FDA Adverse Event Malfunction Summary report: N

ALSIUS ICY CATHETER

MDR report key: 3951914 · Received July 11, 2014

Report

Report Number
3951914
Event Type
Malfunction
Date Received
July 11, 2014
Date of Event
July 7, 2014
Report Date
July 11, 2014
Manufacturer
ZOLL CIRCULATION, INC.
Product Code
NCX
Product Problem
Yes
Report Source
User Facility report
Reporter Location
UT, US

Narratives

Description of Event or Problem · 1

ICY CATHETER PLACED IN THE FEMORAL ARTERY FOR INTERNAL COOLING OF PATIENT. THIS CATHETER HAS THREE BALLOONS THAT FILL WITH NS AND CIRCULATE BACK TO THE PUMP WHERE IT IS COOLED AND RECIRCULATED. NURSE FOUND THE ICY CATHETER WAS INFUSING FLUID INTO PATIENT INSTEAD OF KEEPING IT IN A LOOPED CIRCUIT DUE TO A HOLD THAT ALLOWED THE LEAKAGE. IT WAS INITIALLY NOTED WHEN THE CIRCULATING BAG OF NS WAS FOUND EMPTY AFTER THE AIR CHAMBER ALARM SOUNDED. THE BAG WAS REPLACED AND WATCHED, WHICH CONTINUED TO DRAIN WITH NO SIGN OF LEAKAGE ON BED OR FLOOR FROM TUBING. AT THIS POINT THE THERMO GUARD MACHINE WAS STOPPED AND THE PHYSICIAN WAS PAGED. THE PHYSICIAN PLACED GUIDE WIRE THROUGH ICY CATHETER, REMOVED THE ICY CATHETER WHILE LEAVING THE GUIDE WIRE IN PLACE, THEN PLACED A NEW ICY CATHETER. NO INJURY TO PATIENT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
407060 ALSIUS ICY CATHETER SYSTEM, HYPOTHERMIA, INTRAVENOUS, COOLING, CATHETER NCX ZOLL CIRCULATION, INC. IC-3893 45214

Patients

Seq Age Sex Outcome Treatment
1 71 YR