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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION MILLIPORE SOLUTION ADMINISTRATION SETS SET, ADMINISTRATION, INTRAVASCULAR

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BAXTER HEALTHCARE CORPORATION MILLIPORE SOLUTION ADMINISTRATION SETS SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number IVGP010XS
Device Problem Fluid Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/09/2021
Event Type  malfunction  
Manufacturer Narrative
Initial reporter facility name: (b)(6). Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that an administration set leaked. The event was further described as "the leak appeared to come from the filter". The filter was changed and the leak stopped this issue was identified during patient infusion of blinatumimab. There was no report of patient injury or medical intervention associated with this event. No additional information is available.
 
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Brand NameMILLIPORE SOLUTION ADMINISTRATION SETS
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
Manufacturer (Section G)
BAXTER HEALTHCARE - TUNISIA
route de chebbaou
2021oued e
tunis
TS
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 
2242702068
MDR Report Key12624407
MDR Text Key276166516
Report Number1416980-2021-06238
Device Sequence Number1
Product Code FPA
Combination Product (y/n)Y
Reporter Country CodeUK
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberIVGP010XS
Device Lot NumberASKU
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received11/03/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/13/2021 Patient Sequence Number: 1
Treatment
BLINATUMIMAB
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