FDA Adverse Event Malfunction Summary report: N

LEVEL 1 HOT LINE L-70

MDR report key: 16828 · Received July 19, 1994

Report

Report Number
16828
Event Type
Malfunction
Date Received
July 19, 1994
Date of Event
June 13, 1994
Report Date
June 22, 1994
Manufacturer
LEVEL 1 TECHNOLOGIES, INC.
Product Problem
Yes
Report Source
User Facility report
Reporter Location
MA, US
Reporter Occupation
RISK MANAGER

Narratives

Description of Event or Problem · 1

HOT LINE L-70 FLUID WARMING SET.ON JUNE 14, 1994, I SET-UP A "HOTLINE" FLUID WARMER IN THE OR; AS USUAL, I FILLED THE RESERVOIR WITH STERILE WTER AND PLUGGED IN THE WARMING COIL. AT THIS POINT, I LEFT THE ROOM TO SEE THE PATIENT.WHEN I RETURNED TO THE ROOM, THE CIRCULATING NURSE STATED THAT SOME WATER HAD SPILLED AND SHE WIPED IT UP. THE FLOOR APPEARED TO HAVE THE SAME "CHUX" ON IT THAT I PLACED THERE AFTER FILLING THE HOTLINE RESERVOIR AND GETTING A LITTLE WATER ON THE FLOOR. I REFILLED THE RESERVOIR AND CONNECTED THE PATIENT'S IV TO IT. I THOUGHT I SAW SOME AIR BUBBLES IN THE TUBING. BUT ASSUMED THAT I HAD NOT PLUGGED INT HE WARMING COIL COMPLETELY AND THIS WAS THE CAUSE OF ANY WATER LEAK OR AIR BUBBLES.AFTER 1-1.5 HOURS, I NOTICED THE WATER LEVEL IN THE RESERVOIR HAD DROPPED AGAIN; AND, THIS TIME, THERE WAS NO WATER ON THE FLOOR. I CHANGED TO A NEW WARMING COIL AND SAVED THE ORIGINAL. THERE WERE NO OTHER PROBLEMS DURING THE CASE. AFTER CHANGING THE COIL, I SENT ELECTROLYTES AND ARTERIAL BLOOD GASES ON THE PATIENT. THEY WERE NORMAL.AFTER THE CASE, I RAN AN IV OF NORMAL SALINE AND METHYLENE BLUE THROUGH THE ORIGINAL WARMING COIL. NO LEAKING WAS APPARENT, UNTIL I PLUGGED THE COIL BACK INTO THE HOTLINE MACHINE; THEN, I NOTICED A LIGHT BLUE COLOR IN THE RESERVOIR. WITH THE CAP OFF THE PATIENT END OF THE WARMING COIL, WE UNPLUGGED IT FROM THE MACHINE AND NOTED WATER FLOWING OUT THE PATIENT IV PORT (GOING TO THE PATINET END). UPON CLOSE INSPECTION, A COMMUNICATION WAS NOTED BETWEEN THE INNER (IV) LUMEN AND OUTER (WATER BATH) LUMEN. THE RESERVOIR WATER WAS CULTURED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 LEVEL 1 HOT LINE L-70 FLUID WARMING SET LEVEL 1 TECHNOLOGIES, INC. 2DAPR94, 70275, 70299

Patients

Seq Age Sex Outcome Treatment
1 62 YR Other