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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 10225
Device Problem Infusion or Flow Problem (2964)
Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/08/2022
Event Type  malfunction  
Event Description
The customer that it was possible that the saline line was open during a procedure on spectra optia.Patient information and outcome are not available at this time.The collection set is not available for return because it was discarded by the customer.This product is not available within the us, but this report is being filed due to an alleged failure that could occur on a similarly marketed device platform cleared for use by the fda.
 
Manufacturer Narrative
Investigation is in process.A follow-up report will be provided.
 
Event Description
The customer that it was possible that the saline line was open during a procedure on spectra optia.Patient identifier is not available from the customer.Patient was reported as stable.The collection set is not available for return because it was discarded by the customer.This product is not available within the us, but this report is being filed due to an alleged failure that could occur on a similarly marketed device platform cleared for use by the fda.
 
Manufacturer Narrative
This report is being filed to provide additional information in a.2, a.3, a.4.Investigation is in process.A follow-up report will be provided.
 
Manufacturer Narrative
This report is being filed to provide additional information in h.6 and h.10.Corrected information is provided in b.3.Investigation: a disposable lot history search indicated there was no other reported occurrence of open saline roller clamp on this lot worldwide.Investigation is in process.A follow-up report will be provided.
 
Event Description
The customer that it was possible that the saline line was open during a procedure on spectra optia.Patient identifier is not available from the customer.Patient was reported as stable.The collection set is not available for return because it was discarded by the customer.This product is not available within the us, but this report is being filed due to an alleged failure that could occur on a similarly marketed device platform cleared for use by the fda.
 
Manufacturer Narrative
This report is being filed to provide additional information in h.6 and h.11.Corrected information is provided in a.1.Investigation: a disposable lot history search indicated there was no other reported occurrence of open saline roller clamp on this lot worldwide.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Investigation is in process.A follow-up report will be provided.
 
Event Description
The customer that it was possible that the saline line was open during a procedure on spectra optia.Patient was reported as stable.The collection set is not available for return because it was discarded by the customer.This product is not available within the us, but this report is being filed due to an alleged failure that could occur on a similarly marketed device platform cleared for use by the fda.
 
Event Description
The customer that it was possible that the saline line was open during a procedure on spectra optia.It was also reported that a cardiac patient experienced chills and a dry cough, referring to odynophagia during a therapeutic plasma exchange (tpe) procedure.Plasmapheresis was interrupted, the patient was given hydrocortisone 200 mg, diphenhydramine dipyrone.Patient was reported as stable.The collection set is not available for return because it was discarded by the customer.This product is not available within the us, but this report is being filed due to an alleged failure that could occur on a similarly marketed device platform cleared for use by the fda.
 
Manufacturer Narrative
Investigation: a disposable lot history search indicated there was no other reported occurrence of open saline roller clamp on this lot worldwide.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.According to therapeutic apheresis: a physician's handbook, adverse events occur during therapeutic procedures with a frequency of (b)(4).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.A root cause assessment was performed for the unintended saline bolus to the patient.Based on the customer's statement, the operator failed to follow the screen prompts to fully close the inlet saline roller clamp at the end of saline prime.
 
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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 Key14289199
MDR Text Key299598442
Report Number1722028-2022-00145
Device Sequence Number1
Product Code LKN
Combination Product (y/n)N
Reporter Country CodeBR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup,Followup,Followup
Report Date 05/04/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/05/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/01/2023
Device Catalogue Number10225
Device Lot Number2102163130
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/13/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured02/16/2021
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 Age30 YR
Patient SexFemale
Patient Weight55 KG
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