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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION INFUSOR; PUMP, INFUSION, ELASTOMERIC

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BAXTER HEALTHCARE CORPORATION INFUSOR; PUMP, INFUSION, ELASTOMERIC Back to Search Results
Catalog Number 2C1009K
Device Problem Material Rupture (1546)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/31/2022
Event Type  malfunction  
Event Description
It was reported that the bladder of a large volume infusor ruptured; 50ml of solution was remaining.The device was filed with normal saline 0.9% + fluorouracil with a total infusion volume of 240ml.This was observed during patient infusion.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
 
Manufacturer Narrative
(b)(6).Should additional relevant information become available, a supplemental report will be submitted.
 
Manufacturer Narrative
H4: the lot was manufactured from september 23, 2021 - september 24, 2021.H10: the actual device was not available; however, a photograph of the sample was provided for evaluation.Visual inspection was performed to the photograph which showed a ruptured bladder.The reported condition was verified.The cause of the condition could not be determined.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
INFUSOR
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 Key15845451
MDR Text Key305613199
Report Number1416980-2022-06405
Device Sequence Number1
Product Code MEB
UDI-Device Identifier00085412022529
UDI-Public(01)00085412022529
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative,Distributor
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 12/27/2022
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 Number2C1009K
Device Lot Number21J045
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 10/31/2022
Initial Date FDA Received11/22/2022
Supplement Dates Manufacturer Received12/15/2022
Supplement Dates FDA Received12/27/2022
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
FLUOROURACIL; NORMAL SALINE
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