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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION 303, INC. ALARIS, SMARTSITE SET, ADMINISTRATION, INTRAVASCULAR

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CAREFUSION 303, INC. ALARIS, SMARTSITE SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Device Problems Deformation Due to Compressive Stress (2889); Gas Leak (2946)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/24/2020
Event Type  malfunction  
Event Description
Alaris tubing saying air in line, no air in tubing. There was a small kink in the tubing which may have caused the problem. Tubing replaced and issue resolved.
 
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Brand NameALARIS, SMARTSITE
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
CAREFUSION 303, INC.
10020 pacific mesa blvd
san diego CA 92121
MDR Report Key9670581
MDR Text Key177821661
Report Number9670581
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 01/29/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/05/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/29/2020
Event Location Hospital
Date Report to Manufacturer02/05/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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