MAUDE Adverse Event Report: BD/CAREFUSION 303, INC. ALARIS PUMP; PUMP, INFUSION

Device Problem Device Alarm System (1012)

Patient Problem Infiltration into Tissue (1931)

Event Date 11/25/2019

Event Type  Injury  

Event Description

Alaris iv pump occlusion alarm did not alarm resulting in right hand infiltrate on a neonate.Fda safety report id #(b)(4).

• Brand Name: ALARIS PUMP
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): BD/CAREFUSION 303, INC.
• MDR Report Key: 9451097
• MDR Text Key: 170665435
• Report Number: MW5091563
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/06/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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; Required Intervention
• Patient Age: 7 DA
• Patient Weight: 2