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U.S. Department of Health and Human Services

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

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BAXTER HEALTHCARE CORPORATION SOLUTION SETS SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number EMC9618
Device Problems Material Deformation (2976); No Flow (2991)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
The actual device was not available; however, a photograph of the sample was provided for evaluation. A visual inspection was performed to the photograph using the naked eye which observed a kinked tubing under the chamber causing the no flow. The reported condition was verified during initial inspection. The cause of the condition was not determined. Due to the nature of the returned sample no additional testing could be performed. Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that the tubing below the drip chamber of the solution administration set was kinked and could not be reformed which prevents the fluid to flow. This was identified during an unspecified process step. There was no patient involvement. No additional information is available.
 
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Brand NameSOLUTION SETS
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
Manufacturer (Section G)
BAXTER HEALTHCARE - MALTA
a47 industrial estate
marsa
MT
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key10494879
MDR Text Key205707741
Report Number1416980-2020-05469
Device Sequence Number1
Product Code FPA
Combination Product (y/n)Y
Reporter Country CodeTH
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 09/04/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/04/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberEMC9618
Device Lot NumberASKU
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/11/2020
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

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