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

Model Number 10220

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

Patient Problems Anemia (1706); Low White Blood Cell Count (4433)

Event Date 12/31/2021

Event Type  Injury  

Event Description

The journal article, "apheresis for chimeric antigen receptor t-cell production in adult lymphoma patients", describes a retrospective study of 23 patients (age 37¿77 years) suffering from relapsed/refractory non-hodgkin's lymphoma who underwent autologous lymphapheresis as preparation for subsequent treatment with cd19-specific car t cells between april 2019 and december 2021.4 patients required blood transfusions after lymphapheresis due to drop in hemoglobin levels (this was expected).2 patients failed t-cell collection - this was due to severe lymphopenia and depressed t-cell counts prior to lymphapheresis - not due to device function.Specific patient details were not provided, therefore this report is being submitted as a summary of events.The disposable sets are not available for return for analysis.

Manufacturer Narrative

Lot number and expiry are not available at this time.Article citation: harrer dc, heidenreich m, fante ma, et al.Apheresis for chimeric antigen receptor t-cell production in adult lymphoma patients.Transfusion.2022.Investigation is in process.A follow up report will be provided.

• 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: 15234849
• MDR Text Key: 298026309
• Report Number: 1722028-2022-00269
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583102200
• UDI-Public: 05020583102200
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10220
• Device Catalogue Number: 10220
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/22/2022
• 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