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

Model Number 10310

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

Patient Problem Thrombosis/Thrombus (4440)

Event Date 01/01/2020

Event Type  Death  

Manufacturer Narrative

Lot number and expiry information are not available at this time.Article citation: afroz, t., saleh, a.Peripheral blood stem cell (pbsc) collection and cryopreservation in hematopoietic stem cell transplantation: a single center experience in, (b)(4).Vox sanguinis.2020.115:371 investigation is in process.A follow-up report will be provided.

Event Description

The abstract, "peripheral blood stem cell (pbsc) collection and cryopreservation in hematopoietic stem cell transplantation: a single center experience in, bangladesh" it was reported one patient of allogeneic transplant died due to thrombotic complications.The abstract did not provide specific details, including patient information, outcome, or if any medical intervention was required, therefore, this report is being filed as a summary of events.It is unknown which of the patients died.The disposable set is not available for return because it was discarded by the customer.This report is being filed due to patient death, though at this time, 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 b5, e1, h6 and h10.Investigation : according to the article: aims: to assess the clinical outcome in patients of different hematological malignancies treated with hsct in bangladesh.Methods: 22 procedures in 15 patients and 3 donors (male 61.1%, female 38.9%, 15-71 years range) were carried out from march 2016 to january 2020 at a tertiary care hospital in bangladesh.For allogeneic transplantation a human leukocyte antigen (hla) compatible donor was selected.The criterion for optimal pbsc collection was the target number of 2-5 x 106 cd34+ cells/kg of patient's body weight.Cells were harvested on 5th day of mobilization using the spectra optia continuous flow blood cell separator (terumo bct, usa) and cobe spectra (terumo bct, usa).The extra cellular volume (ecv) was from 190-285 ml.Venous access was established via either a peripheral vein or central venous catheter and the anticoagulant solution acd-a (terumo penpol private limited, india) was infused at a ratio of 1:12 to 1:15.Intravenous calcium was given during procedure.The collection rate was maintained at 0.7-0.9 ml/min.1.5-3.3 blood volumes were processed for a period of 4-6 hours.The leukocytapheresis products were cryopreserved using 100% dimethyl sulfoxide (dmso), plasma lyte solution and 5% human albumin in liquid nitrogen in a controlled - rate freezing process.Infusion of stem cells were done according to different protocols.Results: 15 autologous transplantations in multiple myeloma (6 patients), hodgkin's lymphoma (4 patients), non-hodgkin's lymphoma (4 patients) and acute myeloid leukemia (1 patient) and 3 allogeneic transplantations for acute myeloid leukemia with one major abo in compatible were done.Pre procedural circulating cd34+ cell count was minimum 26/l and maximum 243/l.3 patients needed multiple leukocytapheresis sessions and only one patient needed priming with packed red blood cells (prbc) before procedure due to ecv exceeding >15% of blood volume.The collection volume was from 188-315 ml.The final yield of cd34+ cells was between 1.6-17 x 106/kg body weight.Cryopreservation was done for 12 patients.Adverse events: no adverse effects were noticed during leukocytapheresis procedure and infusion of stem cells.Engraftment was noticed from day 9 to day 17 and early post engraftment period was uneventful for all patients.One patient of allogeneic transplant died due to thrombotic complications.Summary/conclusions: today worldwide hsct is an accepted therapy with different needs and priorities and bangladesh is also creating opportunities for successful hsct.Since the authors reported that no adverse events occurred during the collection procedures or the infusion of stem cells, engraftment was reported for all patients from day 9 to day 17, and the early post engraftment period was uneventful for all patients, it is assumed the death occurred at least 17 days after the infusion of stem cells.Literature review indicates hematological malignant disorders are associated with a perturbed hemostatic system, and patients are at risk of bleeding and thrombotic complications.Depending on leukemia type (acute myeloid leukemia [aml] or acute lymphoblastic leukemia [all]) and the associated disease treatment, the rate of thrombotic complication ranges from 2.1% to 12.1%.The pathogenesis of thromboembolic disease in leukemia is complex and multifactorial.The major determinants are: (1) prothrombotic factors produced by leukemic cells, including tf, cancer procoagulant (cp), and inflammatory cytokine; (2) therapeutic agents used; (3) infectious complications; and (4) comorbid thrombophilia.Therefore, a wide variety of clinical manifestations characterize patients with acute leukemia, including clotting alterations, ranging from localized venous or arterial thrombosis to disseminated intravascular coagulopathy (dic).[colombo r, gallipoli p, castelli r.Thrombosis and hemostatic abnormalities in hematological malignancies.Clin lymphoma myeloma leuk.2014 dec;14(6):441-50.] the customer did not provide the lot number pertaining to this event, therefore a device history record (dhr) search could not be conducted for this specific incident.All lots must meet acceptance criteria before release.Investigation is in process.A follow up report will be provided.

Event Description

After multiple follow-up attempts no additional information, including patient info and procedural details, is available.

Manufacturer Narrative

This report is being filed to provide investigation: per internal medical review and analysis, the device did not cause or contribute to this incident.Root cause: the specific cause of death could not be determined.Based on information provided in the abstract, as well as literature review, the most likely cause of death was the patient's disease progression or concurrent therapy.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA IDL SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 11436305
• MDR Text Key: 238397290
• Report Number: 1722028-2021-00096
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583103108
• UDI-Public: 05020583103108
• Combination Product (y/n): N
• PMA/PMN Number: BK150251
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup,Followup
• Report Date: 03/08/2021

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: 10310
• Device Catalogue Number: 10310
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 02/08/2021
• Initial Date FDA Received: 03/08/2021
• Supplement Dates Manufacturer Received: 05/06/2021; 05/17/2021
• Supplement Dates FDA Received: 05/12/2021; 05/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other