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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 2C2009K
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
It was reported that two (2) large volume infusors leaked at the white connector.This occurred at the nurse station, prior to patient use.There was no patient involvement.No additional information is available.
 
Manufacturer Narrative
E1: initial reporter postal code: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.
 
Manufacturer Narrative
Additional information: d4, d9, h3, h4, h6, h10 h4: the lot was manufactured between august 31, 2022 - september 1, 2022 h10: two (2) devices were received for evaluation containing fluid in their bladder.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.The bag that contained the units was dry.The outer and inner surfaces of the units were dry.The blue winged cap was observed to be securely tightened without evidence of wetness or leak.A functional leak test was performed by manually adding green color water to the bladder.During fill, no evidence of leak was observed.After fill, the units were being monitored until the next day.The next day, no evidence of a leak was observed.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 Key18812867
MDR Text Key336629499
Report Number1416980-2024-00852
Device Sequence Number1
Product Code MEB
Combination Product (y/n)N
Reporter Country CodeTW
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 Number2C2009K
Device Lot Number22H041
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/29/2024
Supplement Dates Manufacturer Received03/18/2024
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
Treatment
NA.
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