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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION 303, INC. IV TUBING; SET, ADMINISTRATION, INTRAVASCULAR
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CAREFUSION 303, INC. IV TUBING; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Lot Number 1505737
Device Problem Pumping Stopped (1503)
Patient Problems Nausea (1970); Complaint, Ill-Defined (2331)
Event Date 02/10/2016
Event Type  Injury  
Event Description
Patient in for c section.An 18g iv started in l arm on admit.Iv running well, no problems, bolus given for surgery.Iv running well during spinal and after start of surgery, shortly after beginning surgery the iv stopped running.Iv site did not appear red, tender, swollen or infiltrated.Patient nauseated and not feeling well and needing medication.Anesthesia started 20 g iv in l hand.Iv clamped and tubing switched to new iv and opened up, iv still would not run.Fluid drawn from bag and 20g iv flushed easily with no resistance.New set of port tubing brought from floor, primed and hung.Iv running wide open with no problems.
 
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Brand Name
IV TUBING
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
CAREFUSION 303, INC.
3750 torrey view court
san diego CA 92130
MDR Report Key5462702
MDR Text Key39104540
Report Number5462702
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 02/15/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/26/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Expiration Date08/01/2018
Device Lot Number1505737
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/15/2016
Event Location Hospital
Date Report to Manufacturer02/15/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Type of Device Usage N
Patient Sequence Number1
Patient Age32 YR
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