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

Model Number 10404198

Device Problems Break (1069); Detachment Of Device Component (1104); Failure to Prime (1492); Failure to Deliver (2338)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/26/2018

Event Type  malfunction  

Event 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
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION 303, INC.; 10020 pacific mesa blvd.; san diego CA 92121
• MDR Report Key: 7373269
• MDR Text Key: 103560862
• Report Number: 7373269
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403232527
• UDI-Public: (01)10885403232527
• 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: Other
• Type of Report: Initial
• Report Date: 03/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: 10404198
• Device Catalogue Number: 10404198
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/02/2018
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/02/2018
• 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