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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 D2C4711K
Device Problem Material Rupture (1546)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that a small volume folfusor burst with cytostatic fluorouracil.This event occurred during preparation.There was no patient involvement.No additional information is available.
 
Manufacturer Narrative
H4: the lot was manufactured from march 28, 2023 - march 29, 2023.Correction made to d4: catalogue #: d2c4711k (previously submitted as 2c4711k).Correction made to d4: lot#: 23c017 (previously submitted as 22n020).Correction made to d4: udi#: (b)(4) (previously submitted as (b)(4)).The device was received for evaluation.A visual inspection with the naked eye was performed and a ruptured bladder was observed.The ruptured bladder was examined and there were no signs of abnormality found on the bladder that may have led to the rupture.The reported condition was verified.The cause of the condition could not be determined; however, a possible cause may be due to inherent variation in the material, as bladders are manufactured with rubber.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 Key17185605
MDR Text Key318126387
Report Number1416980-2023-03101
Device Sequence Number1
Product Code MEB
UDI-Device Identifier00085412474311
UDI-Public(01)00085412474311
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 Foreign,Health Professional,Company Representative
Reporter Occupation Pharmacist
Type of Report Initial,Followup
Report Date 07/25/2023
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 NumberD2C4711K
Device Lot Number23C017
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/31/2023
Initial Date FDA Received06/22/2023
Supplement Dates Manufacturer Received07/12/2023
Supplement Dates FDA Received07/25/2023
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 Initial
Patient Sequence Number1
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