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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 J2C1711
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/06/2024
Event Type  malfunction  
Event Description
It was reported that a small volume infusor leaked during filling.Furthermore, ¿saline leaked inside the housing¿.This occurred during compounding.There was no patient involvement.No additional information is available.
 
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Manufacturer Narrative
H4: the lot was manufactured between april 11, 2023 - april 13, 2023.H10: the actual device was received for evaluation.Visual inspection on the returned unit noted fluid contained inside the housing.Further inspection revealed the cause of fluid inside the housing was due to missing upper film-wrap.The upper film-wrap is located at the upper area of the bladder.The upper film-wrap fastens the bladder to the stressmember.When the film-wrap is missing, the bladder does not inflate during fill and the fluid leaks inside the housing.The reported condition was verified.The cause of the missing film-wrap was related to a manufacturing issue.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 Key18830774
MDR Text Key336864498
Report Number1416980-2024-00914
Device Sequence Number1
Product Code MEB
UDI-Device Identifier04987456508334
UDI-Public(01)04987456508334
Combination Product (y/n)N
Reporter Country CodeJA
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 04/03/2024
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 NumberJ2C1711
Device Lot Number23D007
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/06/2024
Initial Date FDA Received03/04/2024
Supplement Dates Manufacturer Received03/17/2024
Supplement Dates FDA Received04/03/2024
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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