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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION FOLFUSOR; PUMP, INFUSION, ELASTOMERIC
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BAXTER HEALTHCARE CORPORATION FOLFUSOR; PUMP, INFUSION, ELASTOMERIC Back to Search Results
Catalog Number D2C4009K
Device Problem Filling Problem (1233)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
It was reported that the event occurred on an unknown day in (b)(6) of 2021.Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that a large volume folfusor underinfused medication to the patient.After the expected therapy time was complete, it was observed that 50ml of residual volume remained within the device and had not been delivered to the patient.The device had been filled with 5-fluorouracil and saline solution.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
 
Manufacturer Narrative
H10: the device was not returned.And the lot number is unknown.Therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
 
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Brand Name
FOLFUSOR
Type of Device
PUMP, INFUSION, ELASTOMERIC
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
MDR Report Key11351552
MDR Text Key232837100
Report Number1416980-2021-00765
Device Sequence Number1
Product Code MEB
Combination Product (y/n)Y
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Type of Report Initial,Followup
Report Date 03/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberD2C4009K
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 01/25/2021
Initial Date FDA Received02/19/2021
Supplement Dates Manufacturer Received02/24/2021
Supplement Dates FDA Received03/22/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
5-FLUOROURACIL; SALINE SOLUTION 0.9%
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