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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION SMARTSITE ADD ON BURETTE SET; SET, ADMINISTRATION, INTRAVASCULAR
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CAREFUSION SMARTSITE ADD ON BURETTE SET; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 82113E
Medical Device Problem Codes Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 02/03/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Department assistant, post market surveillance for med consumables.The customer's complaint that the tubing cracked and leaked could not be confirmed because the product was not returned for failure investigation.The root cause of this failure was not identified.Although requested, patient demographics not provided.
 
Event or Problem Description
The customer reported that when they squeezed the drip chamber to pull ivig into chamber the burette cracked and leaked a minimal amount of medication while connected to a patient in the pnatl.There was no harm.
 
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Brand Name
SMARTSITE ADD ON BURETTE SET
Common Device Name
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
MDR Report Key8418248
Report Number9616066-2019-00743
Device Sequence Number13845747
Product Code FPA
UDI-Device Identifier07613203009591
UDI-Public7613203009591
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
PMA/510(K) Number
K780130
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 02/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model Number82113E
Device Catalogue Number82113E
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date03/13/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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