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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 2C4009K
Device Problem No Flow (2991)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The device was received and is currently awaiting evaluation.Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that a large volume folfusor experienced no flow while in use on a patient; further described as ¿when the patient returned after days for disconnection, the pump was full.The hospital staff noticed that there was no flow and the device was not able to begin the infusion/drug delivery.¿ there was no report of patient injury or medical intervention associated with this event.No additional information is available.
 
Manufacturer Narrative
The device was received for evaluation.A visual inspection was performed, and it was noted that there were no signs of blockage inside the tubing line or the bladder.A functional flow test was performed, and it was noted that there was no evidence of flow observed coming out of the distal luer.Microscopic examination of the flow restrictor revealed the cause of the no flow problem was due to white crystallized drug blocking the fluid path at the distal end of the glass capillary.The glass capillary is located inside the flow restrictor.The reported condition was 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 Key9532828
MDR Text Key173202208
Report Number1416980-2019-07269
Device Sequence Number1
Product Code MEB
UDI-Device Identifier00085412080130
UDI-Public(01)00085412080130
Combination Product (y/n)N
Reporter Country CodeGR
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 01/31/2020
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 Number2C4009K
Device Lot Number19G030
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/20/2019
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 12/05/2019
Initial Date FDA Received12/30/2019
Supplement Dates Manufacturer Received01/08/2020
Supplement Dates FDA Received02/01/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/18/2019
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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