FDA Adverse Event Summary report: N

BABYTHERM 8004

MDR report key: 1935546 · Received December 16, 2010

Report

Report Number
1935546
Date Received
December 16, 2010
Date of Event
October 10, 2010
Report Date
December 16, 2010
Manufacturer
DRAEGER
Product Code
FMT
Report Source
User Facility report
Reporter Location
UT, US

Narratives

Description of Event or Problem · 1

NURSING REPORTED THE FOLLOWING. TEMPERATURE PROBE CONNECTED TO PATIENT AND BED AND TEMP SETTINGS SET TO 36.5. OPEN WARMER SHOWED PATIENT'S TEMP AT 37.3, BUT STILL WITHIN NORMAL LIMITS. HEART RATE WAS HIGH SO TEMPERATURE WAS CHECKED RECTALLY WHICH SHOWED A TEMP OF 39.0. PATIENT'S TEMPERATURE SHOULD HAVE BEEN REGULATED CORRECTLY WITH OPEN WARMER BEING CONNECTED TO PATIENT THROUGH TEMPERATURE PROBE. THE INFANT WAS REMOVED AND PLACED IN ANOTHER WARMER; MONITORED VITAL SIGNS CLOSELY.IT WAS DETERMINED THAT THIS OVERHEATING WAS CAUSED BY A KNOWN PROBLEM REFERRED TO AS THE STEM EFFECT. (TECHNICAL INFORMATION AVAILABLE HERE HTTP://BIT.LY/EB6NZI)OUR CURRENT POLICY IS TO COIL THE TEMPERATURE PROBE TO AVOID THE EFFECTS OF THE STEM EFFECT. OUR POLICY IS AS FOLLOWS.THERMOREGULATION FOR ALL PATIENTS ADMITTED INTO RADIANT WARMERS AND INCUBATORS:1. WARM BED PRIOR TO ADMISSION. SEE CPG TABLE NEUTRAL THERMAL ENVIRONMENT FOR TEMPERATURE RANGE TO SELECT. (THIS REQUIRES WEIGHT AND AGE OF PATIENT)2. SELECT PROPER SKIN TEMP PROBE.3. FOR LOW-BIRTHWEIGHT PATIENTS AND THOSE WITH FRAGILE SKIN, PLACE A BARRIER OF DUODERM BETWEEN THE TEMP PROBE COVER AND PATIENT SKIN.A) CUT THE DUODERM INTO A CIRCLE. CUT OUT THE CENTER PORTION. PLACE THIS AGAINST THE SKIN.B) PLACE THE TEMP PROBE INTO THE CENTER OF THE DUODERM AGAINST THE SKIN.C) MAKE A FEW COILS OF THE TEMP PROBE WIRING UNDER THE TEMP PROBE COVER, AND PLACE THIS COVER OVER THE DUODERM.4. FOR PATIENTS WITHOUT SPECIALIZED SKIN CARE NEEDS, PLACE THE TEMPERATURE PROBE AND COILS OF WIRING ON THE STICKY SURFACE OF THE TEMPERATURE PROBE COVER AND PLACE THIS ON THE PATIENT'S BODY.5. ENSURE THE INCUBATOR/ RADIANT WARMER IS SET TO SKIN CONTROL OR SERVO CONTROL, RATHER THAN AIR TEMPERATURE OR MANUAL.6. ADJUST CONTROL TEMPERATURE TO MAINTAIN BABY WITHIN NORMAL RANGE. MEASURE AXILLARY TEMPERATURES WITH CARES.COILING PREVENTS INADVERTENT COOLING OF THE TEMPERATURE PROBE TIP, AND HELPS TO MAINTAIN A CONSISTENT TEMPERATURE.IMPROPER TECHNIQUE IN PLACING SKIN PROBE CAN CAUSE INADVERTENT OVER HEATING OF THE PATIENT.WE ORIGINALLY FOUND OUT ABOUT THE STEM EFFECT IN 1993. MANUFACTURER WAS INVOLVED AT THAT TIME.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 BABYTHERM 8004 WARMER, INFANT RADIANT FMT DRAEGER BABYTHERM 8004 *

Patients

Seq Age Sex Outcome Treatment
1 10 DAY