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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION 303, INC IV TUBING, FLUID DELIVERY

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CAREFUSION 303, INC IV TUBING, FLUID DELIVERY Back to Search Results
Device Problems Fluid Leak (1250); Device Displays Incorrect Message (2591)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/30/2018
Event Type  malfunction  
Event Description
Iv pump beeping channel error, charge rn noticed liquid dripping from channel on iv, opened channel door and ivf squirted out from iv tubing. Tubing change. There was no injury to patient.
 
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Type of DeviceIV TUBING, FLUID DELIVERY
Manufacturer (Section D)
CAREFUSION 303, INC
10020 pacific mesa blvd.
san diego CA 92121
MDR Report Key7513723
MDR Text Key108283075
Report Number7513723
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 05/09/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/15/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/09/2018
Device Age1 DY
Event Location Hospital
Date Report to Manufacturer05/09/2018
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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