Summary of MedSun Reports Describing Adverse Events With Thermal Regulating Systems
MedSun: Newsletter #54, November 2010

Per the code of federal regulations, "A thermal regulating system is an external system consisting of a device that is placed in contact with the patient and a temperature controller for the device. The system is used to regulate patient temperature (1)."

Over the past year, MedSun has received 28 adverse event reports associated with thermal regulating systems manufactured by the following firms: Arizant, Inc., Cincinnati Sub-Zero, Inc., Gaymar Industries, Inc., Medivance, Inc., and Smiths Medical ASD, Inc. The reports were submitted by 17 hospitals between September 2009 and September 2010.

The reported device problems were:
Leaking (e.g. leaking of the water circulating blanket, which is connected to the controller unit) – 4 reports
Temperature issues (such as accidentally programming the controller unit to an unintended setting) – 2 reports
Electrical or overheating issues (with the power cord or other component on the controller unit). – 5 reports
Disconnection (of an accessory from the controller unit) – 1 report
Patient worn garment too tight – 1 report
No device problem noted – 15 reports

None of the reports involved a patient death. The patient outcomes listed below were reported.
• Skin blistering – 10 reports
• Skin reddening – 8 reports
• Decreased heart rate – 1 report
• No harm to patient – 9 reports

Of the reports that listed patient age, 6 had a patient age listed as less than 21 years and 15 had a patient age listed as greater than 21 years. Of the reports that listed patient gender, a total of 9 reports involved female patients and a total of 12 reports involved male patients.

These MedSun reports, in addition to manufacturer, healthcare, and voluntary reports contributed to FDA awareness of the device problems. These MedSun reports may, or may not, be involved in the recall(s) listed.

Over the past year, FDA follow-up with the manufacturer resulted in three recalls and two warning letters issued (details of the warning letters can be found online at: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm219661.htm and http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm217747.htm ).

The following 3 recall(s), are noted to be associated with thermal regulating systems.



Recall 1: Class 2 Recall - BAIR PAWS TEMPERATURE MANAGEMENT SYSTEM MODEL 850 (2)

Date Posted: March 16, 2010
Recall Number: Z-0895-2010
Product: Electri-Cord Manufacturing Corporation
(312 E. Main St., Westfield, PA 16950) AC power cords used with either Bair
Paws Temperature Management Units: Models 850 and 875 Bair Hugger Temperature
Management Units: Models 500/OR, 505, 750 and 775 Indicated for hyper- or hypothermic patients or normothermic patients, for whom induced hyper- hypothermia or localized temperature therapy is clinically indicated. In addition, the temperature management systems can be used to provide patient thermal comfort when conditions exist that may cause patients to become too warm or too cold. The temperature management system can be used with adult and pediatric patients.
Code Information: Part number 502221 Model 90024
Recalling Firm/Manufacturer: Arizant Inc; 10393 W 70th St; Eden Prairie, Minnesota 55344
Reason for Recall: Arizant Healthcare Inc. is initiating a nationwide voluntary recall of 100/110-volt power cords (Arizant part number 502221 Model 90024) attached to its temperature management units and pressure infusion power pack (Bair Paws Temperature Management Units: Models 850 and 875 Bair Hugger Temperature Management Units: Models 500/OR, 505 (Human & Vet.), 750 (Human & Vet) and 775 Ranger
Action: An "Urgent Medical Device Power Cord Recall" letter dated December 17, 2009 was sent to customers. The letter was addressed to Recall Coordinator/Biomed Dept. The letter described the affected product, problem, hazard involved, and action to be taken by customer. The customers are being ask to inspect their temperature management units (as described in FDA's recommendation dated October 19, 2009) and contact the firm with the results of their inspection and provide a contact name via website www.arizant.com/powercords or phone (877) 947-1487. Replacement cords and instructions will be provided to customers based on priority listed in the letter and availability of replacement cords. If the customer does not have the means to make the changes, alternate means will be taken (i.e., an Arizant employee or outside service organizations may be brought in to do the replacements). If you have any questions, please contact the Aziant at (877) 47-1487.
Quantity in Commerce: Total distributed for all devices: 84,537 US, 7,380 OUS.
Distribution: Worldwide Distribution: USA and ARGENTINA, THE BAHAMAS, CANADA, COLOMBIA, COSTA RICA, CUBA, DOMINICAN REPUBLIC, ECUADOR, GERMANY, GUAM, JAPAN, LEBANON, MEXICO, NICARAGUA, PANAMA, PUERTO RICO, QATAR, SAUDI ARABIA, SOUTH KOREA, SURINAME , TAIWAN, TRINIDAD AND TOBAGO, QATAR.


