MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. S.A DE C.V. ALARIS PUMP INFUSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 2420-0007

Device Problems Disconnection (1171); Failure to Infuse (2340); Material Deformation (2976)

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

Event Date 05/28/2019

Event Type  malfunction  

Event Description

Unit director received a note from one of the rns this morning describing issue with from over the weekend.The first was an instance where the portion of the iv tubing that goes inside the iv pump chamber bubbled which would not allow the infusion to run.The second was a situation where iv tubing came apart at the connection point where the flexible tubing that goes in the chamber attaches to the blue knob that seats into the iv pump channel.Fda safety report id# (b)(4).

• Brand Name: ALARIS PUMP INFUSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. S.A DE C.V.
• MDR Report Key: 8671271
• MDR Text Key: 147239878
• Report Number: MW5087123
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 05/31/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2420-0007
• 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 Outcome(s): Other
• Patient Age: 68 YR
• Patient Weight: 56