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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 2C9961KP
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/31/2024
Event Type  malfunction  
Manufacturer Narrative
E1: initial reporter address: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that a large volume multirate infusor leaked from the reservoir.This occurred during patient infusion.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
 
Manufacturer Narrative
H4: device manufacture date: the devices were manufactured between 30jun2023 and 05jul2023.H10: the device was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Leak testing was performed by filling the bladder with green color water to a nominal volume.Immediately after fill, a leak was observed originating at one side of the bladder crimp.The reported condition was verified.The cause of the event was due to a manufacturing issue.A nonconformance has been opened to address this 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 Key18818682
MDR Text Key336760256
Report Number1416980-2024-00883
Device Sequence Number1
Product Code MEB
UDI-Device Identifier00085412081502
UDI-Public(01)00085412081502
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K011317
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 05/16/2024
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 Number2C9961KP
Device Lot Number23F019
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 Received03/01/2024
Supplement Dates Manufacturer Received03/21/2024
Supplement Dates FDA Received05/16/2024
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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