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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 02/04/2024
Event Type  malfunction  
Event Description
It was reported that a small volume infusor leaked around the fill port.The expected time of infusion was 46 hours and the leakage occurred after 31 hours of infusion.The device¿s fill volume was around 115ml.This was observed during patient infusion at the hospital.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
 
Manufacturer Narrative
The device was received and is currently awaiting evaluation.Should additional relevant information become available, a supplemental report will be submitted.
 
Manufacturer Narrative
Additional information: h3, h4, h6, h10.H4: the lot was manufactured between april 11-13, 2023.H10: the actual device was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Functional leak testing was performed, and no evidence of leaking was observed.Based on the evaluation result, the infusor device was determined to be conforming product.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
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 Key18816964
MDR Text Key336666712
Report Number1416980-2024-00858
Device Sequence Number1
Product Code MEB
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 03/27/2024
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
Date Returned to Manufacturer02/15/2024
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/05/2024
Initial Date FDA Received03/01/2024
Supplement Dates Manufacturer Received03/10/2024
Supplement Dates FDA Received03/27/2024
Was Device Evaluated by Manufacturer? Yes
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
UNSPECIFIED MEDICATION.
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