FDA.reportPublic FDA data

MAUDE MDR 9865744

MDR report key
9865744
Report number
1416980-2020-01627
Event key
0
Event type
3
Date of event
2020-02-15
Date received
2020-03-23
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Address
25212 W. ILLINOIS ROUTE 120 ROUND LAKE IL 60073 US
Phone
224-224-2242
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1EM2400 DY DISPLAYSYSTEM/DEVICE, PHARMACY COMPOUNDINGBAXTER HEALTHCARE CORPORATIONNEPNA2400-DYNAR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-2301. R

Event Narratives#

N

Patient 1

SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

D

Patient 1

IT WAS REPORTED THE DEXTROSE AND THE STERILE WATER ?INLETS WERE SWITCHED" DURING THE COMPOUNDING OF TOTAL PARENTERAL NUTRITION (TPN) BAGS WITH AN EXACTAMIX AUTOMATED COMPOUNDING DEVICE. DURING TPN ADMINISTRATION, THE NEONATE PATIENT EXPERIENCED ELEVATED BLOOD GLUCOSE LEVELS. SUBSEQUENTLY, THE INFUSION WAS STOPPED MID INFUSION. THE PATIENT WAS TREATED WITH INTRAVENOUS INSULIN (2 SINGLE DOSES, NO FURTHER DETAILS). IT WAS REPORTED THE PATIENT DID NOT EXPERIENCE ANY SIGNS OR SYMPTOMS RELATED TO THE ELEVATED BLOOD GLUCOSE LEVELS. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERED FROM THE EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

N

Patient 1

THE DEVICE WAS NOT RECEIVED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED; HOWEVER, THE COMPOUNDER BLACK BOX DATA WAS EVALUATED. UPON DATA EVALUATION, THERE WAS NO EVIDENCE THAT THE COMPOUNDER OR THE COMPOUNDER SOFTWARE CONTRIBUTED TO THE REPORTED EVENT OF THE PATIENT RECEIVING THE INCORRECT DRUGS VIA SWITCHING OF THE INLETS. THE DATA PROVIDED SHOWED THAT THE BAG PRODUCED BY THIS COMPOUNDER, WITHOUT ANY ENVIRONMENTAL OR PHYSICAL INTERFERENCE, SHOULD HAVE BEEN ACCEPTABLE FOR CLINICAL USE. THE DEVICE FUNCTIONED AS INTENDED FROM WHAT WAS OBSERVED FROM THE BLACK BOX INFORMATION. THE REPORTED CONDITION WAS NOT VERIFIED. IT IS POSSIBLE THAT THE REPORTED EVENT WAS DUE TO A USE ERROR. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.