Recall 2: Class 2 Recall - WARM AIR WARMING UNIT (3)

Date Posted: February 04, 2010
Recall Number: Z-0781-2010
Product: FilteredFlo Cardiac Blanket. The
device is used to distribute heated air around a patient (for patient
warming).
Code Information: Product # 82542; Catalog # 542; Lot #: 07279, 07280,
07424 & 08813.
Recalling Firm/Manufacturer: Cincinnati Sub-Zero Products Inc; 2011 Mosteller Rd Cincinnati, Ohio 45241-1528
Reason for Recall: Product is labeled as "Sterile". It was observed that incomplete seals were created in the packaging materials during production. When the seal is compromised, the sterility of the product inside the package cannot be assured.
Action: On November 14, 2009, Cincinnati Sub-zero Products, Inc. (CSZ) sent a recall notification letter and response letter to customers. A second notice dated December 10, 2009 was also issued to customers. Customers were instructed in the notifications to assume the recalled product is not sterile and do not use. CSZ requested all affected product be returned to their firm for replacement. Customers are to complete and return the response letter acknowledging receipt of the recall letter. Direct questions to CSZ by calling Customer Service at 1-800- 989-7373. Customers may also call 1-800-989-7373, extension 3234 or 1-51 3-71 9-3234 for recall instructions. Representatives will be available to take your call from 8:30 a.m. until 4:30 p.m. eastern standard time, Monday through Friday.
Quantity in Commerce: 1,095 Blankets
Distribution: Worldwide Distribution -- United States (AL, AR, AZ, CA, CO, CT, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MT, NC, ND, NE, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI & WV), Canada, France, Germany, Ireland, Israel, New Zealand, Singapore, and The Netherlands.


Recall 3: Class 2 Recall - WarmAir 135 (4)

Date Posted: October 29, 2009
Recall Number: Z-0035-2010
Product: WarmAir 135 Thermal Regulating System.
Catalog Numbers: 86186-115 V, 06186-115 V (sold in the U.S.) and #86185-100 V (not sold in the U.S.). Intended for warming patients before, during and after
surgery, and other specialty procedures.
Code Information: Serial Numbers 994-1350001 to
083-1355822..
Recalling Firm/Manufacturer: Cincinnati Sub-Zero Products Inc; 12011 Mosteller Rd Cincinnati, Ohio 45241-1528
Reason for Recall: The blower on the WarmAir 135 Warming Unit may overheat. Resistance in a connector between circuit board and wiring harness results in excessive heat that may melt connector or deform the outer casing of the blower unit.
Action: The firm sent an "URGENT Medical Device Recall' notice via First Class Mail on 2/16/2009 (Note: the letter is dated 2/13/2009). The notice informs the customers of the potential for the device to overheat and of the 'small number of customer complaints received by CSZ concerning this issue. In addition, the notice asks that the customers inspect their units for signs of discoloration indicative of a faulty connector. In the notice, the customers were instructed to return the product to CSZ for repair by contacting their Customer Service division and obtaining a Return Authorization number and specific instructions concerning packaging and returning of the unit(s) for repair. The customer is also instructed to complete the attached Recall Response Form which accompanies the recall notification. The notification provides that customer with a toll-free number at (800) 989-7373ext.3234 or call collect at (513) 719-3234 to reach CSZ representative between the hours of 8:30 a.m. until 4:30 P.M. Monday through Friday EST. Once the customer ships the recalled unit to CSZ, the firm will repair the unit(s) using new connectors manufactured, after which time, the repaired unit is returned to distribution for customer use.
Quantity in Commerce: 2,674 units
Distribution: Nationwide Distribution -- DE, TX, PA, NJ, LA, MI, GA, MA, OH, KY, NY, FL, NV, NC, MT, RI, WA, MN, AL, CT, MD, TN, UT, VA, CO, MO, IA, AZ, AR, IN, NE, KS, WI, ME, MS, and Puerto Rico.

