MAUDE Adverse Event Report: CAREFUSION ID- INFUSION PUMP

Device Problems Device Alarm System (1012); Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 02/11/2014

Event Type  malfunction  

Event Description

Alaris iv pump had a yellow light but the alarm was not sounding.Iv fluids were not infusing.Pump removed from service.Biomedical checked the pump and the door ajar sensor failed.The settings were nicu greater than 1500 grams.

• Brand Name: ID- INFUSION PUMP
• Type of Device: ID- INFUSION PUMP
• Manufacturer (Section D): CAREFUSION
• MDR Report Key: 3643087
• MDR Text Key: 4209785
• Report Number: MW5034660
• Device Sequence Number: 1
• Product Code: MEB
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/18/2014

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/19/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 1 DA