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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION CLEARLINK CONTINU-FLO SOLUTION ADMINISTRATION SETS SET, ADMINISTRATION, INTRAVASCULAR

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BAXTER HEALTHCARE CORPORATION CLEARLINK CONTINU-FLO SOLUTION ADMINISTRATION SETS SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 2C8571
Device Problem Filling Problem (1233)
Patient Problem High Blood Pressure/ Hypertension (1908)
Event Date 04/03/2021
Event Type  Injury  
Manufacturer Narrative
The customer reported this event to the fda through medwatch (b)(4). Device manufacturer address 1: (b)(4). Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that during a patient infusion of an unspecified vasopressor with a clearlink solution set, the patient experienced a rapidly increasing blood pressure. It was reported the mean arterial pressure went from 70's up to 130's. The nurse reassessed the patient lines and observed ¿the line running vasopressors filter portion had completely run dry¿. The nurse attempted to re-prime the line and upon connecting the line to patient, observed ¿that the vasopressor fluids in filter portion was emptying into patient, essentially giving the patient a bolus¿. Subsequently, the patient's blood pressure increased again to mean arterial pressure in the 130's. The line was then changed to different solution set and no further issues were noted. The patient outcome was reported as ¿the patient eventually returned to vasopressor requirements before event¿. No additional information is available.
 
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Brand NameCLEARLINK CONTINU-FLO 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 Key11870708
MDR Text Key252189058
Report Number1416980-2021-03112
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 Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 07/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/24/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number2C8571
Device Lot NumberASKU
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/01/2021
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 Unkown

Patient Treatment Data
Date Received: 05/24/2021 Patient Sequence Number: 1
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