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

Catalog Number 10220

Device Problems Excess Flow or Over-Infusion (1311); Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

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

Event Date 07/30/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation: per physician's order at the customer site, fresh frozen plasma (ffp) was used as the replacement fluid with target fb (fluid balance) of 85% and reported ending fb of 85% ( -149 ml).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 a pediatric patient with thrombocytopenia- associated multiple organ failure (tamof) and multi system organ failure was undergoing a therapeutic plasma exchange (tpe) procedure on optia.After completing a blood prime, they noticed that there was approximately 100 mls of blood still left in the blood bag and also discovered saline bag with approximately 200 mls of less normal saline(ns).Initially the customer contacted terumo bct to perform another blood prime and stated that inadvertently she left the inlet saline roller clamp opened.The tbct customer support suggested the operator that in order to perform a blood prime she needs to stop priming the blood before it finishes off and when system message about the 'volume not being enough to prime the ecv' and then to follow the option of continuing.Per the customer, they continued with the remaining blood.Per physician's order, dated (b)(6) 2019 at 15:10 hct% was performed at bedside of the patient by ecox machine and found at 27% and ordered a unit of blood to be transfused to the patient.After transfusion, the hct was found at 35.2% with next day reported as 35.3%.Per the customer, the patient is reported in 'stable' condition.The customer declined to provide patient id.The exchange set is not available for return because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provide updated information.Updated investigation: custom prime fills the tubing set with a specified fluid (rbcs, plasma, albumin) after priming the set with saline and before connecting the patient.When treating a patient with a low rbc volume or a low blood volume, such as a pediatric patient, this option is provided to maintain isovolemia.Per the spectra optia operator's manual, a custom prime volume of 200ml is recommended for exchange sets, plus the volume of any blood warmer tubing on the return line; however, a recommendation for the hematocrit of priming blood is not provided.Since there is a greater potential for change in a patient¿s hematocrit after a blood prime if the patient has a low tbv and a low hematocrit, using priming blood with low hematocrit can result in a decrease in hematocrit in small patients.When the operator called terumo bct customer support, the system had completed custom prime; however, there was 100ml of the priming blood left in the bag due to the saline which had entered the system.Since they had prepared 325ml for custom prime, it is assumed that the operator entered this volume into the system prior to priming as the original fluid volume.To use the remaining priming blood, the terumo bct clinical specialist advised the operator to extend the custom prime and instructed them to enter the sum of the original fluid volume (325ml) plus the volume of the additional fluid (100ml).The patient in this event had a total blood volume (tbv) of 250 ml and a pre-hematocrit 32.9%.As the custom prime blood initially prepared for this procedure was inadvertently diluted with approximately 200ml of saline, the final hematocrit of the priming blood was calculated to be 36%.The hematocrit of the final custom blood prime was calculated based on the following: 325ml of blood at hematocrit 59% was initially prepared for custom prime 100ml of blood was remaining at the time the inlet saline clamp was closed 200ml of saline had entered the system (beyond the amount used to saline prime).The total volume of the initial custom prime was 425ml (200ml of saline + 225ml of prime blood) hematocrit of initial prime = (59% x 225ml)/425ml = 31% hematocrit of final prime = ((59% x 100ml) + (31% x 425ml))/525 = 36% investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

This report is being filed to provide updated information in mfr site and report source.Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information in investigation: based on the information provided by the operator regarding the fluid balanceand the ac to patient, as well as the lack of alarms related fluid balance and reservoir level sensors,the machine operated as intended.Investigation is in process.A follow up report will be provided.

