MAUDE MDR 4713787

MDR report key
4713787
Report number
MW5042158
Event key
0
Event type
3
Date of event
2015-04-02
Date received
2015-04-15
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1CPOE/EHR DEVICECPOE/EHR DEVICEPRO TOUCH/KINDREDNSX***

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-04-1501. H; 2. L; 3. R

Event Narratives#

D

Patient 1

THE PATIENT HAS MULTIORGAN FAILURE THOUGH WAS IMPROVING, WEANING FROM THE VENTILATOR, RECOVERING FROM SEPSIS, AND ON 3 DAYS PER WEEK RENAL DIALYSIS. THE PATIENT WAS ORDERED NORMAL SALINE TO RUN AT A RATE OF 75 CC PER HOUR. THIS CPOE ORDER FOR INTRAVENOUS FLUID WAS ENTERED ONE WEEK PRIOR TO THE EVENT, BY A CONSULTANT WHO WAS DOING A PROCEDURE ON THIS PATIENT. THE PATIENT COMPLAINED OF EXACERBATION OF DYSPNEA AND WAS FOUND TO HAVE PULMONARY EDEMA ON CHEST RADIOGRAPHY. ON DETAILED REVIEW OF MAR (MEDICINE LIST), IT WAS DETERMINED THAT THE INTRAVENOUS FLUID FOR THE PROCEDURE WAS NEVER DISCONTINUED AS ITS LISTING IN THE MAR WAS MIDWAY THROUGH MORE THAN A PAGE/SCREEN OF MEDICATIONS AND WAS NOT LISTED IN A CATEGORY HEADED AS "INTRAVENOUS MEDICATIONS AND FLUIDS." BECAUSE THE PATIENT WAS ANURIC, THE FLUID ACCUMULATED IN THE LUNGS, RESULTING IN DETERIORATION OF THE RESPIRATORY FAILURE, REQUIRING MORE DIALYSIS. OVER THE COURSE OF THE WEEK, THE PATIENT RECEIVED 12 LITRES OF EXTRA FLUID BASED ON AN ORDER FROM A SPORADIC CONSULTANT, WHICH WAS MISSED BY SEVERAL PHYSICIANS, NURSES, AND PHARMACISTS, EACH DAY. THE USER INTERFACE WAS FLAWED, OBFUSCATING THE ORDER AMIDST MEDICATION ORDERS, AND THERE WAS A FAILURE OF DECISION SUPPORT REMINDERS.