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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
Model Number 10794983
Device Problems Fluid Leak (1250); Infusion or Flow Problem (2964)
Patient Problem Discomfort (2330)
Event Date 05/25/2021
Event Type  malfunction  
Event Description
Found intravenous (iv) bifuser leaking in patient's bed twice. Changed iv bifuser first time when the bed and iv tubing were found wet, found it to be leaking again about a half hour later. No visible cracking noted. Infant was not receiving ordered fentanyl drip and versed drip because they were leaking into bed. Infant was extremely agitated and thrashing head around. Infant is intubated and was dangerously agitated.
 
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Brand NameALARIS
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
CAREFUSION 303, INC.
10020 pacific mesa blvd.
san diego CA 92121
MDR Report Key11958144
MDR Text Key254856139
Report Number11958144
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/02/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number10794983
Device Catalogue Number10794983
Device Lot Number(10)20105151
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/02/2021
Event Location Hospital
Date Report to Manufacturer06/08/2021
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 Unkown

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