FOLFUSOR 2C4711K

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 2020-03-25 for FOLFUSOR 2C4711K manufactured by Baxter Healthcare Corporation.

Event Text Entries

[184861557] The device was received and is currently awaiting evaluation completion. Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10


[184861558] It was reported a small volume folfusor under infused. The expected infusion time was 46 hours; however, after "50 plus hours the reservoir was not empty". The device had been filled with 5-fluorouracil. This issue was identified after use of the device. There was no report of patient injury or medical intervention associated with this event. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5


[188469828] Additional information was added: the device was manufactured from july 29, 2019 - july 30, 2019. The actual device was received for evaluation containing 72 ml of fluid in the bladder. A visual inspection was performed using the naked eye which did not identify any abnormalities that could have contributed to the reported condition. A functional flow rate test was performed and found to be within the product specification range. The reported condition was not verified. 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 Number1416980-2020-01699
MDR Report Key9878180
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-25
Date of Report2020-03-25
Date of Event2020-02-02
Date Mfgr Received2020-02-28
Date Added to Maude2020-03-25
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
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 Received2020-03-25
Returned To Mfg2020-03-09
Model NumberNA
Catalog Number2C4711K
Lot Number19G041
Device AvailabilityR
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerBAXTER HEALTHCARE CORPORATION
Manufacturer AddressDEERFIELD IL


Patients

Patient NumberTreatmentOutcomeDate
15 2020-03-25

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