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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
Model Number 2421-0500
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Apnea (1720); Loss of consciousness (2418)
Event Date 08/27/2019
Event Type  Injury  
Event Description
Infant went apneic. No response to stimulation. Intubated.
 
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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 Key9172708
MDR Text Key161740977
Report Number9172708
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 09/23/2019,09/10/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/09/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number2421-0500
Device Catalogue Number2421-0500
Device Lot Number18018388
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/23/2019
Event Location No Information
Date Report to Manufacturer10/09/2019
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? No
Type of Device Usage

Patient Treatment Data
Date Received: 10/09/2019 Patient Sequence Number: 1
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