FDA Adverse Event Malfunction Summary report: N

PHARMACY CLINICAL WORKSTATION

MDR report key: 1456887 · Received August 5, 2009

Report

Report Number
1456887
Event Type
Malfunction
Date Received
August 5, 2009
Date of Event
May 22, 2009
Report Date
August 5, 2009
Manufacturer
SIEMENS MEDICAL SOLUTIONS USA, INC.
Product Code
LNX
Product Problem
Yes
Report Source
User Facility report
Reporter Location
NC, US
Reporter Occupation
RISK MANAGER

Narratives

Description of Event or Problem · 1

DURING A HOSPITALIZATION, THE PATIENT WAS ON A 250ML BAG IV OF NEOSYNEPHRINE AND 250ML BAG OF IV INSULIN. THE NEOSYNEPHRINE WAS WEANED, BUT LEFT HANGING IN CASE IT WAS NEEDED BEFORE EXPIRATION. A NEW BAG OF INSULIN WAS NEEDED, BUT THE NURSE ACCIDENTALLY HUNG A NEW BAG OF NEOSYNEPHRINE INSTEAD. THIS IS ONE OF 6 SIMILAR EVENTS THAT HAVE OCCURRED SINCE INSTALLATION OF A PHARMACY CLINICAL SOFTWARE LABELING SYSTEM 2 YEARS AGO. THE ERRORS WERE DETECTED AT THE BEDSIDE AND NONE OF THE PATIENTS WERE HARMED AS A RESULT. THE INCIDENTS OCCURRED IN THE CRITICAL CARE AREAS WITH PATIENTS ON MULTIPLE DRIPS. ALL OF THESE IV MEDICATION BAGS WERE LABELED USING THE SAME LABELING SYSTEM AS PROVIDED BY THE PHARMACY CLINICAL SOFTWARE LABELING SYSTEM. THE IV INFUSIONS WERE PREPARED AND LABELED CORRECTLY, BUT THE MEDICATION LABELS CREATED BY THE SOFTWARE LABELING SYSTEM ARE CONTRIBUTING TO ERRORS IN ADMINISTRATION. THE FONT IS SMALL AND UNIFORM. TALL MAN LETTERING OR HIGHLIGHTING IS NOT AVAILABLE. A NEAR MISS OCCURRED WHEN NOREPINEPHRINE WAS ALMOST INFUSED INSTEAD OF EPINEPHRINE. NO SUCH EPISODES HAVE BEEN REPORTED WITH PRE-MIXED IV INFUSION BAGS PREPARED AND LABELED OUTSIDE OF THE ORGANIZATION THAT HAD DRUG NAMES IN VERY LARGE, CLEAR FONT, OFTEN OF ANOTHER COLOR.MANUFACTURER RESPONSE (AS PER REPORTER) FOR COMPUTER SYSTEM FOR MEDICATION LABELING SIEMENS PHARMACY CLINICAL WORKSTATION: THE HOSPITAL HAS BROUGHT THIS TO THE PHARMACY CLINICAL SOFTWARE COMPANY'S ATTENTION. THEY WERE TOLD THEY COULD REQUEST SPECIAL CUSTOMIZATION OR WORK THROUGH A 3RD PARTY VENDOR.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 PHARMACY CLINICAL WORKSTATION PHARMACY ADMINISTRATION SYSTEM LNX SIEMENS MEDICAL SOLUTIONS USA, INC. * *

Patients

Seq Age Sex Outcome Treatment
1 52 YR