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

Model Number 10310

Device Problems Microbial Contamination of Device (2303); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2020

Event Type  malfunction  

Manufacturer Narrative

Lot number and expiry information are not available at this time.Article citation: coronel, m.L.P., velao, s.R., cedena, m.T., aldea, a.L., valeri, a., garcía, a., velazquez, b.A., lozano, d.S., arce, e.G., lópez, j.M.Autologous lymphapheresis for the production of car-t cells.Bone marrow transplantation.2020.55:698 investigation is in process.A follow-up report will be provided.

Event Description

The abstract, "autologous lymphapheresis for the production of car-t cells.Bone marrow transplantation" describes a study that aims to present the authors' experience in the collection of autologous t lymphocytes for the manufacture of car-tcd19 cells in adult patients with refractory or recurrent diffuse large cell lymphoma and follicular lymphoma refractory or in relapse after one line treatment, whose indication was approved by the transplant committee and advanced therapies.There were 18 procedures with a mean age of 48 years.Patients underwent apheresis with variable counts of absolute lymphocytes, with an average of 5044 cells/ml.There were 2 patients where there was microbial contamination that forced the apheresis product to be disposed of.This report is being filed for the two microbial contamination events.Patient information and outcome were not provided in the abstract.The disposable set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Investigation: per internal sterility lab documentation, the devices terumo bct manufactures to collect, separate, and store blood products are terminally sterilized to a sterility assurance level (sal) of

Event Description

This study involved autologous lymphapheresis for the production of car-t cells over a period of some time.A request for specific patient information is not feasible.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA IDL SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: scot hilden ; 10810 w. collins ave; lakewood, CO 80215 ; 3032314970
• MDR Report Key: 11528773
• MDR Text Key: 250368232
• Report Number: 1722028-2021-00121
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583103108
• UDI-Public: 05020583103108
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: BK150251
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/19/2021

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 02/22/2021
• Initial Date FDA Received: 03/19/2021
• Supplement Dates Manufacturer Received: 05/25/2022
• Supplement Dates FDA Received: 05/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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