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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 Fluid Leak (1250)
Patient Problem Hypoglycemia (1912)
Event Date 04/28/2021
Event Type  Injury  
Manufacturer Narrative
Mfr site : device manufacturer address 1: (b)(4). Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that after six hours of patient infusion of dextrose 12. 5% at 6 ml/hr using a clearlink set, leakage was observed, and the patient's bed mattress became wet. Subsequently, the patient experienced ¿blood sugar dropped¿ (values not provided). A new bag with the medication was set up. The leak was observed ¿where the flat piece connects to the cylinder of the filter¿. No separation or cracks were observed. It was reported the luer connections were checked prior to use. The cause of the leak was not reported. Treatment for the event was not reported. At the time of this report, the patient outcome was not reported. No additional information is available.
 
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Brand NameCLEARLINK SOLUTION ADMINISTRATION SETS
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
Manufacturer (Section G)
BAXTER HEALTHCARE - CARTAGO
see h10
cartago 30106
CS 30106
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 
2242702068
MDR Report Key11863519
MDR Text Key251949535
Report Number1416980-2021-03090
Device Sequence Number1
Product Code FPA
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K153158
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Pharmacist
Type of Report Initial,Followup
Report Date 06/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/21/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number2H8671
Device Lot NumberR21A30117
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/27/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/23/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/01/2021
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: 05/21/2021 Patient Sequence Number: 1
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