Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO BCT SPECTRA OPTIA; SPECTRA OPTIA EXCHANGE SET
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

TERUMO BCT SPECTRA OPTIA; SPECTRA OPTIA EXCHANGE SET Back to Search Results
Catalog Number 10226
Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problems Erythema (1840); Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943)
Event Date 06/10/2022
Event Type  Injury  
Event Description
The customer reported that a patient appeared to have an anaphylactic reaction during a tpe procedure.Per the customer, 30mins after the procedure finished, the patient felt itchy skin and erythema appeared.The operator gave the patient 5mg hexadecadrol per physician order by intravenous injection.Prior to the procedure, the patient was administered 10% calcium gluconate 20ml.During the procedure, the patient was administered 10% calcium gluconate 20ml at 16:40 and 10% calcium gluconate 20ml at 17:30.The disposable set is not available for return for evaluation.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.
 
Manufacturer Narrative
This report is being filed to provide additional information in e.1 and e.3.Investigation is in process.A follow up report will be provided.
 
Event Description
The customer reported that a patient appeared to have an anaphylactic reaction during a tpe procedure.Per the customer, 30mins after the procedure finished, the patient felt itchy skin and erythema appeared.The operator gave the patient 5mg hexadecadrol per physician order by intravenous injection.Prior to the procedure, the patient was administered 10% calcium gluconate 20ml.During the procedure, the patient was administered 10% calcium gluconate 20ml at 16:40 and 10% calcium gluconate 20ml at 17:30.The disposable set is not available for return for evaluation.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 reported that a patient appeared to have an anaphylactic reaction during a tpe procedure.Per the customer, 30mins after the procedure finished, the patient felt itchy skin and erythema appeared.The operator gave the patient 5mg hexadecadrol per physician order by intravenous injection.Prior to the procedure, the patient was administered 10% calcium gluconate 20ml.During the procedure, the patient was administered 10% calcium gluconate 20ml at 16:40 and 10% calcium gluconate 20ml at 17:30.The disposable set is not available for return for evaluation.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: investigation: based on literature reference, therapeutic apheresis: a physician's handbook, allergic reactions are usually associated with replacement procedures that include blood components but sensitivity to disposable tubing sterilized with ethylene oxide can also be associated with allergic reactions a disposable complaint history search was performed for this lot and found a total of 4 occurrences were reported across 2 complaint records from the same customer for similar issues worldwide.See mdr 1722028-2022-00274,  mdr 1722028-2022-00275, mdr 1722028-2022-000277, mdr 1722028-2022-00279.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.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.The run data file (rdf) was analyzed for this event.There were no signals or alarms in the rdf that would indicate issues during the run, specifically the amount of ac delivered.The commanded ac pump speed and the measured ac pump speed were accurate and did not show any discrepancy in pump volume.Root cause: a root cause assessment was performed for this complaint.Based on customer's statements about the allergic reactions and the literature review, possible causes for the patient reactions include but are not limited to an allergy to replacement solution and/or patient sensitivity to eto.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key15252057
MDR Text Key298164356
Report Number1722028-2022-00274
Device Sequence Number1
Product Code LKN
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
BK150251
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Nurse
Type of Report Initial,Followup,Followup
Report Date 08/18/2022
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 Expiration Date10/01/2023
Device Catalogue Number10226
Device Lot Number2110013230
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/26/2022
Initial Date FDA Received08/18/2022
Supplement Dates Manufacturer Received05/04/2023
05/19/2023
Supplement Dates FDA Received05/08/2023
05/31/2023
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/01/2021
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; Required Intervention;
Patient Age45 YR
Patient SexMale
Patient Weight75 KG
-
-