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

Model Number 10010761

Device Problem Detachment Of Device Component (1104)

Patient Problem No Information (3190)

Event Date 10/06/2017

Event Type  malfunction  

Event 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
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION 303, INC.; 10020 pacific mesa blvd.; san diego CA 92121
• MDR Report Key: 7052489
• MDR Text Key: 92760130
• Report Number: 7052489
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203021333
• UDI-Public: (01)07613203021333
• 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: 11/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 10010761
• Device Catalogue Number: 10010761
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/15/2017
• Event Location: Other
• Date Report to Manufacturer: 11/15/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 58 YR