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

Model Number 2426-0007

Device Problems Device Displays Incorrect Message (2591); Material Deformation (2976)

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

Event Date 04/15/2019

Event Type  malfunction  

Event Description

Pump tubing was primed, and placed into pump to infuse to the pt.The clamps were open when infusion started.After medication infusing into pt's picc, the pump started to alarm for "channel error".The rn opened the pump channel door to find a balloon effect had developed in top tubing segment that gets locked into the channel.Pump and channel used for pt care were evaluated by clinical engineering.No defects or concerns found from the pump malfunctioning.Fda safety report id# (b)(4).

• Brand Name: BD ALARIS PUMP FUSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION, 303 INC.
• MDR Report Key: 8531541
• MDR Text Key: 142734613
• Report Number: MW5085995
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/19/2022
• Device Model Number: 2426-0007
• Device Catalogue Number: 2424-0007
• Device Lot Number: (10) 19016336
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Weight: 81