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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE - IRVINE FOLFUSOR; PUMP, INFUSION, ELASTOMERIC

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BAXTER HEALTHCARE - IRVINE FOLFUSOR; PUMP, INFUSION, ELASTOMERIC Back to Search Results
Catalog Number 2C4009K
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Event Description
It was reported that a large volume folfusor experienced a leak.The leakage site was not specified.The issue occurred during filling of the device with fluorouracil.There was no patient involvement.No additional information is available.
 
Manufacturer Narrative
(b)(4).The device was received and is currently in the process of being evaluated.Should additional relevant information become available, a supplemental report will be submitted.
 
Manufacturer Narrative
(b)(4).This lot was manufactured april 20, 2014 to april 21, 2014.Evaluation summary: visual inspection noted fluid in the bag that contained the unit.The leak was coming from an untightened blue winged luer cap.A functional test was performed and the blue winged luer cap was hand tightened.The next day there were no signs of a leak at the luer cap.The reported condition could not be 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.
 
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Brand Name
FOLFUSOR
Type of Device
PUMP, INFUSION, ELASTOMERIC
Manufacturer (Section D)
BAXTER HEALTHCARE - IRVINE
17511 armstrong avenue
bldg 3
irvine CA 92614
Manufacturer (Section G)
BAXTER HEALTHCARE - IRVINE
17511 armstrong avenue
bldg 3
irvine CA 92614
Manufacturer Contact
kinga almasan
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key4376112
MDR Text Key5239392
Report Number1416980-2014-48165
Device Sequence Number1
Product Code MEB
Combination Product (y/n)N
Reporter Country CodeDA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 12/09/2014
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 Expiration Date04/01/2016
Device Catalogue Number2C4009K
Device Lot Number14D035
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/15/2014
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 01/07/2015
Initial Date FDA Received12/31/2014
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received02/01/2015
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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