MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDFUSION; FILTER, INFUSION LINE

Model Number MXG300152

Device Problem Leak/Splash (1354)

Patient Problem No Information (3190)

Event Date 11/03/2014

Event Type  malfunction  

Event Description

Shortly after arriving on shift i noted a wet area on the floor beneath 2 medfusion 3500 iv syringe pumps.There were two pumps infusing dextrose 25% into a double lumen uvc at 9ml/hr or 4.5 ml/hr per each pump.I discovered a leak in the iv tubing on one of the pumps just above the in-line filter.I stopped the pump immediately.Increased the rate in the other pump to 9ml/hr.I notified the charge nurse and the nurse practitioner.We changed out the tubing and checked a blood glucose level which was within a normal range (66).The tubing with the leak will be turned in to the nurse manager.Im not sure how it could be prevented unless the leak is noted while priming the tubing.The infusion iv tubing was changed.No further leaks noted after replacement of tubing and the nurse practitioner has been advised.

• Brand Name: MEDFUSION
• Type of Device: FILTER, INFUSION LINE
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6250 shier rings rd; dublin OH 43016
• MDR Report Key: 4268343
• MDR Text Key: 20455263
• Report Number: 4268343
• Device Sequence Number: 1
• Product Code: FPB
• 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: 11/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: MXG300152
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/05/2014
• Event Location: Hospital
• Date Report to Manufacturer: 11/21/2014
• Patient Sequence Number: 1
• Patient Age: 1 DAY