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 2020-02-07 for IMUFLEX BLOOD BAG SYSTEM 1BBWGQ506A2 manufactured by Terumo Corporation.

Event Text Entries

[182232266] Investigation: the blood bag set was not returned for evaluation. The manufacturing records, test records, and inspection records were reviewed for abnormalities and none were found. The records regarding the particulate removal rates of the filter membranes were reviewed. All membranes conformed to established specification. Shipping testing was performed on the reserve samples from the reported lot number. The reserve samples were also visually examined, and the solution volume and solution composition were tested with no abnormalities noted. All product conformed to the established specification. Regarding the reported lot number, we reviewed whether there had been any complaints reported by other customers. The results revealed that complaints against wbc contamination associated with this lot number had not been reported by any other customers as of january 20, 2020. Root cause: we reviewed the manufacturing record and the testing and inspection record of the reported lot number; however, we did not find any abnormalities and we were not able to identify the cause of the issue.
Patient Sequence No: 1, Text Type: N, H10


[182232267] 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) the collection set is not available for return because it was discarded by the customer.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9681839-2020-00003
MDR Report Key9681375
Report SourceHEALTH PROFESSIONAL
Date Received2020-02-07
Date of Report2020-02-07
Date of Event2020-01-09
Date Mfgr Received2020-01-14
Date Added to Maude2020-02-07
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 418-0004
Manufacturer CountryJP
Manufacturer Postal418-0004
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 Received2020-02-07
Catalog Number1BBWGQ506A2
Lot Number190311AG
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerTERUMO CORPORATION
Manufacturer AddressFUJINOMIYA JP


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-02-07

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