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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 D2C4705K
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
It was reported that the event occurred on an unknown day in (b)(6) 2019.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 an unspecified location.The leak was discovered during storage prior to patient use.There was no patient involvement.No additional information is available.
 
Manufacturer Narrative
The actual device was received for evaluation.A visual inspection was performed and fluid inside the bag was identified.The cause of the fluid inside the bag was due to an untightened blue winged luer cap.Functional testing was performed by filling the device with green colored water after fill, the blue winged luer cap was hand tightened.The sample was 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.
 
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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 Key9532867
MDR Text Key173200677
Report Number1416980-2019-07271
Device Sequence Number1
Product Code MEB
UDI-Device Identifier00085412474373
UDI-Public(01)00085412474373
Combination Product (y/n)N
Reporter Country CodeGM
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
Report Date 02/03/2020
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 Expiration Date04/01/2022
Device Catalogue NumberD2C4705K
Device Lot Number19D007
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/07/2020
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 12/06/2019
Initial Date FDA Received12/30/2019
Supplement Dates Manufacturer Received01/09/2020
Supplement Dates FDA Received02/03/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/12/2019
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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