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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION CLEARLINK SOLUTION ADMINISTRATION SETS; SET, ADMINISTRATION, INTRAVASCULAR
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BAXTER HEALTHCARE CORPORATION CLEARLINK SOLUTION ADMINISTRATION SETS; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 2H8671
Device Problem Filling Problem (1233)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The user facility submitted a medwatch report for this event: mw5090871.(b)(4).Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that a clearlink solution administration set underinfused.This was identified while a patient was receiving an infusion of an unspecified investigational drug.It was further reported that the drug infusion took two hours longer than it should have and the volume of the drug infused was incorrect.There was no patient injury or medical intervention associated with this event.No additional information is available.
 
Manufacturer Narrative
The device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
 
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Brand Name
CLEARLINK SOLUTION ADMINISTRATION SETS
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
MDR Report Key9492073
MDR Text Key172439134
Report Number1416980-2019-06998
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
PMA/PMN Number
K153158
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 01/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/18/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number2H8671
Device Lot NumberASKU
Was Device Available for Evaluation? No
Date Manufacturer Received01/08/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
IV PUMP; UNSPECIFIED DRUG
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