MAUDE Adverse Event Report: SIEMENS/CERNER SOARIAN EHR/MDDS

Device Problems Device Alarm System (1012); No Device Output (1435)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 03/25/2016

Event Type  Injury  

Event Description

At our institution, no one is sitting in front of the ehr mdds terminal monitoring the incoming results of every patient, as we do with heart telemetry monitors.Therefore, results come back to the mdds and no one knows that they are there.There is not an alarm or warning; and certainly zero notification of abnormal results.This includes data as vital signs, which have been relegated to a less than vital status by the flawed or absent alarm system in the ehr.In this case, as in many others, vital signs were obtained by machine prompted by techs and these machines send the data to the ehr.The blood pressure was dangerously low, yet the nurse administered three medications that lower blood pressure.The blood pressure decreased further requiring intervention and a increased length of stay.There have been other incidents of disease critical vital signs being deposited in the ehr without the awareness of the clinicians, including a case of what turned out to be (b)(6), when the patient was discharged despite a markedly elevated temperature (and ultimately died, and caused (b)(6) in additional primary and derivative expenses).

• Brand Name: SOARIAN EHR/MDDS
• Type of Device: SOARIAN EHR/MDDS
• Manufacturer (Section D): SIEMENS/CERNER; kansas city MO 64117
• MDR Report Key: 5537445
• MDR Text Key: 41584059
• Report Number: MW5061343
• Device Sequence Number: 1
• Product Code: MWI
• 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: 03/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/25/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention
• Patient Age: 49 YR
• Patient Weight: 81