MAUDE Adverse Event Report: CAREFUSION SMARTSITE INFUSION SET

Model Number	10015294
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/12/2016
Type of Reportable Event	Malfunction
Event or Problem Description
The seal connecting to the spiros from the tubing was defective so chemo leaked on the bed and on the patient.This is a smartsite infusion set used in an alaris pump module that would not lock onto the spiros - actually there are two sets of tubing this happened with - causing leakage of chemo.

• Brand Name: SMARTSITE INFUSION SET
• Common Device Name: INFUSION SET
• Manufacturer (Section D): CAREFUSION; san diego CA
• MDR Report Key: 6102189
• Report Number: MW5066016
• Device Sequence Number: 671921
• Product Code: FRN
• UDI-Device Identifier: 10885403227981
• UDI-Public: 10885403227981
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/11/2016

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 Expiration Date: 08/31/2019
• Device Model Number: 10015294
• Device Lot Number: 16087495
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/11/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 28 MO
• Patient Weight: 12