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U.S. Department of Health and Human Services

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

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CAREFUSION 303, INC. ALARIS SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Device Problem Device Slipped (1584)
Patient Problem No Information (3190)
Event Date 12/16/2015
Event Type  malfunction  
Event Description
The tubing did not clamp off once the chamber of the electronic pump opened.
 
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Brand NameALARIS
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
CAREFUSION 303, INC.
3750 torrey view court
san diego CA 92130
MDR Report Key5453531
MDR Text Key38770390
Report Number5453531
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 12/27/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/23/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/27/2015
Event Location Hospital
Date Report to Manufacturer12/27/2015
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: 02/23/2016 Patient Sequence Number: 1
Treatment
ALARIS PUMP
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