MAUDE Adverse Event Report: ALLSCRIPTS SUNRISE; CPOE/CDS

Device Problems Improper or Incorrect Procedure or Method (2017); Device Operates Differently Than Expected (2913)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 08/21/2014

Event Type  Injury  

Event Description

Pt had lovenox, aspiring, and warfarin ordered by (b)(4), with notes stating that the lovenox is to be discontinued when the inr measuring warfarin anticoagulation reached aleve of 2.0.The inr had been more than 3.0 for 4 days yet pt continued to receive all three potent drugs.The pt developed gastrointestinal bleeding from the excessive anticoagulation.Despite the (b)(4) and decision support, the doctors, nurses, and pharmacy continued to provide the medications.The system is a failure in that it did not warn off the excessive anticoagulation.

• Brand Name: SUNRISE
• Type of Device: CPOE/CDS
• Manufacturer (Section D): ALLSCRIPTS; raleigh NC 27615
• MDR Report Key: 4045010
• MDR Text Key: 4864035
• Report Number: MW5037920
• 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: 08/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/25/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LOVENOX; WARFARIN; ASPIRIN
• Patient Outcome(s): Hospitalization; Life Threatening; Other
• Patient Age: 49 YR
• Patient Weight: 75