The following table lists the MedSun reports that are described in the device problem summary above.
[Note: The reports have been edited for clarity]

* Indicates information was not available

Adverse Event Table
DeviceCatalog #, Model #, Lot # Event Description
Arizant Healthcare Bair Hugger *,505,* Large rectangular erosion of back status post epidermal loss. Based on localized, rectangular morphology this is most consistent with an extrinsic thermal, ultraviolet radiation, or chemical factor that has led to epidermal necrosis and subsequent blister formation. ====================== Health Professional's Impression ====================== First report was that the burn was caused by a Arizant Bair Hugger ====================== Manufacturer response for Hyperthermia Unit, Forced Air, Bair Hugger (per the site reporter): ====================== Issue is around using these units on pediatric patients. In conversations with Arizant rep, they indicated that this unit should not be used on high. I asked if there was any labeling that they had to indicate this and they do not. The concern is that the unit could reach 56 degrees centigrade without shutting off. The particular piece of equipment that was used on the patient was not identified. All units in surgery were evaluated and determined to meet manufacturer specifications. My immediate concern is that these units have a maximum setting of 43 Degrees C. If the unit has a fault and continues to heat, it can reach 56 Degrees C. I believe this temperature is unsafe for infant/pediatric patients. There needs to be labeling by the manufacturer warning of using higher temperatures, or specific devices manufactured for this type of patient.
Arizant Healthcare Bear Paws *,*,* Staff reported several instances of patients having red 'splotches' on anterior skin surfaces when the Bear Paws Flex gown is removed following surgery. Information in this report refers to the latest incident, when it was reported that the gowns were being removed from service pending investigation. Prior instances were not able to be identified and verified. Details in this case: Pt used gown in holding area with Bear Paws machine. In OR, switched to Bear Hugger. Temp set on high (std practice). Length of procedure approx 2 1/2 hours. When gown removed at the end of the procedure, red splotchy areas were noted on the patients lower abdomen, left groin and left anterior thigh. The hose was found properly connected to the gown. There were no blisters noted. The areas were painless. They faded after approximately 8 hours without treatment.
Arizant Healthcare Bear Paws Flex Ref 81003, 810, GU1025 Staff reported several instances of patients having red 'splotches' on anterior skin surfaces when the Bear Paws Flex gown is removed following surgery. Information in this report refers to the latest incident, when it was reported that the gowns were being removed from service pending investigation. Prior instances were not able to be identified and verified. Details in this case: Pt used gown in holding area with Bear Paws machine. In OR, switched to Bear Hugger. Temp set on high (std practice). Length of procedure approx 2 1/2 hours. When gown removed at the end of the procedure, red splotchy areas were noted on the patients lower abdomen, left groin and left anterior thigh. The hose was found properly connected to the gown. There were no blisters noted. The areas were painless. They faded after approximately 8 hours without treatment.
Arizant Healthcare Inc Bair Hugger *,750,* Post operative patient requested warming blanket. Staff covered patient with a warmer blanket attached to an Arizant 750 warmer. Shortly after staff noticed a "hot" smell near the patient. The smell was quickly narrowed down to the 750 warmer and it was removed from use and Biomed was called. On inspection the Biomed found the molded power cord plug charred. The power cord was replaced and the unit tested OK. This is the second occurrence of this problem on units purchased last year. The other unit had cord issues was approx. 3 months ago.
Arizant Healthcare Inc Bair Paws *,875,* This report is for trending. Our device failure rate is over 35% of our inventory/population over the first year of operation. The device fan motor becomes very noisy over time and has the potential to seize and go into an over temp mode. Potential risk for patient harm if this occurs in an oxygen rich environment such as surgery. In our discussions with the manufacturer, they have agreed to swap out the entire unit.
Arizant Healthcare Inc Bear Hugger *,500 OR,* Staff reported several instances of patients having red 'splotches' on anterior skin surfaces when the Bear Paws Flex gown is removed following surgery. Information in this report refers to the latest incident, when it was reported that the gowns were being removed from service pending investigation. Prior instances were not able to be identified and verified. Details in this case: Pt used gown in holding area with Bear Paws machine. In OR, switched to Bear Hugger. Temp set on high (standard practice). Length of procedure approx. 2 1/2 hours. When gown was removed at the end of the procedure, red splotchy areas were noted on the patients lower abdomen, left groin and left anterior thigh. The hose was found properly connected to the gown. There were no blisters noted. The areas were painless. They faded after approximately 8 hours without treatment.
