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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION 303, INC. ALARIS EXTENSION SET SET, ADMINISTRATION, INTRAVASCULAR

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CAREFUSION 303, INC. ALARIS EXTENSION SET SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 10012866
Device Problem Air Leak (1008)
Patient Problem No Information (3190)
Event Date 10/01/2017
Event Type  malfunction  
Event Description
When using lipid filters, we have had air in the filter or distal to the lipid filter.
 
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Brand NameALARIS EXTENSION SET
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
CAREFUSION 303, INC.
120 s. state college, suite 100
brea CA 92821
MDR Report Key7230402
MDR Text Key98662794
Report Number7230402
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 Patient
Type of Report Initial
Report Date 01/16/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/31/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number10012866
Device Catalogue Number10012866
Other Device ID NumberEXTENSION SET 1.2 MICRON LOW
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/16/2018
Event Location Hospital
Date Report to Manufacturer01/16/2018
Was Device Evaluated by Manufacturer? No Answer Provided
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: 01/31/2018 Patient Sequence Number: 1
Treatment
TUBING MAY HAVE BEEN Y'D WITH TPN OR FLUIDS MOST L
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