MAUDE Adverse Event Report: CAREFUSION 303, INC; IV TUBING, FLUID DELIVERY

Device Problems Fluid/Blood Leak (1250); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/30/2018

Event Type  malfunction  

Event Description

Iv pump beeping channel error, charge rn noticed liquid dripping from channel on iv, opened channel door and ivf squirted out from iv tubing.Tubing change.There was no injury to patient.

• Type of Device: IV TUBING, FLUID DELIVERY
• Manufacturer (Section D): CAREFUSION 303, INC; 10020 pacific mesa blvd.; san diego CA 92121
• MDR Report Key: 7513723
• MDR Text Key: 108283075
• Report Number: 7513723
• 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: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/09/2018
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 05/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 92 YR