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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 Infusion or Flow Problem (2964)
Patient Problem Dyspnea (1816)
Event Type  Injury  
Manufacturer Narrative
The customer reported this event to the fda through medwatch mw5090868. (b)(4). Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported during a patient home infusion with a clearlink solution set, the patient experienced shortness of breath. The patient was admitted to the hospital for the event. Treatment for the event was not reported; however, the patient was continued on the home dose and regimen. It was reported the patient desaturated requiring rapid response and transfer to the intensive care unit (icu). The patient experienced additional episodes that required rapid response and additional transfers in and out of the icu. It was reported the nurse observed that the infusion was not flowing forward at the patient's insertion site. It was noted the infused medication concentration was lower. It was reported the patient stabilized and was able to be transferred out of the icu. It was reported the patient was continued on the home regimen of the medication and no issues were reported. No additional information is available.
 
Manufacturer Narrative
Additional information: 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 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 60073
2242702068
MDR Report Key9503605
MDR Text Key172224658
Report Number1416980-2019-07056
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
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 01/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/20/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number2H8671
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 Received01/10/2020
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

Patient Treatment Data
Date Received: 12/20/2019 Patient Sequence Number: 1
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