MAUDE Adverse Event Report: TERUMO BCT COBE SPECTRA; COBE SPECTRA RBCX SET

Model Number 70700

Device Problem Insufficient Information (3190)

Patient Problems Sepsis (2067); Thrombocytopenia (4431); Low White Blood Cell Count (4433)

Event Date 06/30/2017

Event Type  Injury  

Event Description

The journal article, 'intermediate-dose cyclophosphamide and bortezomib for pbsc mobilization in multiple myeloma', describes a study of the mobilization efficacy, safety, and disease response of intermediate-dose cyclophosphamide (total 4 g/m2 ) and bortezomib (bor-id-cy) for pbsc mobilization in patients with newly diagnosed multiple myeloma (mm) who had undergone induction therapy, and compared these with the responses in a historical control group who received intermediate-dose cyclophosphamide (id-cy), without bortezomib, for peripheral blood stem cell (pbsc) mobilization at the same hospitals.Four patients (19 %) in the bor-id-cy group and four patients (27 %) in the id-cy group developed febrile neutropenia.Nine patients (43 %) in the bor-id-cy group and four patients (27 %) in the id-cy group needed platelet transfusions (table 5).Four patients in the bor-id-cy group developed sepsis, and the confirmed pathogens were: staphylococcus aureus, streptococcus mitis, streptococcus oralis, and citrobacter freundii (n = 1 each).No cases of sepsis were reported in the id-cy group (table 5).There were no other serious non-hematologic toxicities in the two groups (table 5), and no patient developed peripheral neuropathy.The article does not provide individual patient information, therefore this report is being provided as a summary of events.The collection sets are not available for return for evaluation.

Manufacturer Narrative

Lot number and expiry are not available at this time.Article citation: sawazaki, a., sugimori, c., yamaguchi, m., and nakao, s.2022.Intermediate-dose cyclophosphamide and bortezomib for pbsc mobilization in multiple myeloma, transfusion and apheresis science, (2022) doi: https://doi.Org/10.1016/j.Transci.2023.103649.Investigation is in process.A follow up report will be provided.

• Brand Name: COBE SPECTRA
• Type of Device: COBE SPECTRA RBCX 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: 16454011
• MDR Text Key: 310381809
• Report Number: 1722028-2023-00082
• Device Sequence Number: 1
• Product Code: LKN
• UDI-Device Identifier: 35020583707000
• UDI-Public: 35020583707000
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: BK020041
• 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: 02/28/2023

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: 70700
• Device Catalogue Number: 70700
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/03/2023
• Initial Date FDA Received: 02/28/2023
• 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