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

Model Number	2429-0500
Medical Device Problem Code	Reflux within Device (1522)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/08/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8453140
• Report Number: 9616066-2019-00856
• Device Sequence Number: 19524436
• Product Code: FPA
• UDI-Device Identifier: 10885403228018
• UDI-Public: 10885403228018
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K944320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/04/2019

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 8100,8015,72213N, TD (B)(6) 2019