MAUDE Adverse Event Report: CAREFUSION 303, INC SMARTSITE; SET, ADMINISTRATION, INTRAVASCULAR

Lot Number C24116E

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem Overdose (1988)

Event Date 10/12/2014

Event Type  malfunction  

Event Description

Pt was on a heparin drip that was started.One hour later the dose was changed and co signed by 2 rn's.The dose was 2037 units/hr running at 20ml/hr.No changes had been made to the pump, line or dose.When in the room around 5 and a half hours later the pump beeped and i was shocked to see that the entire 250ml bag had run out.The pt had possibly received more heparin than ordered.I drew a ptt which came back >200.Heparin was stopped, dr notified.Pump has been sent for maintence to see where the error occurred.

• Brand Name: SMARTSITE
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION 303, INC; 10020 pacific mesa blvd; san diego CA 92121
• MDR Report Key: 4264441
• MDR Text Key: 21243578
• Report Number: 4264441
• Device Sequence Number: 3
• Product Code: FPA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/14/2014
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Lot Number: C24116E
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 99