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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION 303, INC. ALARIS, SMARTSITE; SET, ADMINISTRATION, INTRAVASCULAR
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CAREFUSION 303, INC. ALARIS, SMARTSITE; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 37262E
Device Problems Break (1069); Melted (1385); Difficult to Remove (1528)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/05/2020
Event Type  malfunction  
Event Description
Unable to remove cap from female end of carefusion 303 alaris smartsite iv extension set for setup.Cap would not turn and hemostat needed to be used for removal.Only then the cap was removed, but tubing was broken inside and appeared to be melted.This issue also happened with a second set of tubing as well after the first one failed.Both sets are available for inspection by manufacturer.
 
Event Description
Unable to remove cap from female end of carefusion 303 alaris smartsite iv extension set for setup.Cap would not turn and hemostat needed to be used for removal.Only then the cap was removed, but tubing was broken inside and appeared to be melted.This issue also happened with a second set of tubing as well after the first one failed.Both sets are available for inspection by manufacturer.
 
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Brand Name
ALARIS, SMARTSITE
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
CAREFUSION 303, INC.
10020 pacific mesa blvd
san diego CA 92121
MDR Report Key10483233
MDR Text Key205317678
Report Number10483233
Device Sequence Number1
Product Code FPA
UDI-Device Identifier10885403235276
UDI-Public(01)10885403235276
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 08/13/2020,08/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/02/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number37262E
Device Catalogue Number37262E
Device Lot Number(10)200363
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/13/2020
Date Report to Manufacturer09/02/2020
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age28835 DA
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