Summary of MedSun Reports Describing Adverse Events With Thermal Regulating Systems in Pediatric Patients and Related Reference
MedSun: Newsletter #28, September 2008

By Elizabeth Eydelman, Patient Safety Staff, 2008

MedSun has received 9 adverse event reports involving thermal regulating systems associated with 4 manufacturers: Cincinnati Sub-Zero Products, Inc. (7), Arizant Healthcare (1), Augustine Healthcare, Inc. (1), and Maquet Cardiopulmonary (1). The reports were submitted by 3 hospitals between March 2007 and April 2008. The most frequently reported device problem is:
• Leaking (6)

There are no MedSun reports involving a death during this time period. There are 6 reports that list malfunction as the type of adverse event, 2 reports do not list type of adverse event, and 1 report lists “other” as the type of adverse event. Of the reports that list patient problems, the most frequently reported patient problems are:

• Thermal burns/injury (2)
• Decreased body temperature (1)
• Elevated body temperature (1)
• Prolonged surgery (1)

All of the reports featured describe patients in the neonatal intensive care unit (NICU) or pediatric intensive care unit (PICU) of each respective hospital. Of the reports that list patient gender, a total of 7 reports involve female patients and a total of 2 reports involve male patients.

These reports contribute to FDA’s post-market experience and understanding of problems associated with the use of these devices. Skin injury associated with thermal regulating systems may occur due to a cumulative effect of time, temperature, and pressure. Mary Frances D. Pate, author of a chapter 14, Thermal Regulation in Oski's Principles and Practice of Pediatrics (Philadelphia:1999), cautions that when children are cold and have peripheral vasoconstriction, the ability of surface capillaries to dissipate heat is diminished, increasing the risk for bums. Monitoring for patient skin integrity and proper device function are essential for safe and effective use of both water-filled and forced air thermal regulating systems.

[Note: The reports have been edited for clarity]




MedSun Thermal Regulating System Adverse Event Reports received between March 2007 and April 2008
Device Device Identifiers Event Description
CINCINNATI SUB-ZERO PRODUCTS, INC./THERMAL REGULATING SYSTEM Model: 874THE USER FACILITY REPORTED THAT A MAXI THERM LITE BLANKET LEAKED ONTO THE FLOOR. THE BLANKET WAS NOT BEING
USED ON A PT AT THE TIME BUT RATHER WAS SITTING ON TOP OF A PIECE OF EQUIPMENT.
CINCINNATI SUB-ZERO PRODUCTS, INC./THERMAL REGULATING SYSTEM Lot: 7796 THE USER FACILITY REPORTED THAT THE NURSE FOUND THE LINENS AND FLOOR WERE WET. NEW BLANKETS WERE OBTAINED. USER FACILITY REPORTED THAT THE PATIENT'S TEMPERATURE DECREASED APPROXIMATELY 0.1 DEGREE CELSIUS.
CINCINNATI SUB-ZERO PRODUCTS, INC./THERMAL REGULATING SYSTEM Lot: 7796 THE USER FACILITY REPORTED THAT A MAXITHERM LITE BLANKET WAS FOUND LEAKING ONTO THE BEDDING AND FLOOR. THE PATIENT WAS REMOVED AND THE LINENS WERE REPLACED. USER FACILITY ALSO REPORTED THAT THE PATIENT'S TEMPERATURE ROSE SLIGHTLY OUT OF THE PARAMETERS FOR CURRENT WARMING PROTOCOL AND WAS RETURNED TO REQUIRED TEMPERATURE PER PROTOCOL ONCE NEW EQUIPMENT WAS ACQUIRED.
CINCINNATI SUB-ZERO PRODUCTS, INC. and ARIZANT HEALTHCARE, INC. /THERMAL REGULATING SYSTEM Model: 111W/ Model: 505 PATIENT UNDERGOING RESECTION OF LARGE LIVER TUMOR. AFTER SURGERY, PATIENT HAD TWO BURNS ON THE LEFT SHOULDER AND BACK APPROXIMATELY 7 CM IN DIAMETER WHICH REQUIRED SURGICAL DEBRIDEMENT AND FLAP CLOSURE.
Augustine Medical, Inc./ THERMAL REGULATING SYSTEM Model: 500 UPON REMOVING DRAPES, IT WAS NOTED A CIRCULAR WOUND APPROX 3CM IN DIAMETER WITH DEPRESSED AREA IN MIDDLE APPROX 1CM ON LEFT INNER CALF. BAIR HUGGER BLANKET WAS UNDER BODY AND ATTACHMENT HOSE WAS CONNECTED TO BLANKET APPROX 1 FOOT BELOW PATIENTS FEET. DATES OF USE: ONE DAY IN 2007. DIAGNOSIS OR REASON FOR USE: SURGERICAL REPAIR OF CLEFT PALATE.
CINCINNATI SUB-ZERO PRODUCTS, INC./THERMAL REGULATING SYSTEM Lot: 8288 WHILE INFANT WAS ON BODY COOLING, THE BLANKET BEGAN TO LEAK LARGE AMOUNTS OF WATER. THERE WAS AN APPARENT HOLE/LACERATION IN THE BLANKET ITSELF. THE BLANKET IN USE WHEN LEAK OCCURRED WAS MAXI-THERM LITE, CATALOG NUMBER 874 BY CINCINNATI SUB-ZERO. THE BLANKET AND THE BED WERE IMMEDIATELY REPLACED, INFANT TEMPERATURE REMAINED AT RECOMMENDED LEVEL(32.5 C) FOR TREATMENT AFTER CHANGE OUT OF EQUIPMENT OCCURRED.
CINCINNATI SUB-ZERO PRODUCTS, INC /THERMAL REGULATING SYSTEM Lot: 316186 COOLING BLANKET LEAKING.
MAQUET CARDIOPULMONARY/THERMAL REGULATING SYSTEM Model: HCU30 THE HEATER/COOLER FAILED DURING A CARDIOPULMONARY BYPASS PROCEDURE. THE CLINICIANS STARTED TO WARM THE CARDIOPLEGIA SIDE FROM 4 DEGREES CELSIUS. THIS SIDE WARMED UNUSUALLY SLOW. THE TEMPERATURE ONLY REACHED 16 DEGREES CELSIUS AFTER 20 MINUTES. AT THIS POINT THE HEATER/COOLER SOUNDED A CONTINUAL AUDIBLE ALARM, LOCKED OUT THE CONTROLS, AND STOPPED WARMING THE PATIENT. THERE WAS NO VISUAL INDICATION OF THE ALARM. THE UNIT WAS TURNED OFF AND BACK ON AGAIN (RE-BOOTED). THE UNIT WORKED FINE AGAIN, BUT DURING THE BOOT-UP SELF TEST IT CYCLED COLD MOMENTARILY, AND THE PATIENT WAS SUBSEQUENTLY COOLED BY APPROXIMATELY 2 DEGREES CELSIUS. THIS RESULTED IN MORE TIME NEEDED ON CARDIOPULMONARY BYPASS TO CONTINUE WARMING THE PATIENT. THE APPROXIMATE DELAY WAS 10 MINUTES.
CINCINNATI SUB-ZERO PRODUCTS INC/THERMAL REGULATING SYSTEM Model: 874 POST-OPERATIVE INFANT BEING COOLED AND LYING ON MAXI-THERM LITE PEDIATRIC COOLING BLANKET. SUDDENLY BLANKET STARTED TO LEAK AT THE CORNER WHERE TUBING ENTERS BLANKET, SPRAYING WATER OVER PATIENT AND PARENT SITTING AT BEDSIDE.


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