inforMED
MalfunctionFPK

BIFUSE SETSOURCE SMALL BORE

Received Jan 17, 2014 · Event occurred Nov 27, 2013

Report 3596513 · MDR key 3596513

Device

Generic name

Tubing, Fluid Delivery

Manufacturer

Icu Medical Inc

Model number

*

Catalog number

*

Lot number

*

Product problems

  • Improper or Incorrect Procedure or Method
  • Split

Patient

7 YR

  • Overdose

Narrative

Description of Event or Problem

VINCRISTINE CAME FROM THE PHARMACY ATTACHED TO BIFUSE TUBING. TUBING CONNECTED TO PATIENT AND BEGAN PUSHING VINCRISTINE SYRINGE AND VINCRISTINE SPRAYED OUT OF SPLIT IN TUBING. VINCRISTINE NOT DIRECTLY ON PATIENT OR NURSES SKIN. PATIENT'S SWEATER REMOVED. THE DOSAGE IN THE SYRINGE WAS 1.4MG. THIS IS AN ERROR THAT REACHED THE PATIENT AND REQUIRED MONITORING OR INTERVENTION TO CONFIRM THAT IT RESULTED IN NO PATIENT HARM. SYRINGE IS NOT AVAILABLE. WE BELIEVE IT WAS DISCARDED. I WAS ALSO NOT ABLE TO FIND ANY PRODUCT IDENTIFIERS. I WENT INTO THE PATIENT'S CHART AND THERE WAS NO ADDITIONAL INFORMATION INDICATED.