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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO BCT SPECTRA OPTIA; SPECTRA OPTIA EXCHANGE SET,EA
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TERUMO BCT SPECTRA OPTIA; SPECTRA OPTIA EXCHANGE SET,EA Back to Search Results
Model Number 12220
Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Patient Problem Chills (2191)
Event Date 10/08/2022
Event Type  Injury  
Event Description
The customer reported that on during administration of the last red blood cell unit for the red blood cell exchange (rbcx) procedure, before finishing the last unit as replacement, the patient experienced chills.The operator called the physician.Physician ordered to terminate the procedure and the patient was sent to er for hydration with saline.A transfusion reaction panel was ordered, the transfusion reaction panel was negative, blood culture negative.Before patient was transferred to er, the bp was 90/40.Patient was stable, bp 128/68, and sent home after hydration.Patient id and age are not available at this time.The rbcx set is not available for return because it was discarded by the customer.
 
Manufacturer Narrative
Lot number and expiry are not available at this time.Investigation: per the customer, the transfusion reaction panel was negative, blood culture negative.The doctor stated that the patient had a vaccine the day before and this was a reaction to the vaccine received.Investigation is in process.A follow up report will be provided.
 
Manufacturer Narrative
Lot number and expiry are not available at this time.Investigation: per the customer, the transfusion reaction panel was negative, blood culture negative.The doctor stated that the patient had a vaccine the day before and this was a reaction to the vaccine received.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 transfusion reaction panel was negative, blood culture negative.Dr.Stated that the patient had a vaccine the day before and was a reaction to the vaccine received.Patient was sent home after the hydration.No further reporting will be provided as this does not represent a reportable event.
 
Event Description
The customer reported that on during administration of the last red blood cell unit for the red blood cell exchange (rbcx) procedure, before finishing the last unit as replacement, the patient experienced chills.The operator called the physician.Physician ordered to terminate the procedure and the patient was sent to er for hydration with saline.A transfusion reaction panel was ordered, the transfusion reaction panel was negative, blood culture negative.Before patient was transferred to er, the bp was 90/40.Patient was stable, bp 128/68, and sent home after hydration.Patient id and age are not available at this time.The rbcx 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,EA
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 Key15716316
MDR Text Key302875486
Report Number1722028-2022-00355
Device Sequence Number1
Product Code GKT
UDI-Device Identifier05020583122208
UDI-Public05020583122208
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 Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/02/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/02/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number12220
Device Catalogue Number12220
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/11/2023
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 Number1
Patient Outcome(s) Hospitalization;
Patient SexMale
Patient Weight120 KG
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