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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 01/31/2023
Event Type  malfunction  
Manufacturer Narrative
Initial reporter facility name: (b)(6) hospital.Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that a large volume infusor elastic fluid bladder "cracked".This was observed during patient infusion.The device was filled with fluorouracil and 0.9% normal saline with a total volume of 240ml.There was approximately 80ml was not infused.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
 
Manufacturer Narrative
H4: the lot was manufactured from manufactured october 20, 2021 to october 21, 2021.H10: the actual device was received for evaluation.A visual inspection on the returned unit with the naked eye noted the bladder had been ruptured.The ruptured bladder was examined for signs of abnormality.There were no signs of abnormality found on the bladder that may have led to the rupture.The reported condition was verified.The root cause could not be determined.A possible root cause for the bladder rupture 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
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 Key16448254
MDR Text Key310345095
Report Number1416980-2023-00696
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,Health Professional,Company Representative
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 03/30/2023
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 Health Professional
Device Catalogue Number2C1009K
Device Lot Number21K028
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/31/2023
Initial Date FDA Received02/27/2023
Supplement Dates Manufacturer Received03/21/2023
Supplement Dates FDA Received03/30/2023
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
Treatment
0.9% NORMAL SALINE; FLUOROURACIL
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