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

Model Number 10220

Device Problem Insufficient Information (3190)

Patient Problem Fever (1858)

Event Date 12/31/2019

Event Type  Injury  

Manufacturer Narrative

Lot number and expiry are not available at this time.Article citation: johann, pascal d., et.Al.2022.Identifying patient groups that may benefit from granulocyte transfusions in pediatric hematology and oncology.Journal of pediatric hematology/oncology.44:7, e968¿e975.Investigation is in process.A follow up report will be provided.

Event Description

The journal article, 'identifying patient groups that may benefit from granulocyte transfusions in pediatric hematology and oncology' describes a retrospective review of patients treated with granulocyte transfusions from 2004 to 2019, median age 3 years, age range 1 to 10 years.In 99 granulocyte transfusions, the chart review identified 2 possibly related adverse events: patients 7 reacted with fever during the transfusion.In this case, this was not clearly attributable to the granulocyte infusion but could also have developed in the context of the ongoing infection.Of 10 patients who received allogeneic stem cell transplantation and survived until at least 28 days after transplantation, none experienced graft rejection and 1 suffered from acute and chronic gvhd.The article does not specify if medical intervention was required.The article does not provide further patient information details.The collection sets are not available for return for evaluation.

• 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: 16496101
• MDR Text Key: 310801540
• Report Number: 1722028-2023-00096
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/07/2023

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: 10220
• Device Catalogue Number: 10220
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/10/2023
• Initial Date FDA Received: 03/07/2023
• 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