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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION 303, INC. SMARTSITE; SET, ADMINISTRATION, INTRAVASCULAR
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CAREFUSION 303, INC. SMARTSITE; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 11607704
Device Problems Leak/Splash (1354); Split (2537)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/07/2017
Event Type  malfunction  
Event Description
Iv tubing was noted to have iv fluids dripping from the channel of the iv pump.Upon investigation, there was a slit at the top of the piece that does into the channel.Iv tubing was replaced.No harm to patient or equipment.Magnesium sulfate was being infused.Manufacturer response for iv tubing, smart site infusion set (per site reporter): message left on carefusion customer service line to report incident.(b)(6).Carefusion representative, logged file.Arrangements made to send product to manufacturer for analysis.
 
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Brand Name
SMARTSITE
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
CAREFUSION 303, INC.
1515 ivac way
creedmoor NC 27522
MDR Report Key6743715
MDR Text Key81024553
Report Number6743715
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 Other
Type of Report Initial
Report Date 06/27/2017,07/03/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number11607704
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/27/2017
Event Location Hospital
Date Report to Manufacturer06/27/2017
Initial Date Manufacturer Received Not provided
Initial Date FDA Received07/26/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
ALARIS IV PUMP; NO OTHER THERAPIES
Patient Age27 YR
Patient Weight100
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