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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION SMARTSITE INFUSION SET; SET ADMINISTRATIO, INTRAVASCULAR
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CAREFUSION SMARTSITE INFUSION SET; SET ADMINISTRATIO, INTRAVASCULAR Back to Search Results
Lot Number REF: 11522558
Device Problems Detachment Of Device Component (1104); Leak/Splash (1354)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/12/2018
Event Type  malfunction  
Event Description
Chemotherapy-certified nurse was preparing chemotherapy (carboplatin) for a patient.Carboplatin was prepared in an exacta-mix iv bag, and a "smartsite infusion set" from carefusion (ref: (b)(4)) was attached to the iv bag.Upon priming of the iv infusion line, nurse was squeezing the "drip chamber" section of the infusion line set with light pressure.At this point, as she was applying light pressure to the drip chamber, the line became detached from the drip chamber at the "check valve" end of the infusion set.This resulted in some chemotherapy being spilled onto the floor of the patient's room, wherein special precautions were undertaken to clean up the chemotherapy spill.The carboplatin bag was rendered unusable at this point, and a replacement bag was made.Therapy start date: (b)(6) 2018.Therapy end date: (b)(6) 2018.Diagnosis or reason for use: iv chemotherapy infusion.
 
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Brand Name
SMARTSITE INFUSION SET
Type of Device
SET ADMINISTRATIO, INTRAVASCULAR
Manufacturer (Section D)
CAREFUSION
MDR Report Key7453693
MDR Text Key106591352
Report NumberMW5076651
Device Sequence Number1
Product Code FPA
UDI-Device Identifier10885403232305
UDI-Public(01)10885403232305
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 04/19/2018
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 No Information
Device Lot NumberREF: 11522558
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/23/2018
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
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