FDA Adverse Event Injury Summary report: N

SIEMENS MEDICAL SYSTEMS INC.

MDR report key: 202875 · Received March 17, 1997

Report

Report Number
MW1010972
Event Type
Injury
Date Received
March 17, 1997
Date of Event
January 15, 1997
Report Date
March 14, 1997
Manufacturer
SIEMENS MEDICAL SYSTEMS, INC.
Product Code
IZI
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
UT, US
Reporter Occupation
RISK MANAGER

Narratives

Description of Event or Problem · 1

A PERCUTANEOUS NEPHROLITHOTRIPSY WAS PERFORMED. DURING THIS PROCEDURE SALINE SOLUTION IS FLUSHED INSIDE THE KIDNEY WHILE FIBEROPTICS IS USED TO LOCATE THE KIDNEY STONE. ONCE THE STONE IS LOCATED AN ULTRASONIC LITHOTRIPTOR IS USED TO SMASH THE STONE AND WITHDRAW THE FRAGMENTS VIA SUCTION. SEVERAL HUNDRED MILLILITERS OF SALINE ARE USED FOR EACH EXAMINATION, THE MAJORITY OF WHICH IS COLLECTED AND DISPOSED OF; HOWEVER, WITH THE USE OF SEVERAL DIFFERENT INSTRUMENTS, SOME SALINE IS INADVERTENTLY SPILLED UPON THE FLOOR. THE X-RAY TUBE HEAD IS COVERED WITH A PLASTIC BAG DURING THESE PROCEDURES SO AS TO KEEP THE SALINE SOLUTION FROM ENTERING THE COLLIMATOR. DURING THIS EXAMINATION, WHILE MOVING THE TABLE IN DIFFERENT POSITIONS, THE BAG SLIPPED OFF OF THE COLLIMATOR, ALLOWING SOME OF THE SALINE TO HIT THE COLLIMATOR RESULTING IN SEEPAGE WITHIN. WHEN THE ROOM WAS USED THE FOLLOWING DAY FOR AN ARTERIOGRAM, PART OF THE MANUAL BOLUSING WAS INOPERATIVE. SERVICE INSPECTION FOUND THAT SALINE WAS READILY APPARENT AND HAD COME WITHIN INCHES OF HIGH TENSION WIRING (70,000 - 100,000 VOLT) THAT COULD HAVE RESULTED IN FATALITIES. THE COLLIMATOR HEAD WAS REPAIRABLE AND FURTHER PROCEDURES LIKE THESE HAVE BEEN DISCONTINUED; HOWEVER, CONCERN HAS BEEN RAISED ABOUT PROCEDURES THAT ARE NECESSARY IN THE ANGIO SUITE THAT ALSO HAVE FLUID PRESENCE (IE. BLOOD, STERILE WATER, ETC.).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 SIEMENS MEDICAL SYSTEMS INC. RADIOGRAPHIC/FLUOROSCOPIC UNITS, ANGIOGRAPHIC IZI SIEMENS MEDICAL SYSTEMS, INC. 11 10 803 X2094 NA

Patients

Seq Age Sex Outcome Treatment
1 NA Life Threatening