FOLFUSOR 2C4705K

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-24 for FOLFUSOR 2C4705K manufactured by Baxter Healthcare Corporation.

Event Text Entries

[184665616] Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10


[184665617] It was reported a small volume folfusor leaked. It was further reported? During the filling phase? The? Diana tool that allows them to fill elastomers and empty bags? Was found to have? Instead of entering the balloon and inflating it, the drug was present in the rigid transparent chamber containing the balloon? The set was filled with 5-fluorouracil diluted in 0. 9% saline solution. There was no patient involvement. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5


[188762713] The actual device was not available; however, a photograph of the sample was provided for evaluation. A visual inspection was performed of the photograph which observed a wet bag containing the device indicating a leak; the exact location of the leak could not be identified. No additional testing could be performed due to the nature of the sample. The reported condition was verified. The cause of the condition could not be determined. A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot. Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1416980-2020-01664
MDR Report Key9872083
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-24
Date of Report2020-03-24
Date Mfgr Received2020-02-27
Date Added to Maude2020-03-24
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPHARMACIST
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer Street25212 W. ILLINOIS ROUTE 120
Manufacturer CityROUND LAKE IL 60073
Manufacturer CountryUS
Manufacturer Postal60073
Manufacturer Phone2242702068
Manufacturer G1BAXTER HEALTHCARE - IRVINE
Manufacturer Street17511 ARMSTRONG AVENUE BUILDING 3
Manufacturer CityIRVINE CA 92614
Manufacturer CountryUS
Manufacturer Postal Code92614
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameFOLFUSOR
Generic NamePUMP, INFUSION, ELASTOMERIC
Product CodeMEB
Date Received2020-03-24
Model NumberNA
Catalog Number2C4705K
Lot Number17N011
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBAXTER HEALTHCARE CORPORATION
Manufacturer AddressDEERFIELD IL


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-24

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