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 09/21/2022

Event Type  Injury  

Manufacturer Narrative

Lot number and expiry are not available at this time.Article citation: partanen, a., et.Al.2023.Impact of the number of cryopreserved cd34+ cells in the infused blood grafts on hematologic recovery and survival in myeloma patients after autologous stem cell transplantation: experience from the goa study.Journal of clinical apheresis.2023.38:33-44.Investigation is in process.A follow up report will be provided.

Event Description

The journal article, 'impact of the number of cryopreserved cd34+ cells in the infused blood grafts on hematologic recovery and survival in myeloma patients after autologous stem cell transplantation: experience from the goa study' describes a post-hoc study aimed to investigate factors associating with cd34+ cell loss during cryopreservation and the effects of the infusion of a very low number (<1.0 x 10^6/kg, group a), low number (1¿1.9 x 10^6/kg, group b), and optimal number (=2 x 10^6 /kg, group c) of thawed viable cd34+ cells on hematologic recovery, progression free survival, and overall survival after autologous stem cell transplantation among 127 patients with multiple myeloma (mm).Between may 2012 and december 2016, altogether 147 patients with mm were included.During the time at hospital, the incidence of febrile neutropenia was highest in group b but without statistical significance.The incidence of positive blood cultures was comparable among the three groups.The article does not specify individual patient information or whether medical intervention was required for the adverse events, therefore this report is being provided as a summary of events.The collection sets are not available for return for evaluation.

Event Description

The journal article, 'impact of the number of cryopreserved cd34+ cells in the infused blood grafts on hematologic recovery and survival in myeloma patients after autologous stem cell transplantation: experience from the goa study' describes a post-hoc study aimed to investigate factors associating with cd34+ cell loss during cryopreservation and the effects of the infusion of a very low number (<1.0 x 10^6/kg, group a), low number (1¿1.9 x 10^6/kg, group b), and optimal number (=2 x 10^6 /kg, group c) of thawed viable cd34+ cells on hematologic recovery, progression free survival, and overall survival after autologous stem cell transplantation among 127 patients with multiple myeloma (mm).Between may 2012 and december 2016, altogether 147 patients with mm were included.During the time at hospital, the incidence of febrile neutropenia was highest in group b but without statistical significance.The incidence of positive blood cultures was comparable among the three groups.The article does not specify individual patient information or whether medical intervention was required for the adverse events, therefore this report is being provided as a summary of events.The collection sets are not available for return for evaluation.

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.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.There is no allegation of any adverse events and any mention of death is in relation to disease reoccurrence and/or progression and outside a 72h window.No further reporting will be provided as this does not represent a reportable event.Article citation: partanen, a., et.Al.2023.Impact of the number of cryopreserved cd34+ cells in the infused blood grafts on hematologic recovery and survival in myeloma patients after autologous stem cell transplantation: experience from the goa study.Journal of clinical apheresis.2023.38:33-44.

• 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: 16531524
• MDR Text Key: 311223896
• Report Number: 1722028-2023-00102
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583102200
• UDI-Public: 05020583102200
• Combination Product (y/n): N
• Reporter Country Code: FI
• 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: Physician
• Type of Report: Initial
• Report Date: 03/13/2023

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: 02/21/2023
• Initial Date FDA Received: 03/13/2023
• 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