MAUDE Adverse Event Report: EPIC EHR; CLINICAL DECISION SUPPORT

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Date 02/28/2016

Event Type  Injury  

Event Description

The clinical decision support device mitigating drug therapy for all pts has poorly usable functionality such that it pressures the user and defaults to heparin therapy for protection from thrombosis, but fails to consider the frequent situations when the pt is already on an anticoagulant such as warfarin or noacs.It requires a significant amount of clinician time to click the way out of the morass of the flawed decision tree to cancel heparin.It is sufficiently onerous that it is much easier to simply allow the pt to remain over anticoagulated, as was the case in this pt.This puts most pts at higher risk of bleeding events.

• Brand Name: EHR
• Type of Device: CLINICAL DECISION SUPPORT
• Manufacturer (Section D): EPIC; verona WI 53593
• MDR Report Key: 5476570
• MDR Text Key: 39647862
• Report Number: MW5060686
• Device Sequence Number: 1
• Product Code: MMH
• 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: 03/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2016
• 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
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other
• Patient Age: 73 YR
• Patient Weight: 101