FDA Adverse Event Malfunction Summary report: N

INTRAVIA CONTAINER

MDR report key: 3110589 · Received May 3, 2013

Report

Report Number
3110589
Event Type
Malfunction
Date Received
May 3, 2013
Date of Event
March 27, 2013
Report Date
May 3, 2013
Manufacturer
BAXTER HEALTHCARE CORP.
Product Code
FPA
Product Problem
Yes
Report Source
User Facility report
Reporter Location
MO, US
Reporter Occupation
RISK MANAGER

Narratives

Description of Event or Problem · 1

WHILE GENTLY FLICKING THE IV TUBING TO CLEAR THE LINE OF AIR (WHICH WAS CAUSING THE PUMP TO ALARM) THE TUBING BROKE AT THE POINT WHERE IT IS INSERTED INTO THE PUMP, CAUSING A COMPLETE BREAK IN THE INFUSION. LINE TO PATIENT WAS IMMEDIATELY CLAMPED OFF (WHICH WAS 'Y'-LINED INTO TPN TUBING) AND DEFECTIVE TUBING WAS REMOVED AND PRESENTED TO NURSE MANAGER. NO HARM TO THE PATIENT AND CENTRAL LINE WAS NOTED. NURSE MANAGER FOLLOWED UP WITH RN AND THIS IS NOT THE FIRST TIME THIS HAS HAPPENED. MULTIPLE EVENTS WITH PUMP BEEPING "AIR IN LINE" AND WHEN THE RN TOOK THE TUBING OUT OF THE PUMP TO FLICK THE TINY MICROSCOPIC AIR BUBBLES, THE TUBING BROKE. IT BROKE APART AT EITHER THE END OF THE RUBBER PART OF THE TUBING THAT ENTERS OR EXITS THE IV CHAMBER. WE HAVE NOT SEEN THIS ON SYRINGE PUMP TUBING BUT THAT PARTICULAR TUBING IS THE SAME TYPE FROM END TO END. ALL OF THE INCIDENTS HAVE INVOLVED THE PART OF THE TUBING THAT IS CONTAINED INSIDE THE PUMP.THIS OCCURRED TWICE WITH SAME PATIENT AND TWO DIFFERENT TUBING SETS, HOWEVER SAME PRODUCT, DIFFERENT LOT NUMBERS. PATIENT DID NOT EXPERIENCE HARM.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.DEVICE #2IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
193566 INTRAVIA CONTAINER TUBING, FLUID DELIVERY FPA BAXTER HEALTHCARE CORP. * UR11L15175
193567 INTRAVIA CONTAINER TUBING, FLUID DELIVERY FPA BAXTER HEALTHCARE CORP. * UR13A09079

Patients

Seq Age Sex Outcome Treatment
1 8 YR