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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 2C4711K
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Patient Involvement (2645)
Event Date 12/02/2019
Event Type  malfunction  
Manufacturer Narrative
The device was manufactured from may 13, 2019 - may 14, 2019.The actual device was discarded; however, a photograph of the sample was provided for evaluation.Visual inspection of the photograph was performed and a leak inside a bag that contained the device was identified; however the location of the leak was not determined.The reported condition was verified.The cause of the reported 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.
 
Event Description
It was reported that a small volume folfusor was leaking from the blue wing cap.This was identified during filling with fluorouracil 4000mg in 5% glucose.There was no patient involvement.No additional information is available.
 
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Brand Name
FOLFUSOR
Type of Device
PUMP, INFUSION, ELASTOMERIC
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
Manufacturer (Section G)
BAXTER HEALTHCARE - IRVINE
17511 armstrong avenue
building 3
irvine CA 92614
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key9521102
MDR Text Key172767141
Report Number1416980-2019-07151
Device Sequence Number1
Product Code MEB
UDI-Device Identifier00085412082172
UDI-Public(01)00085412082172
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Initial
Report Date 12/26/2019
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 Number2C4711K
Device Lot Number19E035
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/02/2019
Initial Date FDA Received12/26/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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