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

Catalog Number 12220

Device Problems Defective Device (2588); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypovolemic Shock (1917); Pulmonary Edema (2020)

Event Date 03/18/2021

Event Type  Death  

Manufacturer Narrative

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

Event Description

The customer reported that the patient with transverse thoracic myelitis underwent therapeutic plasma exchange (tpe) on (b)(6) 2021, (b)(6) 2021, (b)(6) 2021, (b)(6) 2021 (2x because the shaldon catheter did not work well at first), and 03/17/2021 (with human albumin 3%).The patient died on (b)(6) 2021 of hypovolemic shock and pulmonary edema of unclear origin that could not be controlled by intensive care medicine.The patient experienced an increase in the hemoglobin value with each treatment by 2.5 g / dl up to 4 g / dl, which the customer states could possibly be due to a misbalancing of the device with too much plasma withdrawal in relation to the substitution.The lot number of the last four kits is 2008043230.The lot number of the first two kits is no longer traceable, per the customer.The patient identifier and weight are not available at this time.This report is being filed due to a patient death, although there is not an allegation that the device caused or contributed to the event.The disposable set is not available for return because it was discarded by the customer.

Event Description

Pursuant to eu personal data protection laws, the patient identifier is not available from the customer.Patient weight was obtained from the rdf.

