MAUDE Adverse Event Report: ALLSCRIPTS SUNRISE; CPOE

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 06/01/2014

Event Type  No Answer Provided  

Event Description

Several orders for intravenous fluids were active on the patient, simultaneously.One of the orders was for d5 +alcohol 10 percent to be run at 50 cc/hr.The system of devices fails to detect and prevent life threatening absurdity, a serious defect in their design.

• Brand Name: SUNRISE
• Type of Device: CPOE
• Manufacturer (Section D): ALLSCRIPTS
• MDR Report Key: 4114530
• MDR Text Key: 4921691
• Report Number: MW5038290
• Device Sequence Number: 1
• Product Code: JQP
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/16/2014

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: 09/16/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other
• Patient Age: 87 YR
• Patient Weight: 82