Arizant Inc Bair Paws Flex Standard Warming Gown *,*,* Patient arrived into the PACU from the OR with large area of redness on the upper left thigh, left flank and left abdomen. The Bair Paws Flex gown was used intra-operatively. Area remained red for approximately two hours. No redness or blistering noted the next day.
Arizant Inc. Bair Hugger *,*,* Soon after turning on Bair Hugger, an explosion and flame occurred from the unit. The bair hugger was immediately removed. Patient assessed. No harm to patient. Problem was found to be the power cord/plug. Wires had become dislodged.
Arizant Medical Bair Paw Warmer *,850,* The machine smelled of burning plastic when the unit was turned on. The smell was noticed by the RN when getting ready to use the machine on the patient. The RN did a safety check and discovered the smell. ====================== Health Professional's Impression ====================== Smell of hot burning plastic
Cincinnati Sub zero Maxi therm Lite 876, *, 769042 Patient using Blanketol III with Maxi-therm Lite blanket. Blanket on top of pt noted to be leaking and saturating patient's gown. Nurse noticed that outer coating of blanket appeared to be coming apart. The blanket was saved.
Cincinnati SubZero Blanketrol II *,*,* Infant in NICU receiving hypothermia therapy to minimize brain injury. Infant noted to have a core temperature of less than the expected 33.5C. Infant was assessed. Cooling blanket was assessed and found to be set at "5C Manual." It had not been switched to "33.5C Automatic." Infant's core temperature dropped to 30C. She was re-warmed after blanket was reset to "33.5C Automatic." Infant's heart rate decreased to 69beats per minute (bpm), no dysrhythmias were noted. While reviewing instruction manual for setup instructions, it was noted that the need to switch from "5 Manual" to "33.5C Automatic" was not written clearly.
Cincinnati Sub-Zero Inc MAXI-THERM Pediatric 274, *, 319075 "An out of box" failure with a cooling mattress. A water leak was discovered when setting up for the admission of a critical infant arriving from an outside hospital. The connector was found to be leaking near the end of the hose. Mattress was taken out of use and replaced by new one without incidence.
Cincinnati Sub-Zero Products, Inc Maxi-Therm 274, *, 319075 Hose noted to be leaking small amounts of water at the connection of the black port on the hose to the black port on the pediatric blanket underneath the baby. Blanket and hose changed and set aside for Biomed.
Cincinnati Sub-Zero Products, Inc. Kool Kit 900,*,8614 The ICU experienced several episodes of the hypothermia blankets leaking. Most of the blankets were the top blanket some were bottom blankets. The leak was large on some of the episodes resulting in the whole bed being changed. Health Professional's Impression: The nurses feel it was a defect in the blanket. Manufacturer response for Kit, Hypothermia Blanket, Cool Kit: Manufacturer felt this was user error but there has been no rhyme or reason to the blankets springing a leak. It has been the vest both top and bottom as well as the blanket. It has been at all different times, when initiating, midway through and at the end. Blankets should last 68-72 hours but are lasting anywhere from 12-48 hours. The nurses had an in-service by the rep, so they know how to use the device.
Cincinnati Sub-Zero Products, Inc. Warm Air *,135,* A new warming unit and blanket was being trialed during surgery. Hose to warming blanket was padded with towel and was not directly on the patient's body. At the end of the procedure, the patient's right knee from mid upper right thigh to mid lower calf was reddened. ====================== Health Professional's Impression ====================== Possibly the connection was taped so that the tape/tension tore part of the paper around the connection and therefore air could escape and blow directly on the patient; or the connection came apart and blew directly on patient; and the blanket not able to be checked under sterile drapes during surgery for problems.
Gaymar *,*,* An elderly patient suddenly became unresponsive while driving his truck. The patient underwent CPR and was brought to the hospital. The patient was placed on a hypothermia protocol. Through this protocol, the patient was cooled with cooling maintained for 24 hours. The patient was then rewarmed per protocol for 12 hours. Nursing noted that the patient had blisters on his right posterior calf.
Gaymar *,*,* An elderly patient was admitted after an out of hospital arrest. The patient was placed on hypothermia protocol. Nursing reported that skin was checked every 2 hours underneath the Gaymar wraps during this protocol. During the protocol's cooling process, the skin was noted to be reddened, cool and intact. The patient's skin gradually became edematous and third spacing was noted. During the rewarming process the patient's skin was noted to be reddened, warm and intact. The skin remained edematous with third spacing. After the rewarming process was completed the patient's back was noted to have fluid filled blisters where the Gaymar wraps were located.
Gaymar *,*,* An elderly patient presented to the emergency room in cardiac arrest. The downtime prior to arrest was unknown. The patient was shocked one time prior to arrival. The patient was ordered to be placed on hypothermia protocol. Nursing noted a few circular blisters on the patient's right side/ chest from the hypothermia vest.
