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

Model Number 2426-0007

Device Problems Break (1069); Component Missing (2306)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/23/2019

Event Type  malfunction  

Event Description

Nurse was preparing iv site to give medication.When the nurse opened the tubing for the medication she removed the blue covering over the pump segment and the tubing broke off at the connection site.In comparing this device to another, it was noted that the small blue ring to hold tubing together was missing.

• Brand Name: ALARIS, SMARTSITE
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd.; san diego CA 92121
• MDR Report Key: 9198388
• MDR Text Key: 162524267
• Report Number: 9198388
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403227998
• UDI-Public: (01)10885403227998
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/25/2019

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: Health Professional
• Device Model Number: 2426-0007
• Device Catalogue Number: 2426-0007
• Device Lot Number: (10)19075742
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/25/2019
• Event Location: Other
• Date Report to Manufacturer: 10/16/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1