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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 4122201
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problems Hot Flashes/Flushes (2153); Urticaria (2278); Paresthesia (4421); Swelling/ Edema (4577)
Event Date 11/13/2023
Event Type  Injury  
Event Description
The customer reported that a few minutes into a therapeutic plasma exchange (tpe) procedure the patient developed hives, tingling and swelling of the face, hot hands, and redness and throat tightness.Medical intervention was given in the form of a 50mg benadryl drip and saline.Iv calcium was given as a preventative during.The patient is reported in stable condition.The collection set is not available for return because it was discarded by the customer.
 
Manufacturer Narrative
Investigation: the device history records (dhr) were reviewed for this lot.There were no events noted in the dhr that would have contributed to the elevated wbc count experienced by the customer.Investigation is in process, a follow-up report will be provided.
 
Manufacturer Narrative
Investigation: the device history records (dhr) were reviewed for this lot.  there were no events noted in the dhr that would have contributed to the elevated wbc count experienced by the customer.A disposable complaint history search was performed for this lot and found no reports for similar issues on this lot.According to therapeutic apheresis: a physician's handbook, adverse events occur during therapeutic procedures with a frequency of 4.8%.Symptoms of these allergic reactions may include hives, dyspnea, wheezing, burning eyes, tachycardia, hypotension, and or facial swelling and flushing.Mild reactions can be treated with diphenhydramine administered through an iv.Root cause: a root cause assessment was performed for the allergic reactions.Based on the available information a definitive root cause could not be determined but it is likely due to one or a combination of the possible causes listed below: * hypersensitivity to the ethylene oxide used to sterilize the disposable set.* hypersensitivity to the components inside the disposable set.* hypersensitivity to the replacement fluid used.* patient¿s underlying disease state or sensitivity to the apheresis procedure.
 
Event Description
The customer reported that a few minutes into a therapeutic plasma exchange (tpe) procedure the patient developed hives, tingling and swelling of the face, hot hands, and redness and throat tightness.Medical intervention was given in the form of a 50mg benadryl drip and saline.Iv calcium was given as a preventative during.The patient is reported in stable condition.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 Key18283245
MDR Text Key329946942
Report Number1722028-2023-00406
Device Sequence Number1
Product Code LKN
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K183081
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 12/07/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/07/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number4122201
Device Lot Number2307143141
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/08/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured07/14/2023
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) Required Intervention;
Patient Age30 YR
Patient SexFemale
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