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

Model Number 12220

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bradycardia (1751); Cardiac Arrest (1762); Insufficient Information (4580)

Event Date 03/23/2022

Event Type  Death  

Manufacturer Narrative

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

Event Description

The customer reported that a patient underwent a therapeutic plasma exchange (tpe) procedure.The patient was to be discharged post procedure.The central venous catheter was removed.The patient expired about 5-6 hours after the procedure.No adverse events were noted during the procedure.The patient was alert and oriented x3 prior to the procedure.Patient age is not available at this time.The tpe set is not available for return because it was discarded by the customer.This report is being filed due to patient death, although per current information there is no detectable malfunction with the terumo bct device or allegation of a malfunction.

Manufacturer Narrative

This report is being filed to provide additional information in b.5, b.6 and h.6.Investigation is in process.A follow up report will be provided.

Event Description

The customer reported that a patient underwent a therapeutic plasma exchange (tpe) procedure.The patient was to be discharged post procedure.The central venous catheter was removed.He decompensated with chest tightness about 2 hours after line removal.Respiratory decompensation ~3 hours post-tpe & ~2 hours post-line removal.Cxr showed bilateral infiltrates with hypoxemia.Ultimately intubated.Died ~10 hours rs post-tpe due to bradycardia and cardiac arrest.Per the customer, the cause of death was bradycardia and cardiac arrest.No adverse events were noted during the procedure and the patient was reported as stable pre and post procedure.No autopsy was performed.The patient was alert and oriented x3 prior to the procedure and 10% calcium gluconate 1 gm was given during procedure.Patient age is not available at this time.The tpe set is not available for return because it was discarded by the customer.This report is being filed due to patient death, although per current information there is no detectable malfunction with the terumo bct device or allegation of a malfunction.

Event Description

The customer reported that a patient underwent a therapeutic plasma exchange (tpe) procedure.The patient was to be discharged post procedure.The central venous catheter was removed.He decompensated with chest tightness about 2 hours after line removal.Respiratory decompensation ~3 hours post-tpe & ~2 hours post-line removal.Cxr showed bilateral infiltrates with hypoxemia.Ultimately intubated.Died ~10 hour srs post-tpe due to bradycardia and cardiac arrest.Per the customer, the cause of death was bradycardia and cardiac arrest.No adverse events were noted during the procedure and the patient was reported as stable pre and post procedure.No autopsy was performed.The patient was alert and oriented x3 prior to the procedure and 10% calcium gluconate 1 gm was given during procedure.The tpe set is not available for return because it was discarded by the customer.This report is being filed due to patient death, although per current information there is no detectable malfunction with the terumo bct device or allegation of a malfunction.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.10.Investigation: the patient with a presenting diagnosis of myasthenia gravis passed away on (b)(6)following therapeutic plasma exchange (tpe) procedure.The patient received tpe treatment as he was in myasthenia gravis crisis.Cause of death was documented as bradycardia and cardiac arrest.The patient was described as stable pre and post procedure.He decompensated with chest tightness about 2 hours after line removal.10% calcium gluconate 1 gm was administered during the procedure.No autopsy was performed.The lab values and notes were provided as follows: the customer did not indicate if they suspected the device caused or contributed to the patient death.The customer declined to confirm who determined the cause of death.Clinical data summarised as follows: respiratory decompensation ~3 hrs post-tpe & ~2 hr post-line removal.Chest x-ray (cxr) showed bilateral infiltrates with hypoxemia.Ultimately intubated.Died ~10 hrs post-tpe due to bradycardia and cardiac arrest.2 blood draws (abg and h/h) 20/64 wbc 53k when decompensating.At the time of apheresis, his h/h was 15.3/46.4.That morning wbc 11k (lab data shows actual wbc 14.5).Note: both hct and wbc drastically increased compared to the morning values before the tpe procedure.Service call was carried out on (b)(6) 2022.Completed functional check out of spectra optia including startup test, post start test and autotest.Completed aims system checkout.The run data file (rdf) was analyzed for this event.Review of the dlog and aim images for the procedure confirmed that the run was uneventful with no alarms or events that might indicate a potential issue during the procedure.There were a couple ¿replacement fluid was not detected¿ alarm which is common and does not indicate any issue during the run.There were no other alarms generated for either procedure.Review of the aim images did not show any issues during the procedure.The system appeared to be operating as intended and there were no signals to indicate the device malfunctioned.A disposable complaint history search was performed for this lot and found one other report of patient death on this lot from the same customer site.See mdr 1722028-2022-00169.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

