MAUDE Adverse Event Report: CAREFUSION; SET, ADMINISTRATION, INTRAVASCULAR

Lot Number 21230007

Device Problems Fluid/Blood Leak (1250); Chemical Spillage (2894)

Patient Problem No Information (3190)

Event Date 12/19/2013

Event Type  malfunction  

Event Description

Out of package failure.Spiked iv fluids and placed on pump.Came back a little later to find iv fluid on the floor.Upon investigation found iv tubing to be leaking at top portion of "stretchy" part that goes into the pump.

• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa road; san diego CA 92121
• MDR Report Key: 3611860
• MDR Text Key: 15263584
• Report Number: 3611860
• Device Sequence Number: 1
• Product Code: FPA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Invalid Data
• Type of Report: Initial
• Report Date: 01/31/2014

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: Invalid Data
• Device Lot Number: 21230007
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/31/2014
• Event Location: Hospital
• Date Report to Manufacturer: 02/07/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/31/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 3 MO
• Patient Weight: 7