IMUFLEX BLOOD BAG SYSTEM 1BBWGQ506A2

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-02-13 for IMUFLEX BLOOD BAG SYSTEM 1BBWGQ506A2 manufactured by Terumo Corporation.

Event Text Entries

[182930214] Investigation is in process. A follow-up report will be provided.
Patient Sequence No: 1, Text Type: N, H10


[182930215] The customer reported elevated white blood cell (wbc) content in a filtered whole blood unit. There was not a transfusion recipient or patient involved at the time of whole blood processing, therefore no patient information is reasonably known at the time of the event. Donor unit #:(b)(6). Terumo bct is awaiting return of the disposable set.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9681839-2020-00014
MDR Report Key9707912
Report SourceHEALTH PROFESSIONAL
Date Received2020-02-13
Date of Report2020-02-13
Date of Event2020-01-13
Date Mfgr Received2020-02-17
Date Added to Maude2020-02-13
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 ContactYOSHIKI TAKAGI
Manufacturer Street818 MISONODAIRA
Manufacturer CityFUJINOMIYA 4180004
Manufacturer Postal4180004
Manufacturer Phone44277141
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameIMUFLEX BLOOD BAG SYSTEM
Generic NameIMUFLEX WB-RP BLOOD BAG SYSTEM WITH LR FILTER
Product CodeCAK
Date Received2020-02-13
Returned To Mfg2020-01-27
Catalog Number1BBWGQ506A2
Lot Number181025AF
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerTERUMO CORPORATION
Manufacturer AddressFUJINOMIYA


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-02-13

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.