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

Model Number 10310

Device Problem Insufficient Information (3190)

Patient Problems Bacterial Infection (1735); Hemorrhage/Bleeding (1888); Sepsis (2067); Fungal Infection (2419)

Event Date 12/15/2020

Event Type  Injury  

Manufacturer Narrative

Lot number and expiry are not available at this time.Article citation: kumar, s.Et.Al.2022.Long-term outcomes and safety trends of autologous stem-cell transplantation in non-hodgkin lymphoma: a report from a tertiary care center in india.Stem cell and cellular therapies.Doi https://doi.Org/10.1200/go.21.00383 investigation is in process.A follow up report will be provided.

Event Description

The journal article, 'long-term outcomes and safety trends of autologous stem-cell transplantation in non-hodgkin lymphoma: a report from a tertiary care center in india', describes a study on autologous stem-cell transplantation (asct) in non-hodgkin lymphoma (nhl) adult patients autografted between january 1, 2002, and december 15, 2020.Per the article, all patients developed febrile neutropenia at a median of 4 after transplant.Microbiological evidence of infection was available in 26 (32.5%) patients overall: gram-negative bacteria in 17 (21.2%), gram-positive isolates in six (7.5%), and mixed organism growth in three (3.7%) patients.A median of 5 (iqr, 2-8) antibiotics were used for a duration of 13 days (median, 7-37) days.Forty-four (55.0%) patients required therapeutic antifungals beginning on day 8 (median, iqr 5- 13) and amphotericin b was most commonly used (54.5%).Patients in group b used fewer numbers (4 v 5, p =.004) and durations (11 v 16 days, p =.01) of antibiotics, but therapeutic antifungal use was not different among the study groups.The most common grade 3 or 4 regimen-related toxicities were mucositis, diarrhea and vomiting.Overall, nine (11.2%) patients died within 100 days after transplantation; sepsis was the cause in seven (8.7%) patients, followed by pulmonary alveolar hemorrhage in two (2.5%).The median age at transplant was 38 (interquartile range [iqr], 22-60) years; the male to female ratio was 4:1.Further details about patients were not provided in the article, therefore this report is being submitted as a summary of events.The apheresis sets are not available for return for evaluation.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA IDL 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: 16131508
• MDR Text Key: 307011106
• Report Number: 1722028-2023-00010
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583103108
• UDI-Public: 05020583103108
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: BK150251
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/10/2023

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 Model Number: 10310
• Device Catalogue Number: 10310
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/21/2022
• Initial Date FDA Received: 01/10/2023
• Was Device Evaluated by Manufacturer?: No
• 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