Gaymar *,*,* An elderly patient was admitted to the hospital after an out of hospital cardiac arrest. The patient's total down time was not known. three weeks prior to this incident the patient had a prior myocardial infarction (MI). The patient was placed on hypothermia protocol. After the protocol was completed, nursing noted skin break down on the patient's back. There were multiple sores that appeared to be stage I and II blisters.
Gaymar *,*,* The patient was brought to the emergency room in full arrest. Hypothermia protocol was initiated. The Gaymar device was initiated and set point was programmed for 33 degrees. After 24 hours the rewarming process was started via the Gaymar device. The target temperature was set at 37 degrees, a moderate setting. The patient reached normothermic body temperatures over the next 12 hours. Nursing reported multiple blisters on the right leg of the patient.
Gaymar *,*,* The patient presented with a large inferior posterior ST-elevation myocardial infarction. The patient was placed on hypothermia protocol. Orders were received to maintain body temperature between 32 and 34C for 24 hours with the Gaymar cooling device. Upon removal of the Gaymar blanket the patient was noted to have a palm sized burn with open and closed blebs on the right scapular area on the patient's back. The open areas were partial thickness blistered areas on the right side of the back.
Gaymar *,*,* This patient was an accident drowning victim that had been submersed greater than 15 minutes. The patient was brought to the ED with severe acidosis, and probable anoxic brain damage. Orders were received to maintain body temperature between 32 and 34 degrees C for 24 hours with a Gaymar external cooling blanket. When the hypothermia blanket was removed, the patient was noted to have multiple, scattered fluid filled blisters on his back. Some blisters were intact and some had burst.
Gaymar Industries RaprRound DHV 530, *, * Patient had a prolonged cardiac arrest with CPR. Following hypothermia protocol, the apparatus was removed. Patient had a blister over his back matching the pattern of the hypothermia blanket/apparatus. In our discussions with the manufacturer they have suggested that it must have been used incorrectly and was too tight.
Gaymar Industries, Inc. Medi-Therm III *,MTA6900,* A mechanical cooling system was used to treat the patient's high temperature. Subsequently, dark, reddened regions, non-blanchable to bilateral anterior thighs and lower abdomen. Regions are normal temperature to touch. Regions are not increasing, spreading, or changing in shape, color, or temperature.
Medivance Inc. Arctic Sun 2000-02 or 2000-02L, 2000, * Patient had been on Arctic Sun external cooling for management of neurogenic fevers for 6 days. When pt was turned on the evening of the 6th day, RN found a large blister on back and thighs where the cooling pads had been applied. Two days later the injury was described as frostbite and may be full thickness. Follow-up treatment with silvadene and area debrided a few days later. Clinicians are treating it like a burn. Pads used with the Arctic Sun Cooling Device were product # 317-00 Universal Lot# K9E1804 product # 317-09 Large Lot# K9K0502 Pads were discarded at time of incident.
Smiths Medical ASD Inc Equator - level 1 *,EQ 5000,* At the end of procedure, the device was removed from the patient. At the point of the insertion site of the blower to the blanket, the skin was very red and warm to touch. Skin was also red on the entire left upper arm, shoulder, down to the elbow. By the time discharged from recovery room, the redness had completely resolved.
Smiths Medical ASD Inc Equator Level 1 *,EQ-5000,* At conclusion of surgical case, surgeon removed equator warming blanket and a reddened area on left bicep was present. Upon assessing patient after transfer to PACU, the reddened area was decreased in size but still persisted and remained red in color. No complaint of discomfort from patient.
Smiths Medical ASD, Inc.Level 1 Equator *,*,* Warming system placed on patient during surgical procedure and removed at the end of the procedure. The skin proximal to the location of the Level 1 Equator blower was reddened in an area the size of a grapefruit. It is believed the hose was connected to the blanket throughout the procedure, and the case was approx. 2hrs in duration. The patient's body was not touching the hose.
Smiths Medical ASD, Inc.Level 1 Snuggle Warm *,*,* Once an OR procedure was complete, warming blanket were removed. At this time red marks were observed on the leg in the shape of spiral shape like blower hose to blanket. Redness areas dissipated by the time the patient left the OR.
Smiths Medical EQ 5000 *,EQ 5000,* During neuro surgery a burning smell was identified in the Surgery suite. The convection blanket warmer was the cause of this smell. The disposable blanket was also removed from the patient because it showed minimal presence of char on venting holes and other sections. Removed from service and brought in the Biomed Dept.

Additional Information:

1. 21CFR870.5900 Thermal Regulating System. Available online:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=870.5900

2. Class 2 Recall - BAIR PAWS TEMPERATURE MANAGEMENT SYSTEM MODEL 850. Information available online:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=88575

3. Class 2 Recall: WARM AIR WARMING UNIT. Information available online:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=86906

4. Class 2 Recall: WarmAir 135. Information available online:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=79327


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