SPECTRA OPTIA 10225

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-03-06 for SPECTRA OPTIA 10225 manufactured by Terumo Bct.

Event Text Entries

[185295303] Investigation is in process. A follow-up report will be provided.
Patient Sequence No: 1, Text Type: N, H10


[185295304] The customer reported that one hour into the apheresis procedure, they noticed air bubbles in the blood warmer tubing line. They decided to remove the blood warmer, then finish the procedure without the blood warmer. Patient information and outcome are unavailable at this time. The disposable 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1722028-2020-00089
MDR Report Key9796545
Report SourceFOREIGN,HEALTH PROFESSIONAL
Date Received2020-03-06
Date of Report2020-03-05
Date of Event2020-02-06
Date Mfgr Received2020-02-12
Device Manufacturer Date2019-09-24
Date Added to Maude2020-03-06
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactSCOT HILDEN
Manufacturer Street10810 W. COLLINS AVE
Manufacturer CityLAKEWOOD CO 80215
Manufacturer CountryUS
Manufacturer Postal80215
Manufacturer Phone3032314970
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSPECTRA OPTIA
Generic NameSPECTRA OPTIA EXCHANGE SET
Product CodeLKN
Date Received2020-03-06
Catalog Number10225
Lot Number1909233230
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerTERUMO BCT
Manufacturer AddressLAKEWOOD CO 80215 US 80215


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-03-06

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