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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION 303, INC. SMART SITE INFUSION SET SET, ADMINISTRATION, INTRAVASCULAR

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CAREFUSION 303, INC. SMART SITE INFUSION SET SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 2426-0500
Device Problems Air Leak (1008); Device Displays Incorrect Message (2591)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/31/2016
Event Type  malfunction  
Event Description
Attempting to start angiomax infusion. Smartsite infusion set (ref: (b)(4)) was used. Tubing was primed clean with no air or bubbles. Placed in alaris pump. Air-in-line alarm sounded. Tubing removed from pump and reprimed. Air-in-line alarm sounded again. Tubing moved to new pump and reprimed. Air-in-line sounded again. Tubing moved to third pump and air-in-line alarm sounded again. New smartsite infusion set primed. By this time the 50ml bag of angiomax was empty. New bag of angiomax connected to tubing. Hung using same pump. Bolus and infusion started without difficulty. One bag of angiomax was wasted, approximately $800. 00 and procedure was delayed for approximately 5 minutes trying to get angiomax infusion started. Package and tubing saved.
 
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Brand NameSMART SITE INFUSION SET
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
CAREFUSION 303, INC.
10020 pacific mesa blvd.
san diego CA 92121
MDR Report Key5982876
MDR Text Key55795068
Report Number5982876
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 09/12/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/28/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/01/2016
Device Catalogue Number2426-0500
Device Lot Number16067921
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/12/2016
Event Location Hospital
Date Report to Manufacturer09/12/2016
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

Patient Treatment Data
Date Received: 09/28/2016 Patient Sequence Number: 1
Treatment
SMART PUMP
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