Investigation: the customer did not indicate if they suspected the device caused or contributed to the patient death.The customer declined to confirm who determined the cause of death.Clinical data summarised as follows: - respiratory decompensation ~3 hrs post-tpe & ~2 hr post-line removal.- chest x-ray (cxr) showed bilateral infiltrates with hypoxemia.Ultimately intubated.- died ~10 hrs post-tpe due to bradycardia and cardiac arrest.- 2 blood draws (abg and h/h) 20/64 wbc 53k when decompensating.- at the time of apheresis, his h/h was 15.3/46.4.That morning wbc 11k (lab data shows actual wbc 14.5).Note: both hct and wbc drastically increased compared to the morning values before the tpe procedure.Service call was carried out on 10 may 2022.Completed functional check out of spectra optia including startup test, post start test and autotest.Completed aims system checkout.The run data file (rdf) was analyzed for this event.Review of the rdf and aim images for the procedure confirmed that the run was uneventful with no alarms or events that might indicate a potential issue during the procedure.There were a couple ¿replacement fluid was not detected¿ alarm which is common and does not indicate any issue during the run.There were no other alarms generated for either procedure.Review of the aim images did not show any issues during the procedure.The system appeared to be operating as intended and there were no signals to indicate the device malfunctioned.A disposable complaint history search was performed for this lot and found one other report of patient death on this lot from the same customer site.See mdr 1722028-2022-00169.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Based on the clinical and investigation findings of this report, the spectra optia device and exchange set performed as intended, there were no suggested device failures, malfunctions, mislabeling, improper or inadequate design or manufacturing errors, nor was there any stated user errors that contributed to or caused the death of the patient in this report.The faulty seal safe would not have contributed to the patient death since the run data analysis confirmed that there were no alarms during this substate where spectra optia assesses the pressure in the inlet line to ensure that the patient line is clamped before rinseback and would have generated a prompt to clamp the inlet line if an abnormal pressure was detected.It is likely that the patient¿s death was likely related to their underlying medical condition since the patient was clinically stable at the time their tpe procedure was terminated.The requirement of calcium gluconate during the procedure is a standard therapeutic intervention during tpe for low ionized calcium levels.Terumo bct internal medical review determined that the device did not cause or contribute to the reported death.Root cause: based on the information from the clinical and investigational findings, the cause of the patient's death was likely due to the pre-existing disease condition.

Event Description

The customer reported that a patient underwent a therapeutic plasma exchange (tpe) procedure.The patient with a presenting diagnosis of myasthenia gravis and was in myasthenia gravis crisis.The patient was described as alert and oriented before the procedure with pre hgb = 15.3 g/dl, hct = 46.4 and wbc = 14,500/l.He was given 10% calcium gluconate 1 gm during the procedure as prophylaxis.The patient had left internal jugular catheter and it was flushed with 10 ml normal saline (twice) followed by 5 ml of heparin (twice) immediately right after the patient was disconnected from the device.The notes provided indicated that there were no adverse events observed up to this point.The patient was to be discharged post procedure.The central venous catheter was removed.He decompensated with chest tightness about 2 hours after line removal.Respiratory decompensation ~3 hours post-tpe & ~2 hours post-line removal.Cxr showed bilateral infiltrates with hypoxemia.Ultimately intubated.Died ~10 hours post-tpe due to bradycardia and cardiac arrest.Per the customer, the cause of death was bradycardia and cardiac arrest.No adverse events were noted during the procedure and the patient was reported as stable pre and post procedure.The last reported h/h and wbc were 20 g/dl / 64% and 53,000/l although the timing of these labs relative to the patient¿s decompensation is not known.No autopsy was performed.The patient was alert and oriented x3 prior to the procedure and 10% calcium gluconate 1 gm was given during procedure.The tpe set is not available for return because it was discarded by the customer.This report is being filed due to patient death, although per current information there is no detectable malfunction with the terumo bct device or allegation of a malfunction.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer (Section G): TERUMO BCT; 10810 w. collins ave; lakewood CO 80215
• Manufacturer Contact: scot hilden ; 10810 w. collins ave; lakewood, CO 80215
• MDR Report Key: 14517800
• MDR Text Key: 292785875
• Report Number: 1722028-2022-00170
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 35020583122209
• UDI-Public: 35020583122209
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK150251
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/26/2022

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: 01/01/2024
• Device Model Number: 12220
• Device Catalogue Number: 12220
• Device Lot Number: 2201263130
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/04/2022
• Initial Date FDA Received: 05/26/2022
• Supplement Dates Manufacturer Received: 06/10/2022; 11/11/2022; 01/05/2023
• Supplement Dates FDA Received: 06/20/2022; 12/06/2022; 01/17/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/26/2022
• 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 Age: 60 YR
• Patient Sex: Male
• Patient Weight: 80 KG