investigation: a terumo bct service technician checked out the device at the customer site.The technician verified pressures and a complete auto test and saline run were successfully completed.Per the customer, the saline roller clamp was on the correct line and there were no level sensor or fluid balance alarms.The reported saline bag used was 1000ml.Per the customer, the approximate final volume of the bag was 800ml.Approximate final fluid balance (including saline bolus): ecv 297+ 40 ml of blood warmer tubing= 337 ml of saline used to prime approx.Saline bag should have 663 ml left after priming since the bag is 1000 ml.Per picture the saline bag has approx.200 ml of packed red cells 660ml tbv - 200 ml of red cells in the saline bag = 460 ml 460ml / 660 tbv=.70% fb approx.During follow-up with the customer, terumo bct customer support explained that they did not get a return pressure high alarm even that the return clamp was closed because the blood had a clear pathway in the saline line since it was open.The curse confirmed understanding of this.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that 35 minutes into a continuous mononuclear cell (cmnc) collection on a pediatric patient with neuroblastoma using a spectra optia device, it was found that the blood was going into the return line and the saline bag.Per the customer custom prime with red cells was done.After noticing the blood in the saline bag, the nurse contact terumo bct customer support for assistance.Terumo bct customer support asked the customer to close the return saline roller, however, the nurse reported that the blue clamp on the return line not opened because "the system never prompted to either open the clamp or to close the return saline roller." the customer disconnected with tbct customer support indicating that they were discontinuing the procedure as the patient coded.Upon follow up, it was reported that the patient was treated by the pediatric intensive care unit (picu) with a transfusion of 120 ml of red cells and epinephrine and is stable.The customer declined to provide additional procedural details for this event.The customer declined to provide the patient identifier.Terumo bct is awaiting return of the disposable set.

Manufacturer Narrative

This report is being filed to provide additional information in h.10.Investigation: per the customer and the terumo bct service represtative, the extracorporeal volume (ecv) 297 ml + 40 ml of blood warmer tubing = 337 ml.In this case, approximately 337 ml of saline was used to prime the set.The saline bag should have 663 ml left after priming since the bag is 1000 ml.The rdf also shows that the return pump had returned 415 ml.Therefore, the patient not only did not receive the benefit of custom prime rbcs due to the clamping error, she lost 456 ml of whole blood (489 ml/15 x 14) due to the inability to perform rinseback.Based on the information provided, the patient lost approximately 78% of her total blood volume: (456 ml/586 x 100%).Investigation is in process.A follow up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information in b.5, h.6 and h.10.Investigation: given that the system pulled 489 ml from the patient in the 38 minutes of the procedure, and no fluid was returned to the patient within that time due to the return clamp being closed; the final fluid balance was calculated to be 26%.[(660 - 489)/660 = 26%] analysis of the photograph provided by the customer of the 1000 ml saline bag shows approximately 400 ml of rbcs settled at the bottom of the bag and 800 ml of saline on top, totaling a volume of 1200 ml.Correction: at the time of the initial customer call during the event, the clinical specialist explained to the operator that she did not receive a return pressure high alarm, even though the return clamp was closed, because the blood still had a clear pathway in the saline line since the roller clamp was open.The clinical specialist stressed the importance of following the screen prompts.The operator confirmed that she understood the information.Investigation is in process.A follow up report will be provided.

Event Description

The disposables set is not available from the customer as it was discarded.

Manufacturer Narrative

This report is being filed to provide additional information in h.1, h.6 and h.10.Investigation: the run data file (rdf) was analyzed for this event.Review of the run data file by a terumo bct field performance engineer indicated the following: the issues experienced in this procedure were due to the saline roller clamp remaining open when it should have been closed.The operator verbally confirmed that the clamp was still open.The files show that the correct prompt screens were displayed to the operator and the operator continued through them.One, "interface took too long to establish" alarm occurred 35 minutes into this procedure.The aim images were clean and clear and showed no signs of clumping.The procedure ran for 38 minutes.The pumps operated as designed and the pressures in the set were within the normal range.The device operated as intended.Calc tbv: 586 ml operator tbv: 660: ml fluid balance: 100% (1 ml) ac to patient: 35 ml custom prime was performed: 225 ml inlet flow rate: 15.98 ml/min inlet:ac ratio: 15:1 max ac infusion rate: 1.5 ml/min/l tbv rinseback was not performed a customer history search for 2 years prior to the incident date found no other similar reported issues.The device history record (dhr) was reviewed for this lot.There were no issues noted in the dhr that would have contributed to the error leading to hypovolemia as experienced by the customer.Investigation is in process.A follow up report will be provided.

Manufacturer Narrative

This report is being filed to provide information in h.10 investigation: the following are clarifying statements, final and corrected calculations, and additional information.In the photo of the 1l saline bag provided by the customer, the photo shows the bag is filled with approximately 1100 ml of fluid: most likely a mixture of custom prime rbcs, custom prime additive solution, saline, and possibly, the patient's rbcs as well.Approximately 400ml of the patient's blood was settled at the bottom of the bag.The dlog shows that from start to finish, the procedure ran for 38 minutes and the inlet pump drew in 489 ml at a 15:1 ac ratio.The entered patient's calculated tbv was 586 ml and the hct was 34%.The entered patient's calculated tbv was 660 ml and the hct was 34%.As a result of the return pinch clamp being closed, the device pulled 489 ml of the patient's blood and ac and diverted a mixture of the custom prime rbcs along with the patient's blood into the saline bag.The saline prime volume was 275 ml according to the dlog, so the 1000 ml saline bag should have 725 ml left after priming.The volume of blood being pumped into the saline can be estimated as follows: volume of blood pumped into saline bag = 1100 ml - 725 ml = 375 ml (this is in line with the estimate based on the photograph submitted by the customer.) the dlog also shows that the return pump had returned 415 ml, which is consistent with the estimated value stated in the previous supplement.Therefore, not only did the patient fail to benefit from the custom prime rbcs due to the clamping error, she lost 455 ml of whole blood (489 x 14/15) due to the inability to perform rinseback.Based on the information provided, the patient lost approximately 70% of her total blood volume: (455/660 x 100%).Investigation is in process.A follow up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h10.Root cause: based on the analysis of the run data file, as well as the clinical and investigation findings, the root cause of the blood in the saline bag was a failure of the operator to follow optia screen prompts to close the return saline roller clamp and open the return line clamp.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA IDL SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 9526434
• MDR Text Key: 186735402
• Report Number: 1722028-2019-00449
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583103108
• UDI-Public: 05020583103108
• Combination Product (y/n): N
• PMA/PMN Number: K183081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/27/2019

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: 10/01/2021
• Device Model Number: 10310
• Device Catalogue Number: 10310
• Device Lot Number: 1910253130
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 12/05/2019
• Initial Date FDA Received: 12/27/2019
• Supplement Dates Manufacturer Received: 02/10/2020; 04/20/2020; 04/26/2020; 09/04/2020; 10/09/2020
• Supplement Dates FDA Received: 03/06/2020; 04/24/2020; 05/18/2020; 09/04/2020; 10/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 00015 MO
• Patient Weight: 8