MAUDE Adverse Event Report: CAREFUSION ALARIS® PUMP MODULE ADMINISTRATION SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 2429-0500

Device Problem Reflux within Device (1522)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/08/2019

Event Type  malfunction  

Manufacturer Narrative

The customer's complaint of back flow into the secondary could not be confirmed because the product was not returned for failure investigation.The root cause of this failure was not identified.

Event Description

Customer advocacy received a copy of the customer's medwatch report from the fda which states, "patient had a secondary medication attached to primary tubing and a pump.The patient did not receive the medication and it is either an issue with the medication tubing or the infusion pump.The medication in the secondary bag filled up with more fluid so unsure what dose of medication the patient received.Alaris pump from cardinal health, model# 8015, lot# 2013-8, serial# (b)(4), catalog# 10019205".There was no harm.

• Brand Name: ALARIS® PUMP MODULE ADMINISTRATION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer (Section G): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer Contact: stephen bilello ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 8453140
• MDR Text Key: 139897179
• Report Number: 9616066-2019-00856
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403228018
• UDI-Public: 10885403228018
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2021
• Device Model Number: 2429-0500
• Device Catalogue Number: 2429-0500
• Device Lot Number: 18085692
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/15/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 8100,8015,72213N, TD (B)(6) 2019