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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 Device Contamination with Chemical or Other Material (2944)
Patient Problem No Patient Involvement (2645)
Event Date 11/18/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(6).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 presence of grain was observed in the tubing of a small volume folfusor.This issue was identified prior to patient use.There was no patient involvement.No additional information is available.
 
Manufacturer Narrative
Additional information : the device was received for evaluation.A visual inspection was performed and a reddish brown particulate matter (pm) was observed in the tubing line.The particle was identified to be polyvinyl chloride (pvc) material.The particle has no contact to the fluid path because it was embedded in the material of the tubing line.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 Key9520897
MDR Text Key172831920
Report Number1416980-2019-07148
Device Sequence Number1
Product Code MEB
UDI-Device Identifier00085412082172
UDI-Public(01)00085412082172
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Pharmacist
Type of Report Initial,Followup
Report Date 01/24/2020
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 Number19E032
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/11/2019
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/03/2019
Initial Date FDA Received12/26/2019
Supplement Dates Manufacturer Received01/07/2020
Supplement Dates FDA Received01/24/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/23/2019
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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