FDA Adverse Event Injury Summary report: N

INVISION

MDR report key: 1840208 · Received September 15, 2010

Report

Report Number
MW5017470
Event Type
Injury
Date Received
September 15, 2010
Date of Event
September 8, 2010
Report Date
September 15, 2010
Manufacturer
SIEMENS
Product Code
LNX
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
PA, US
Reporter Occupation
PHYSICIAN

Narratives

Description of Event or Problem · 1

SUDDEN VOMITING OF BLOOD NECESSITATED HOSPITALIZATION. HEMATOCRIT WAS ORDERED TO BE DRAWN AND EXAMINED EVERY 6 HOURS 6-12. BY 9:30 AM, THE DAY AFTER ADMISSION, THE MORNING BLOOD WAS HAD NOT BEEN DRAWN. THE PATIENT'S INTERNAL BLEEDING STATUS WAS UNCERTAIN WITHOUT THE MORNING RESULT. IT WAS DETERMINED THAT THERE WAS NOT ANY BLOOD DRAWN ORDER ON THE COMPUTER SYSTEM. WHAT HAPPENED? THE DOCTORS AND NURSES ENTERED THE ORDERS TO THE EHR IN THE ER, BUT THE BLOOD DRAW ORDERS DID NOT GET CONTINUED IN THE HOSPITAL BECAUSE THEY DID NOT CROSS OVER TO THE INPATIENT EHR -THE SAME COMPANY'S SYSTEM- AND POPULATE THE INPATIENT ELECTRONIC ORDERING SYSTEM. ALL ORDERS ENTERED WHEN PATIENTS ARE ER STATUS -OUT PATIENT- ARE TO BE RE-ENTERED UPON AN ADMISSION TO A HOSPITAL WARD. THIS PATIENT HAD STOPPED BLEEDING, CONFIRMED BY THE LATE MORNING BLOOD TEST. WHAT IF THE PATIENT HAD STARTED BLEEDING AT A GREATER RATE? THE DELAYS IN CARE COULD HAVE BEEN READILY EVIDENT. WE HAVE FOUND SIMILAR DELAYS IN CARE TO BE AN INTEGRAL COMPONENT OF THESE ELECTRONIC ORDERING AND COMPUTER COMMUNICATION SYSTEMS AND MUST ESTABLISH PATIENT SAFETY WORK AROUNDS, BEING THAT THERE HAS NOT BEEN INTEREST IN THE SAFETY OF CARE PROVIDED WITH THESE PRODUCTS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 INVISION SOARIAN/INVISION EHR LNX SIEMENS

Patients

Seq Age Sex Outcome Treatment
1 23 YR Life Threatening| O