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

Catalog Number 10116

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

Patient Problems Fever (1858); Dizziness (2194); Confusion/ Disorientation (2553)

Event Date 11/05/2020

Event Type  Death  

Manufacturer Narrative

Investigation: the disposable lot query was performed for lot 1812043231 and no similar reported occurrences were received against this lot to date.The device history record (dhr) was reviewed for this lot.There were no issues identified that would have caused or contributed to the patient death.All quality labs and sterilization requirements passed.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported the death of a patient diagnosed with hemophagocytic syndrome after receiving two allogenic hematopoietic stem cell transfusions.On (b)(6) 2020, the first allogenic collection was performed on a healthy donor, on device (b)(4) and no issues were reported.10080 ml whole blood volume was processed, run time was 254 minutes and the collect volume was 276 ml.Total ac used was 782 ml and 756 ml ac went to the donor.On (b)(6) 2020 at 15:35, 260 ml stem cells were infused to the patient from the product bag.The patient's temperature was measured twice: upon infusion to be 36.9 degrees celsius and 38 degrees celsius recorded at 18:00.On (b)(6), the second allogenic collection was performed on a healthy donor, on device (b)(4) and no issues were reported.7623 ml whole blood volume was processed, run time was 216 minutes and the collect volume was 306 ml.Total ac used 625 ml and 595 ml ac went to the donor.On (b)(6) 2020 at 20:35, 163 ml stem cells were infused to the patient from the product bag.The patient's body temperature was recorded on five occasions and additional symptoms recorded: 06:00: 38.7 degrees celsius.10:00: 39.8 degrees celsius, dizziness and irritability.14:00: 39.5 degrees celsius.14:20: patient felt sleepy but still able to respond.15:00: patients blood pressure decreased.18:00: 40.5 degrees celsius, disturbance of consciousness.20:35: 163 ml stem cells were infused to the patient from the product bag.21:00: 39.4 degrees celsius.On (b)(6) 2020, per the customer, "all kinds" of symptomatic treatments were carried out at hospital.On (b)(6) at 11:58 am, the patient died.Patient weight is not available at this time.The disposable set is not available for return because it was discarded by the customer.This product is not available within the us, but this report is being filed due to an alleged failure that could occur on a similarly marketed device platform cleared for use by the fda.This report is being filed due to patient death, though there is no allegation that the device caused or contributed to the patient death.

Manufacturer Narrative

This report is being filed to provide additional information in a.4, b.5., b.6, e.1, e.3, and h.10.Investigation: the run data files were analyzed for both procedures.Review of the rdf and aim images for the two mnc procedures on (b)(6) 2020 confirmed that the runs were uneventful with no alarms or events that might indicate a potential issue during the collections.There were four access pressure alarms on the (b)(6) run likely related to the patient access and the inlet flow rate being set too high.There was also a centrifuge door not closed properly alarm at the start of the (b)(6) run.There were no other alarms generated for either procedure.Review of the aim images for both procedures did show some buffy coat accumulation throughout the run which is expected due to effective mobilization of the patient evidenced by high white blood cell and platelet counts.Both procedures met the targeted values and performed successful rinseback to the patient.Investigation is in process.A follow up report will be provided.

Event Description

Patient weight was obtained from the run data file.The customer declined to provide further information regarding cause of death or autopsy report.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.10.Investigation: transfusion of the collected product to the recipient patient took place within 24 hours of each spectra optia procedure.It is assumed that no product freezing was involved.Service was performed on both devices on (b)(6) 2020.Visual inspection found no damage and all grounding was secured and resistance was normal.A pressure check on all pressure transducers confirmed all were 100% functional and within manufacturer specifications.A leakage current test and an autotest were completed.All tests passed.The device was verified to be operating per manufacturer specifications.Per internal medical review and analysis, the device did not cause or contribute to this incident.Investigation is in process.A follow up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information in e.1, h.6 and h.10.Root cause: review of the dlog and aim images for the two mnc procedures on (b)(6) 2020 confirmed that the runs were uneventful with no alarms or events that might indicate a potential issue during the collections.There were four access pressure alarms on the 2 nov run likely related to the donor's access and the inlet flow rate being set too high.There was also a centrifuge door not closed properly alarm at the start of the (b)(6) run.There were no other alarms generated for either procedure.Review of the aim images for both procedures did show some buffy coat accumulation throughout the run which is expected due to effective mobilization of the donor evidenced by high white blood cell and platelet counts.Both procedures met the targeted values and performed successful rinseback to the donor.Based on the clinical findings, the run data file analysis and the service performed on the two devices, there is no evidence to indicate that the disposable tubing set or optia device caused or contributed to the patient's death.Hlh is an aggressive immune-mediated disorder that destroys tissues in multiple organs.High fevers occur in most cases as do cytopenias.Hlh is a rare disease most often seen in its primary (genetic) form in pediatric patients but secondary (acquired) forms can also be triggered by or accompanied by bacterial or viral infections and hematological cancers.Mortality is high, particularly among patients with advanced disease, which was likely the case for this patient who was being treated with allogeneic hpc transplantation.The very low likelihood that the patient became febrile due to bacterial contamination of the infused hpc and the apparent absence of a system failure or malfunction, manufacturing issues, improper or inadequate design, labeling error, or user error, and the presence of multiple symptoms related to hlh strongly points to the patient¿s underlying condition/pathologies as the likely cause of death.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA COLLECT SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 10949615
• MDR Text Key: 219865202
• Report Number: 1722028-2020-00532
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/04/2020

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: 12/01/2020
• Device Catalogue Number: 10116
• Device Lot Number: 1812043231
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 11/12/2020
• Initial Date FDA Received: 12/04/2020
• Supplement Dates Manufacturer Received: 12/08/2020; 12/30/2020; 01/20/2021
• Supplement Dates FDA Received: 12/28/2020; 01/19/2021; 02/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 00022 YR
• Patient Weight: 52