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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO BCT SPECTRA OPTIA; SPECTRA OPTIA EXCHANGE SET
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TERUMO BCT SPECTRA OPTIA; SPECTRA OPTIA EXCHANGE SET Back to Search Results
Catalog Number 10220
Device Problems No Apparent Adverse Event (3189); Insufficient Information (3190)
Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/08/2023
Event Type  malfunction  
Manufacturer Narrative
Lot number, manufacture and expiry date are not available at this time.Investigation is in process, a follow-up report will be provided.Turunen, a., kuittinen, o., kuitunen, h., vasala, k., penttilä, k., harmanen, m., keskinen, l., mäntymaa, p., pelkonen, j., varmavuo, v., jantunen, e., & partanen, a.(2023).Cd34+ cell mobilization, autograft cellular composition and outcome in mantle cell lymphoma patients.Transfusion medicine and hemotherapy, 50(5), 428¿437.Https://doi.Org/10.1159/000531799.
 
Event Description
Per journal article "cd34+ cell mobilization, autograft cellular composition and outcome in mantle cell lymphoma patients" by antti samuli turunen outi kuittinen, hanne kuitunen, kaija vasala, karri penttilä, minna harmanen, leena keskinen, pentti mäntymaa, jukka pelkonen, ville varmavuo, esa jantunen, anu partanen per the article, autologous stem cell transplantation (asct) is a standard treatment in transplant-eligible mantle cell lymphoma (mcl) patients after first-line chemoimmunotherapy.Study design and methods: this prospective multicenter study evaluated the impact of cd34+ cell mobilization and graft cellular composition analyzed by flow cytometry on hematologic recovery and outcome in 42 mcl patients specific details, such as patient information and outcome, were not included in the article for these events, therefore this report is being provided as a summary of the events.It is unknown that this time if medical intervention was required for these events.The collection set is not available for return because it was discarded by the customer.
 
Manufacturer Narrative
This report is being filed to provide additional information in h.6 and h.11.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 this event did not have or allege medical intervention.No further reporting will be provided as this does not represent a reportable event.Turunen, a., kuittinen, o., kuitunen, h., vasala, k., penttilä, k., harmanen, m., keskinen, l., mäntymaa, p., pelkonen, j., varmavuo, v., jantunen, e., & partanen, a.(2023).Cd34+ cell mobilization, autograft cellular composition and outcome in mantle cell lymphoma patients.Transfusion medicine and hemotherapy, 50(5), 428¿437.Https://doi.Org/10.1159/000531799.
 
Event Description
Per journal article "cd34+ cell mobilization, autograft cellular composition and outcome in mantle cell lymphoma patients" by antti samuli turunen outi kuittinen, hanne kuitunen, kaija vasala, karri penttilä, minna harmanen, leena keskinen, pentti mäntymaa, jukka pelkonen, ville varmavuo, esa jantunen, anu partanen per the article, autologous stem cell transplantation (asct) is a standard treatment in transplant-eligible mantle cell lymphoma (mcl) patients after first-line chemoimmunotherapy.Study design and methods: this prospective multicenter study evaluated the impact of cd34+ cell mobilization and graft cellular composition analyzed by flow cytometry on hematologic recovery and outcome in 42 mcl patients specific details, such as patient information and outcome, were not included in the article for these events, therefore this report is being provided as a summary of the events.It is unknown that this time if medical intervention was required for these events.The collection set is not available for return because it was discarded by the customer.
 
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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 Key18791391
MDR Text Key337527545
Report Number1722028-2024-00067
Device Sequence Number1
Product Code LKN
Combination Product (y/n)N
Reporter Country CodeFI
PMA/PMN Number
K183081
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Literature
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/27/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/27/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number10220
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/03/2024
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 Number1
Patient Outcome(s) Other;
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