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

Model Number	70700
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Sepsis (2067); Thrombocytopenia (4431); Low White Blood Cell Count (4433); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2017
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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.
Additional Manufacturer Narrative
This report is being filed to provide additional information in h.6 and h.11.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 further evaluation of this event has determined that the device did not cause or contribute to a death or serious injury, nor is there a likely potential for death or serious injury associated with this event based on additional investigational information.It was confirmed that the authors documented the adverse events are linked to the type of mobilization therapy and not the device.No further reporting will be provided as this does not represent a reportable event. .
Event or Problem 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.

• Brand Name: COBE SPECTRA
• Common Device Name: 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
• Report Number: 1722028-2023-00082
• Device Sequence Number: 20298484
• Product Code: LKN
• UDI-Device Identifier: 05020583707009
• UDI-Public: 05020583707009
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: BK020041
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: 70700
• Device Catalogue Number: 70700
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2023
• Supplement Date Received by Manufacturer: 06/19/2024
• Initial Report FDA Received Date: 02/28/2023
• Supplement Report FDA Received Date: 06/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown