MAUDE Adverse Event Report: CAREFUSION SMARTSITE INFUSION SET

Device Problems Air Leak (1008); Defective Component (2292); Free or Unrestricted Flow (2945)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/05/2018

Event Type  malfunction  

Event Description

The iv pump was alarming with an "air-in-line" error alarm.After attempting to restart the module, the error alarmed again.Upon opening of the iv cartridge, large amounts of iv fluid were free flowing out of an opening in the defective iv line.

• Brand Name: SMARTSITE INFUSION SET
• Type of Device: SMARTSITE INFUSION SET
• Manufacturer (Section D): CAREFUSION
• MDR Report Key: 7178776
• MDR Text Key: 96959801
• Report Number: MW5074480
• 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: Nurse
• Type of Report: Initial
• Report Date: 01/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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 Age: 42 YR