FDA Adverse Event Other Summary report: N

INTELENCE INTELLIFILL

MDR report key: 3298004 · Received August 15, 2013

Report

Report Number
MW5031482
Event Type
Other
Date Received
August 15, 2013
Report Date
April 26, 2013
Manufacturer
BAXA CORP
Product Code
NEP
Report Source
Voluntary report
Reporter Location
CA, US
Reporter Occupation
PHARMACIST

Narratives

Description of Event or Problem · 1

THIS IS TO REPORT A CONCERN OUR INSTITUTION HAS WITH REGARDS TO BAXA'S INTELLIFILL I.V. AUTOMATED FILLING SYSTEM. WE USE THIS SYSTEM TO PREPARE SINGLE USE SYRINGES FOR THE OPERATING ROOMS AND THE UNITS. UNFORTUNATELY, THE ONLY SYRINGE SIZE THAT CAN BE USED IS 10 ML REGARDLESS OF VOLUME NEEDED, SO ALL PRODUCTS MADE ON THIS MACHINE ARE EXACTLY THE SAME SIZE. ADDITIONALLY, THE LABEL (PLEASE SEE ATTACHMENT) IS AUTOMATICALLY ATTACHED BY THIS SYSTEM AS A "FLAG". IT IS NOT WRAPPED AROUND THE SYRINGE AND CAN ONLY BE READ FROM ONE ANGLE. ADDITIONALLY, SOMETIMES THESE FLAGGED LABELS END UP STICKING TO EACH OTHER, MAKING IT THAT MUCH HARDER TO READ THE LABEL. ANY MANIPULATION TO THE LABEL (LIKE WRAPPING IT AROUND THE SYRINGE) OR ATTACHMENTS OF AUXILLARY LABELS MUST BE MADE MANUAL. THERE ARE NOT MANY OPTIONS (EXCEPT FOR TALL MAN LETTERING, COLOR, ETC.) TO ALLOW FOR VISUAL DIFFERENTIATION OF THE SYRINGES. OUR CONCERN IS THE RISK OF LASA ERRORS AS THE SYRINGES LOOK VERY MUCH ALIKE AND THE MEDICATION NAME CAN ONLY BE READ FROM ONE ANGLE AS COMPARED TO MOST SYRINGES THAT COME FROM MFRS WHERE THE DRUG NAME IS MORE EASILY READ. REPORTER'S RECOMMENDATIONS: NOT MUCH CAN BE DONE. SEPARATE BINS AND CONTAINERS FOR THE SYRINGES, RE-TRAIN PHARMACY STAFF TO NOT "SCAN ONE, ASSUME MANY" (PARX) WITH BUNDLES OF SUCH SYRINGES. WE APPLY STANDARDIZED APSF/ASA OPERATING ROOM SYRINGE DRUG CLASS LABEL COLOR FORMATS FOR OPERATING ROOM SYRINGES, BUT ONLY BLACK ON WHITE FOR NON-OPERATING ROOM SYRINGES, PER ISMP. ISMP MEDICATION ERRORS REPORTING PROGRAM: ISMP, (B)(6). (B)(4).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
395331 INTELENCE INTELLIFILL NONE NEP BAXA CORP

Patients

Seq Age Sex Outcome Treatment
1