Manufacturer Narrative

Investigation : the run data file (rdf) was analyzed for the six runs reported by the customer.There were 6 procedures reviewed for this issue.Procedures 1, 2 and 3 seemed to run smoothly with very little alarms or issues.In procedure 4 the operator received several ¿patient fluid balance may be lower than reported¿ alarms.These alarms eventually caused the procedure to receive the run ending alarm ¿patient's fluid balance may be 15% lower than reported¿.Further review of the procedure showed that the accumulated reservoir error was around 715ml when the procedure was ended.The total replace volume for the run was 797ml.It is possible that the replacement fluid was not properly flowing back the reservoir and not making it back to the patient.Other potential causes for this alarm include but are not limited to: 1) an occlusion in the replace line 2) variation in pump stroke volume 3) an occlusion in the inlet line causing less fluid into the system the machine operated as intended and alarmed multiple times notifying the operator that the patients fluid balance may be lower than reported.However, the issue appeared to continue until the system ended the procedure due to the error accumulated in the reservoir reaching the run ending value of 15%.Procedure 5 had multiple ¿aim system detected rbc interface near top of channel¿.This alarm typically occurs if the hematocrit entered by the operator is too low.In this procedure the alarms did not start occurring until 63 minutes into the procedure.The alarms then stopped when the operator increased the entered patient hct.The final procedure did not show any issues.The system appeared to be operating as intended and there were no signals to indicate the device malfunctioned.A service was completed for the device on 27 april 2021, a saline run was performed, and no issues were noted.All tests passed.The device was verified to be operating per manufacturer specifications.The disposable lot query was performed for lot 2008043230 and no similar reported occurrences were received against this lot to date.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.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.10 and corrected information in b.3.Investigation: the customer did not suspect device malfunction caused or contributed to the patient's death.According to the customer, the cause of death was attributed to treatment resistant pulmonary edema via autopsy.The autopsy and the lab/clinical data was requested but the customer declined to provide the information after consulting with their legal department.Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information in b.6 and h.10.Investigation: during a follow up phone call with the treating physician, terumo bct therapeutic specialty sales consultant indicated that "he did mention on the phone, that he felt that the death did not have anything to do with our device, but rather several compounding factors, such as 1) the patient¿s health and 2) the use of 3% albumin ¿ which has been standard % at the hospital since a very long time.He said the 3% was a standard that was not challenged.There is now a task force that is re-evaluating this sop and will be / has changed it to 5% / along with consideration of which additional replacement solutions to be used- depending upon the indication.Furthermore, 3) they are re-evaluating their diagnostics for such patients." the customer initially suspected that the device caused the patient's death but determined that there was no device malfunction after the technical review.The customer declined to provide the autopsy and the lab/clinical data due to the customer's legal privacy requirements.The dlog confirmed that the customer had selected custom replacement fluid type and entered citrate concentration as zero.The hct entered and any adjustments made during the procedures were obtained from the dlog, and the positions of rbc were verified using aims images.Date patient's hct entered patient's hct re-entered (b)(6) 40% no adjustment (b)(6) 40% no adjustment (b)(6) 43% no adjustment (b)(6) 42% no adjustment (b)(6) 42% 45% (b)(6) 49% no adjustment it appears the patient's hct had increased from 40% on (b)(6) to 49% on (b)(6), over a course of 6 days.The aims images and dlog ruled out the possibility of sampling and laboratory errors.Date total replace used total plasma removed plasma volumes exchanged 3/12 2889 ml 2935 ml 1.0 3/13 4016 ml 4089 ml 1.4 3/15 4097 ml 4179 ml 1.5 3/16 797 ml 856 ml 0.3 3/16 3720 ml 4720 ml 1.5 3/17 4000 ml 4028 ml 1.6 date target fb (%) final fb (%) (b)(6) 104% (+200ml) 105% (+227 ml) (b)(6) 104% (+200ml) 104% (+214 ml) (b)(6) 104% (+200ml) 104% (+212 ml) (b)(6) 104% (+200ml) 102% (+102 ml) (b)(6) 104% (+200ml) 104% (+225 ml) (b)(6) 104% (+200ml) 104% (+224 ml) the plasma volumes exchanged ranged from 1.0 to 1.6 tbv with the exception of procedure no.4, which was terminated after 0.3 tbv was exchanged.The final fluid balance for all six procedures were well within the target values, including procedure no.4 where the run was prematurely terminated as a result of the level sensor alarms by safety.In the 5th procedure, 'aim system detected rbc interface near top of channel' alarms were activated several times during the procedure indicating the possibility of fluid shifts resulting in high rbc levels.The last (6th) procedure ended at 19:04 on march 17.At an unspecified time on the following day, the patient went into hypovolemic shock , 'pulmonary edema of unclear origin which could not be controlled by intensive care medicine' according to the customer.The patient subsequently died.Malfunction rationale: based on the dlog analysis and aims images, there is no evidence of fluid imbalance and plasma volume contraction after the procedure.Aims images confirmed that the interface was set up in the correct position based on the hct values or adjustments entered by the operator, hence ruling out sampling or laboratory errors.Terumo bct medical safety concluded that, based on the clinical and investigation findings, the spectra optia device performed as intended, there were no suggested device failures, malfunctions, mislabeling, improper or inadequate design or manufacturing errors, nor was there any reported user errors that contributed to or caused this adverse event.The cause of death, as determined by the treating physician, was likely the result of several factors, including treatment-resistant pulmonary edema.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 h.1 and corrected information in b.3.Root cause: based on the physician's statements, supported by the clinical findings, rdf analysis, the service performed on the device, the cause of the patient's death was due to several compounding factors including treatment-resistant pulmonary edema.The root cause of the hypovolemic shock and pulmonary edema could not be definitively determined from the limited clinical information received.Potential contributing factors include use of a hypo-oncotic replacement fluid, depletion of coagulation factors leading to hemorrhage, other alterations in patient¿s fluid status, or underlying comorbidities.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 11648801
• MDR Text Key: 244893543
• Report Number: 1722028-2021-00149
• 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: foreign,health professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/12/2021

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: 08/01/2022
• Device Catalogue Number: 12220
• Device Lot Number: 2008043230
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 03/19/2021
• Initial Date FDA Received: 04/12/2021
• Supplement Dates Manufacturer Received: 04/30/2021; 06/01/2021; 07/07/2021; 07/09/2021
• Supplement Dates FDA Received: 05/04/2021; 06/16/2021; 07/08/2021; 07/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 79