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

Model Number 10310

Device Problem Insufficient Information (3190)

Patient Problem Sepsis (2067)

Event Date 11/16/2022

Event Type  Injury  

Event Description

In journal article: "syngeneic hematopoietic stem cell transplantation after mobilization failure in an adolescent with intracranial germ cell tumor", by sánchez-sierra, n.Et al it was reported that the patient received hdct based on siop-cns-gct-ii guidelines and a non-manipulated syngeneic graft.Given the cellularity of the product (2.4 × 106 cd34+/kg), he received subcutaneous g-csf from day+5 to 2 days after reaching the white blood cell graft (day+9) as well as corticosteroid prophylaxis of the engraftment syndrome.As main complications, he developed escherichia coli sepsis, grade 3 hyperemesis, and mucositis.Antiviral and antibiotic prophylaxis was discontinued 4 months after shsct.The patient continued treatment as planned with focal proton beam radiation therapy.He ended treatment 8 months after diagnosis and is currently in complete remission.Patient id and weight are not available at this time as they were not included in the article for this event.The disposable set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Lot number and expiry information were not included in the article and are not available.Investigation is in process, a follow-up report will be provided.Citation: sánchez-sierra, n., perez-somarriba, m., santa-maria, v., cruz, o., garcía-rey, e., martorell, l., rovira, m., margarit, a., & marsal, j.(2023).Syngeneic hematopoietic stem cell transplantation after mobilization failure in an adolescent with intracranial germ cell tumor.Pediatric blood & cancer, 70(5).Https://doi.Org/10.1002/pbc.30177.

• 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 hilton ; 10810 w. collins ave; lakewood, CO 80215
• MDR Report Key: 16887541
• MDR Text Key: 314753402
• Report Number: 1722028-2023-00172
• Device Sequence Number: 1
• Product Code: LKN
• UDI-Device Identifier: 05020583103108
• UDI-Public: 05020583103108
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K183081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/13/2023
• Initial Date FDA Received: 05/08/2023
• 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; Required Intervention
• Patient Age: 13 YR
• Patient Sex: Male