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

Model Number 2420-0500

Device Problem No Flow (2991)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/15/2020

Event Type  Injury  

Event Description

Bd alaris pump infusion set spiked into bag of lrs and attempted to prime.Fluid will not run through the tubing.No visible kinks or blockages.Bag spiked with new tubing working fine.Fda safety report id# (b)(4).

• Brand Name: BD ALARIS PUMP INFUSING SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BD/CAREFUSION 303, INC.
• MDR Report Key: 10612817
• MDR Text Key: 209555656
• Report Number: MW5096977
• Device Sequence Number: 1
• Product Code: FPA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 09/28/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 05/12/2023
• Device Model Number: 2420-0500
• Device Catalogue Number: 2420-0500
• Device Lot Number: (10)20053226
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/30/2020
• 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): Required Intervention