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

Model Number	10010761
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/06/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Iv tubing primed adequately, removed the tubing from the alaris infusion pump, the connection distal to the pump segment spontaneously disconnected, requiring immediate replacement with a new yellow stripped microbore set.No obvious reason for the disconnection.

• Brand Name: ALARIS
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION 303, INC.; 10020 pacific mesa blvd.; san diego CA 92121
• MDR Report Key: 7052489
• Report Number: 7052489
• Device Sequence Number: 94171
• Product Code: FPA
• UDI-Device Identifier: 07613203021333
• UDI-Public: (01)07613203021333
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 11/15/2017
• Report Date (Section F): 11/15/2017

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
• Operator of Device: No Information
• Device Model Number: 10010761
• Device Catalogue Number: 10010761
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Other
• Date Report to Manufacturer: 11/15/2017
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Date Report Sent to FDA: 11/15/2017