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

Model Number 2420-0500

Device Problems Break (1069); Detachment Of Device Component (1104)

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

Event Date 03/01/2018

Event Type  malfunction  

Event Description

Upon hanging iv medication into the alaris 8100 pump, the top part of the iv tubing, that goes into the window with the cassette, broke away from its connector.This is the third occurrence at this facility.Previous report filed.

• 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: 7421132
• MDR Text Key: 105128442
• Report Number: 7421132
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203012430
• UDI-Public: (01)07613203012430
• 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: 03/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 10/14/2020
• Device Model Number: 2420-0500
• Device Catalogue Number: 2420-0500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2018
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/16/2018
• Event Location: Hospital
• Date Report to Manufacturer: 03/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO