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U.S. Department of Health and Human Services

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

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CAREFUSION 303 ALARIS, SMARTSITE SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 2420-0500
Device Problems Air Leak (1008); Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/09/2018
Event Type  malfunction  
Event Description
When rn was attempting to clear air bubbles, the tubing snapped apart.
 
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Brand NameALARIS, SMARTSITE
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
CAREFUSION 303
10020 pacific mesa blvd.
san diego CA 92121
MDR Report Key7285195
MDR Text Key100563061
Report Number7285195
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 02/14/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/21/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2420-0500
Device Catalogue Number2420-0500
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/14/2018
Event Location Hospital
Date Report to Manufacturer02/14/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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