MAUDE Adverse Event Report: TERUMO BCT SPECTRA OPTIA; SPECTRA OPTIA APHERESIS SYSTEM

Model Number 61000

Device Problems Use of Device Problem (1670); Inaccurate Delivery (2339); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Overdose (1988); No Known Impact Or Consequence To Patient (2692)

Event Date 11/11/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported that a patient received more anticoagulant citrate dextrose solution a (acd-a) during a therapeutic plasma exchange (tpe) on a spectra optia device thank expected.Per the customer, 33 mls more of acd-a was used on the procedure than had been used a few days prior on the same patient during the procedure.Following a conference call between the patient's doctor and the customer, it was noted that the patient's actual weight was entered on (b)(6) 2019, which was higher on this day due to having excess body fluid.Per the customer the patient also receives dialysis.Patient information and outcome are unknown at this time.The disposable set is not available for return because it was discarded by the customer.

Event Description

After multiple follow-up attempts, the customer did not provide further procedural details for this event, including if medical intervention was required.

Manufacturer Narrative

This report is being filed to provide additional information in and corrected information in e.3.Investigation: per the customer, the solutions were connected to the proper lines.Additional evaluation of the rdf indicates that the risks of an increased (ac) infusion rate is that the patient's ionized calcium would decrease more rapidly than expected due to the increased amount of citrate binding to the circulating calcium ions.For example, most patients tolerate an infusion rate of 1.2 ml acd-a/ltbv/min for 60 minutes before experiencing mild symptoms of hypocalcemia due to decreases in ionized calcium of about 20%.However, at an infusion rate of 1.75 ml acd-a/ltbv/min, it takes only about 10-15 minutes to cause a 20% decrease in ionized calcium.To calculate an individualized "citrate dose" for each patient, the optia system multiplies the configured maximum ac infusion rate times the patient¿s total blood volume.This calculation determines the rate at which ac (citrate) will be infused to the patient each minute.For the procedure on (b)(6) 2019 the optia system calculated a tbv of 3.833l based on the entered body weight including excess fluid.The estimated citrate dose was calculated to be 3.1 ml/min, assuming a maximum ac infusion rate setting of 1.2 ml/min/ltbv: 1.2 ml/min/ltbv x 3.833l tbv = 4.6 ml/min the customer stated that the patient's tbv using ideal body weight (estimated to be 58 kg) was 3702 ml.See attachment in salesforce.The adjusted citrate dose was recalculated using the tbv based on the actual weight, which was determined to be 3.0 ml/min/ltbv: 1.2 ml/min/ltbv x 3.702 l tbv = 4.4 ml/min based on these calculations, the difference in citrate doses is negligible.Root cause: the specific root cause of the additional ac to the patient was undetermined.Possible causes include, but are not limited to: an incorrect entry of the patient's weight - changes to the inlet pump flow rate during the procedure - running the procedure in algorithm control.

Manufacturer Narrative

This report is being filed to provide additional information in b.5, h.6, and h.10.Investigation: one year of service history was reviewed for this device with no issues related to the reported condition identified.The device serial number history report indicates no further related issues have been reported for this device.A customer history search was performed with no other reports of similar issues found.The run data file (rdf) was analyzed for this event.Analysis indicated the following: since the ac infusion rate is based on the patient's tbv, which the system calculates based on the entered height, weight, and gender of the patient.Therefore, a difference in patient weight will impact the amount of ac the patient receives: the larger the weight, the more ac the patient will receive and vice versa.The operator also decreased the inlet flow rate from 75 ml/min to 31 ml/min at 51 minutes into the procedure and this extended the procedure time from 68 minutes to 104 minutes.The longer the procedure runs, the more ac the patient will receive as well.This was probably a larger contributor to the additional 33 ml of ac returned to the patient.The aim images were clean and clear and showed no signs of clumping.The pumps operated as intended and the pressures in the set were within the normal operating range.There were not any alarms that occurred during this procedure.The device operated as intended.Tbv: 3833 ml fluid balance: 100% saline to patient: 135 ml ac to patient: 78 ml saline/albumin replace used: 2047 ml rinseback was completed the customer stated that the patient's tbv using ideal body weight (estimated to be 58 kg) was 3702 ml.For the procedure on (b)(6) 2019 the optia system calculated a tbv of 3.833l based on the entered body weight including excess fluid (62kg), the estimated ac infusion rate is calculated to be 0.20 ml/min/ltbv: 78 ml of ac/104min/3.833l = 0.20 ml/min/ltbv the adjusted ac infusion rate can be recalculated using the tbv calculated based on the actual weight, which was determined to be 0.20 ml/min/ltbv as well: 78 ml of ac/104min/3.702l = 0.20 ml/min/ltbv based on these calculations, the difference in ac infusion rates is negligible and an ac infusion rate of 0.2 is well below the default ac infusion rate of 0.8 ml/min/ltbv for tpe procedures.While the length of the first procedure (using the patient's actual weight) is unknown, the calculations support the suggestion that the change to the inlet flow rate, which added time to the procedure on november 11, largely contributed to the additional 33 ml of ac to be infused to the patient.Investigation is in process.A follow up report will be provided.

Event Description

The customer declined to provide patient information.Patient weight and gender were obtained from the run data file.The customer reported the patient as stable.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA APHERESIS SYSTEM
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 9540407
• MDR Text Key: 186735383
• Report Number: 1722028-2020-00004
• Device Sequence Number: 1
• Product Code: LKN
• UDI-Device Identifier: 05020583610002
• UDI-Public: 05020583610002
• Combination Product (y/n): N
• PMA/PMN Number: K153601
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/02/2020

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 Model Number: 61000
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 12/10/2019
• Initial Date FDA Received: 01/02/2020
• Supplement Dates Manufacturer Received: 02/10/2020; 02/26/2020
• Supplement Dates FDA Received: 02/14/2020; 03/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 62