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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION ALARIS SMARTSITE EXTENSION SET; SET, EXTENSION, INTRAVASCULAR
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CAREFUSION ALARIS SMARTSITE EXTENSION SET; SET, EXTENSION, INTRAVASCULAR Back to Search Results
Model Number 20059E
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/06/2019
Event Type  malfunction  
Manufacturer Narrative
The affected product has been received and the investigation is pending.A follow up report will be submitted once the failure investigation has been completed.
 
Event Description
The reported feedback suggests that there was a leakage.The iv fluids (hartmann solution) was disconnected from the 20059e-0006 extension set, blood began to flow back from the patient and leaked from the plug.
 
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Brand Name
ALARIS SMARTSITE EXTENSION SET
Type of Device
SET, EXTENSION, INTRAVASCULAR
Manufacturer (Section D)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
Manufacturer (Section G)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
Manufacturer Contact
sylvia ventura
10020 pacific mesa blvd
san diego, CA 92121-4386
8586172000
MDR Report Key9528325
MDR Text Key179420243
Report Number9616066-2019-03761
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeAU
PMA/PMN Number
K960280
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 12/06/2019
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
Device Operator Health Professional
Device Model Number20059E
Device Catalogue Number20059E
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/19/2019
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/28/2019
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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