Manufacturer Narrative

This report is being filed to provide in investigation: custom prime fills the tubing set with a specified fluid (rbcs, plasma, albumin)after priming the set with saline and before connecting the patient.When treating a patient witha low rbc volume or a low blood volume, such as a pediatric patient, this option is provided tomaintain isovolemia.Per the spectra optia operator's manual, a custom prime volume of 200ml is recommended forexchange sets, plus the volume of any blood warmer tubing on the return line; however, arecommendation for the hematocrit of priming blood is not provided.Since there is a greater potential for change in a patient¿s hct after a blood prime if the patienthas a low tbv and a low hct, using priming blood with low hct can result in a decrease inhematocrit in small patients.The patient in this event had a total blood volume (tbv) of 250 ml and a pre hematocrit of32.9%.As the custom prime blood initially prepared for this procedure was inadvertently dilutedwith approximately 200ml of saline, the hct of the priming blood was calculated to be 31%.The hct of the custom blood prime was calculated based on the following: - 325ml of blood athct 59% was initially prepared for custom prime- 100ml of blood was remaining at the time the clamp was closed- 200ml of saline had entered the system- approximately 425ml of fluid was used for custom prime, including 100ml of 59% hct blood and200ml of saline, resulting in a custom prime of approximately 20% hct [(59% x 225ml)/425ml =31%].Correction: at the time of the call on 30 jul 2019, the operator had realized her error duringcustom prime and understood the importance of closing the saline roller clamp.Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information in h.10.According to the tpe flow sheet provided by the customer, the procedure started at 12:47 and ended at 13:46 with a total run time of 59 minutes.Assuming a minimum inlet flow rate of 10 ml/min, the total inlet volume processed is estimated to be 590 ml or roughly two times the patient's tbv.In this scenario, it would be reasonable to assume that the rbcs from the custom prime and the patient had been adequately mixed, and the hematocrit in the set remained consistent over the course of the procedure.The extracorporeal volume (ecv) for an exchange set is approximately 200 ml with an additional 40 ml for blood warmer tubing.This would require approximately 81 ml of packed red cells, which represents 98% of the patient's circulating rbcs.Rbcs in ecv from diluted custom prime = 240 ml x 36.5% hct = 87.6 ml patient's total packed rbcs before the procedure = 250 ml x 32.9% hct = 82.25 ml total rbcs in patient and in ecv = 82.25 ml + 87.6 ml= 169.85 ml total volume of blood in patient and in ecv = 240 ml + 250 ml = 490 ml estimated hct (in patient and extracorporeal volume) = 170 ml/490 ml x 100 = 35% based on the available information, and the lab draw @ 1304, which indicated that the patient's hct was 33% during the run, it is unlikely that the open inlet saline roller clamp contributed to the drop in the patient's hematocrit.Since the system has an imposed tbv limit of 300 ml, and it would not permit programming any values less than 300 ml; it is reasonable to assume that the operator had entered the minimum value in order to proceed.The physician had ordered a final fluid balance of 85% and according to the run summary flow sheet, the customer did not perform rinseback.Based on these assumptions, the system would have to remove 45ml of plasma in order to keep a final fluid balance of 85%.The patient received 70 ml of calcium, which was not factored in the overall fluid balance.The patient final tbv with calcium is calculated as follows: final tbv = 250 ml - 45 ml +70 = 275 ml investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

Investigation: a disposable history search for this lot found no other reports of similar issues.Final tbv = 250 ml - 45 ml +70 = 275 ml, resulting in a final fluid balance of 91% investigation is in process.A follow up report will be provided.

Manufacturer Narrative

Investigation: terumo bct medical review concluded the cause of the decrease in patient hematocrit is unknown, with the most likely cause being the patient's medical condition.Per the article in transfusion medicine, 2019, 29, 231¿238, 'approaches to understanding and interpreting the risks of red blood cell transfusion in neonates' by a.K.Keir et.Al, in neonatal units, rbc transfusions are most often undertaken to manage aop.Aop (apnea of prematurity) is a multifactorial condition defined by early, significant anemia in the context of phlebotomy blood losses, lower erythropoietin (epo) production, and limited bone marrow response.Terumo bct medical review concluded the operator error in leaving the saline inlet line roller clamp open did not result in a decrease in the patient hematocrit during the procedure, and the optia system performed as expected during the run.The cause of the decrease in patient hematocrit measured in a patient blood sample taken about 90 minutes after the procedure is unknown, and there is no evidence to suggest that the optia caused or contributed to this outcome.Root cause: based on the customer statements and clinical findings, the root cause of the custom prime issue was the operator's failure to follow the screen prompt to close the inlet saline roller clamp at the end of prime divert.The cause of the patient's drop in hct is undetermined.Possible root causes include, but are not limited to, the patient's underlying disease state.Citation: keir, a.K., new, h., robitaille, n., crighton, g.L., wood, e.M., & stanworth, s.J.(2019).Approaches to understanding and interpreting the risks of red blood cell transfusion in neonates.Transfusion medicine, 29(4), 231-238.Https://doi.Org/10.1111/tme.12575.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 8926250
• MDR Text Key: 165049118
• Report Number: 1722028-2019-00241
• Device Sequence Number: 1
• Product Code: LKN
• 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: 08/23/2019

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: 06/01/2021
• Device Catalogue Number: 10220
• Device Lot Number: 1906043230
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 07/30/2019
• Initial Date FDA Received: 08/23/2019
• Supplement Dates Manufacturer Received: 09/10/2019; 09/23/2019; 10/11/2019; 12/18/2019; 01/23/2020; 03/05/2020; 04/07/2020
• Supplement Dates FDA Received: 09/17/2019; 10/11/2019; 11/05/2019; 12/19/2019; 01/31/2020; 03/17/2020; 04/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 00007 DA
• Patient Weight: 3