MAUDE MDR 8128826

MDR report key
8128826
Report number
MW5081788
Event key
0
Event type
3
Date received
2018-12-03
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
999
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1MINI-BAG PLUS (MBP)EQUIPMENT LOBORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDICABAXTER HEALTHCARE CORPORATIONLXGI *
2ADD-VANTAGE IVPBSSET, I.V. FLUID TRANSFERUNKLHII *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-12-030

Event Narratives#

D

Patient 1

TO ENSURE MEDICATION SAFETY, IT IS IMPORTANT THAT MEDICATIONS BE SCANNED PROPERLY PRIOR TO ADMINISTRATION. HOWEVER, THE BARCODES ON MINI-BAG PLUS (MBP) AND ADD-VANTAGE IVPBS HAVE CAUSED AN ISSUE WITH THIS PROCESS AT (B)(6) HOSPITAL. APPROPRIATE BARCODE SCANNING BY NURSES ADMINISTERING THESE PREPARATIONS REQUIRE THE SCANNING OF BOTH THE DRUG VIAL AND THE IVPB BAG. THE IVPB BAGS HAVE A WHITE BARCODE THAT MAKES IT DIFFICULT FOR NURSES TO SCAN IF A PT LABEL IS PRESENT ON THE OTHER SIDE. AS A RESULT, A MEDICATION SCAN OVERRIDE OCCURS AND THE MEDICATION ENDS UP NOT BEING PROPERLY SCANNED. FOR EXAMPLE, AN ANALYSIS WAS CONDUCTED TO DETERMINE THE NUMBER OF AMPICILLIN 2 G IN NS 100 ML MBP BAGS DISPENSED OVER A 24 HOUR PERIOD; 33 BAGS WERE DISPENSED IN TOTAL; HOWEVER, 25 BAGS HAD AT LEAST ONE COMPONENT (AMPICILLIN OR NS) NOT SCANNED. OF THE 25 NOT SCANNED, 18 WERE ATTRIBUTED TO THE NS, 9 OF THEM DUE TO THE BARCODE BEING UNREADABLE. TO FIX THIS ISSUE, THE PT LABEL IS TO BE PLACED SIDEWAYS ON THE PRODUCT OR FLAGGED IN ORDER FOR THE BARCODE TO BE SCANNED. ALTHOUGH THIS ALTERATION ALLOWS FOR PROPER BARCODE SCANNING, IT IS MERELY A TEMPORARY FIX. ULTIMATELY, IT WOULD BE BENEFICIAL FOR THE MFR TO CHANGE THE COLOR OF THE BARCODE FROM WHITE TO BLACK. THIS WOULD ALLOW FOR THE PT LABEL TO BE PROPERLY PLACED ON THE OPPOSITE SIDE WHILE THE BARCODE WOULD NOW ABLE TO BE SCANNED, ENSURING THE CORRECT MEDICATION IS GOING TO THE RIGHT PT. MEDICATION ADMINISTERED TO OR USED BY THE PT: NO. ISMP, (B)(6) ACCESS NUMBER: (B)(4).