MAUDE Adverse Event Report: BECTON DICKINSON AND CO. BD ALARIS PUMP INFUSION SET; IV PUMP TUBING / SET ADMINISTRATION, INTRAVASCULAR

Lot Number (10)19046788

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 06/02/2019

Event Type  malfunction  

Event Description

Bolus iv fluids ordered for pt, new tubing obtained and tried 3 separate channels but kept alarming saying "air-in-line".Changed tubing and problem was resolved.Fda safety report id# (b)(4).

• Brand Name: BD ALARIS PUMP INFUSION SET
• Type of Device: IV PUMP TUBING / SET ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BECTON DICKINSON AND CO. ; franklin lakes NJ 07417
• MDR Report Key: 8687424
• MDR Text Key: 147777471
• Report Number: MW5087249
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403227998
• UDI-Public: (01)10885403227998
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/24/2022
• Device Lot Number: (10)19046788
• 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