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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 12220
Device Problems No Apparent Adverse Event (3189); Insufficient Information (3190)
Patient Problem Low Blood Pressure/ Hypotension (1914)
Event Date 09/23/2022
Event Type  Death  
Event Description
The customer reported that post therapeutic plasma exchange (tpe) procedure, a patient coded and passed away.Per the rn, the patient was extremely sick and the procedure was ordered as a last resort to try and stabilize this patient; he was not expected to survive the procedure.The procedure ran fine until rinseback was performed, which is when the patient coded and passed away.They were pushing all pressure meds, including bicarb to attempt to stabilize this patient, as per rn.The customer declined to provide the patient identifier.The disposable is not available for return because it was discarded by the customer.This report is being filed due to patient death, although per current information there is no detectable malfunction with the terumo bct device or allegation of a malfunction.
 
Manufacturer Narrative
Investigation: per the customer, the patient cause of death was sepsis and multi organ failure and the procedure did not contribute.Investigation is in process.A follow up report will be provided.
 
Manufacturer Narrative
Investigation: per the customer, the patient cause of death was sepsis and multi organ failure and the procedure did not contribute.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 death was not related to the device and was determined to be to the patient disease state only.No further reporting will be provided as this does not represent a reportable event.
 
Event Description
The customer reported that post therapeutic plasma exchange (tpe) procedure, a patient coded and passed away.Per the rn, the patient was extremely sick and the procedure was ordered as a last resort to try and stabilize this patient; he was not expected to survive the procedure.The procedure ran fine until rinseback was performed, which is when the patient coded and passed away.They were pushing all pressure meds, including bicarb to attempt to stabilize this patient, as per rn.The customer declined to provide the patient identifier.The disposable is not available for return because it was discarded by the customer.This report is being filed due to patient death, although per current information there is no detectable malfunction with the terumo bct device or allegation of a malfunction.
 
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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 Key15651434
MDR Text Key302193496
Report Number1722028-2022-00347
Device Sequence Number1
Product Code GKT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
BK150251
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 10/21/2022
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 Catalogue Number12220
Device Lot Number2208243130
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/27/2022
Initial Date FDA Received10/21/2022
Supplement Dates Manufacturer Received11/23/2022
Supplement Dates FDA Received12/08/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured08/26/2022
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;
Patient Age26 YR
Patient SexMale
Patient Weight115 KG
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