FDA Adverse Event Injury Summary report: N

VIDACARE EZ IO

MDR report key: 1180480 · Received September 29, 2008

Report

Report Number
MW5008484
Event Type
Injury
Date Received
September 29, 2008
Date of Event
September 4, 2008
Report Date
September 29, 2008
Manufacturer
VIDACARE
Product Code
FMI
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
CA, US
Reporter Occupation
PHYSICIAN

Narratives

Description of Event or Problem · 1

THIS WAS THE SECOND CHILD OF AN AUTO VERSUS PEDESTRIAN EVENT. AN ATTEMPT AT PLACING AN EZ-IO DEVICE BY THE PARAMEDIC IN THE FIELD WAS UNSUCCESSFUL DUE TO -PROBABLE- PENETRATION THROUGH THE BONE WITH INFILTRATION INTO THE RIGHT PROXIMAL LEG. MULTIPLE ATTEMPTS AT PERIPHERAL LINES WERE UNSUCCESSFUL SO PHYSICIAN TWO -ME- ATTEMPTED PLACEMENT OF THE EZ-IO-LINE IN THE LEFT LEG WITH INFILTRATION. A SECOND ATTEMPT WAS MADE WITHOUT SUCCESS. A RN WAS ABLE TO GET A PERIPHERAL LINE STARTED AND ALL FURTHER RESUSCITATION OCCURRED THROUGH THAT LINE. THIS CHILD HAD TWO TENSE INFILTRATIONS INTO THE LEG DUE TO THE FAILURES WITH THIS DEVICE. THERE WERE FOUR ATTEMPTS BY THREE PROVIDERS ON TWO CHILDREN NONE OF WHICH WERE SUCCESSFUL. I SUBSEQUENTLY ATTEMPTED USING THE DEVICE ON THEIR TRAINING "LEG" AND FOUND IT VERY DIFFICULT TO FEEL THE "GIVE". IN REVIEWING THE SALES PROCESS THAT HAD OCCURRED WITH THIS DEVICE, I FOUND THAT EACH HOSPITAL THAT ADOPTED IT, WAS BASING THEIR DECISION ON THE PREVIOUS HOSP DECISIONS WITHOUT ANY EXPERIENCE USING THE DEVICE. REVIEW OF THEIR SALES LITERATURE FOUND SPURIOUS ARGUMENTS FOR ITS IMPLEMENTATION "TIMELY", "EASY", "LOWER INFECTION RATE", NONE OF WHICH ARE BORN OUT BY RESEARCH. THIS MAY BE THE GREATEST DEVICE SINCE SLICED BREAD, BUT IT IS BEING PUSHED FOR USES THAT ARE NOT SUPPORTED. DATES OF USE: 2008. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: YES. EVENT REAPPEARED AFTER REINTRODUCTION: YES.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 VIDACARE EZ IO EASY IO FMI VIDACARE

Patients

Seq Age Sex Outcome Treatment
1 2 YR Disability