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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 Type  malfunction  
Manufacturer Narrative
(b)(6).Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that two (2) small volume folfusors leaked.The devices were filled with 3500 mg/3150 mg of fluoruracil in 115 ml of 0.9% sodium chloride.This occurred prior to patient use.There was no patient involvement.No additional information is available.
 
Manufacturer Narrative
The device was manufactured from apr 19, 2019 and apr 22, 2019.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
 
Manufacturer Narrative
Additional information was added: the device was manufactured from april 19, 2019 - april 22, 2019.Two (2) actual samples were received for evaluation.Visual inspection was performed and found no evidence of leak on or in any parts of the entire device.Functional testing was performed by filling the devices with green colored water.After fill, the blue winged luer cap was hand tightened.The samples were monitored until the next day and no signs of leak were observed.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.
 
Manufacturer Narrative
The actual device was not available; however, a photograph of the sample was provided for evaluation.Visual inspection was performed to the photograph and it showed no evidence of a leak.The reported problem could not be verified or refuted.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
Manufacturer (Section G)
BAXTER HEALTHCARE - IRVINE
17511 armstrong avenue
buiding 3
irvine CA 92614
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key9532694
MDR Text Key173201082
Report Number1416980-2019-07263
Device Sequence Number1
Product Code MEB
UDI-Device Identifier00085412082172
UDI-Public(01)00085412082172
Combination Product (y/n)N
Reporter Country CodeUK
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,Followup,Followup,Followup
Report Date 02/14/2020
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 Number19D054
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/04/2020
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 12/06/2019
Initial Date FDA Received12/30/2019
Supplement Dates Manufacturer Received01/08/2020
01/31/2020
02/07/2020
Supplement Dates FDA Received01/31/2020
02/04/2020
02/14/2020
Was Device Evaluated by Manufacturer? Yes
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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