MAUDE Adverse Event Report: CAREFUSION CAREFUSION; SMARTSITE INFUSION SET

Model Number 11607704

Device Problems Leak/Splash (1354); Chemical Spillage (2894)

Patient Problem Chemical Exposure (2570)

Event Date 02/21/2018

Event Type  Injury  

Event Description

The pt had his iv chemotherapy lines hook up to the iv medication pump and had started.Within 5 mins the nurse was called back into the room by the pt because the floor was wet.The nurse observed chemotherapy fluid leaking out of tubing below the level of the pump.Infusion stopped.Chemotherapy spill, precautions initiated.Diagnosis or reason for use: pancreatic adenocarcinoma.

• Brand Name: CAREFUSION
• Type of Device: SMARTSITE INFUSION SET
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd.; san diego CA 92121
• MDR Report Key: 7295870
• MDR Text Key: 101013671
• Report Number: MW5075503
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 02/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/18/2020
• Device Model Number: 11607704
• Device Catalogue Number: 11607704
• Device Lot Number: 17126172
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 60 YR
• Patient Weight: 61