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

Model Number	10404198
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/26/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Collectively over the past week or so we've had 10 infusion sets at issue (see descriptions below).There was no patient harm so there is no patient information in this report.All but item 1 were issues with non-priming capabilities; 3 of which were from emergency room and six were from pediatrics/l&d.Since the reference numbers and id numbers were identical on the saved devices the consensus was to get the fda notified of the trend.1.Pump tubing broke while in emergency patient was in ct.The blue piece snapped right at the end of the infusion.The tubing was not being pulled on in any way; we were in the control room and the pump said infusion complete and then seconds later the tubing snapped loose from the top of pump and shot up in air and dumped the last little bit of abx onto the bed.2, 3, & 4.Many pump tubings in the emergency room have problems with initial priming of line.Free flow does not occur until some pressure is applied to cause the backflow valve to "pop" open internally.5 & 6 from l&d and 7-10 pediatrics with the similar issue: iv tubing would not prime and pump was unable to infuse iv fluids.Pump tubing changed 3 times and pump channel changed twice.N.

• Brand Name: ALARIS, SMARTSITE
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION 303, INC.; 10020 pacific mesa blvd.; san diego CA 92121
• MDR Report Key: 7373269
• Report Number: 7373269
• Device Sequence Number: 1095084
• Product Code: FPA
• UDI-Device Identifier: 10885403232527
• UDI-Public: (01)10885403232527
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/02/2018
• Report Date (Section F): 03/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Nurse
• Device Model Number: 10404198
• Device Catalogue Number: 10404198
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/02/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 03/02/2018