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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 ARCTIC GEL PADS ARCTIC SUN GEL PADS

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PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 ARCTIC GEL PADS ARCTIC SUN GEL PADS Back to Search Results
Device Problems Loss of Power (1475); Device Displays Incorrect Message (2591); Temperature Problem (3022)
Patient Problems Cardiopulmonary Arrest (1765); Swelling (2091); Skin Inflammation (2443); Alteration In Body Temperature (2682)
Event Type  Injury  
Manufacturer Narrative
The investigation is still in progress. Once the investigation is complete a supplemental report will be filed. The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard. The device was not returned.
 
Event Description
It was reported that during therapy the device produced an alarm 115. The patient was a large, edematous female who was admitted for continuous renal replacement therapy. The patient's temperature was at 98f but dropped to 94f shortly after continuous renal replacement therapy which caused patient to code. Once the patient was stabilized, the doctor ordered that the patient be placed back onto the arctic sun. The patient's temperature was at 98. 2f but began steadily dropping down to 96. 8f. The water temperature was 104f and flow rate was 2. 8lpm. Continuous renal replacement therapy fluid was room temperature. The event log showed alarms 14, 15, and 115 which caused the device to shut off. The nurse said she had been restarting it. Patient temperature 1 (foley probe) was correlating with esophageal probe(not attached to arctic sun), and was within. 2f, 5 pads were in use; and there was no way to warm the renal replacement therapy fluid. A bair hugger was used on the patient; however,the patient was getting too hot. It was later reported that the patients temperature had risen to 97. 2f but the water temperature was still 104f. The nurse was called back by ms&s an hour later and the patient's temperature was 97. 8f and the water temperature was 103. 8f. The importance of skin checks was repeatedly stressed to the staff. There was a significant delay in therapy as 2 days later the patient still had not reached target temperature. A call was placed to nurse (b)(6) on (b)(6) 2016 at which time she stated that the patient was in very poor condition. The patient was on a bair hugger as well as the arctic sun therapy. The arctic sun therapy started late friday night; however, she noticed the blisters on the patient on friday during the day shift, before arctic sun therapy was initiated. The patient was very swollen with third spacing and was on a vasopressor, levophed. The nurse stated that the pads were rubbing the blisters and causing them to pop, and that the patient's skin was very weep. The blisters were only on the patients legs, and none on the chest. The nurse also reported that she had been doing regular skin checks and every time she raised the pads it made the blisters worse. The blisters were treated with a no sting spray which was over the counter.
 
Manufacturer Narrative
The device was not returned for evaluation. The lot number is unknown; therefore, the device history record could not be reviewed. The instructions for use states the following: "directions for use: arcticgel¿ pads are only for use with an arctic sun® temperature management system control module. See operators manual for detailed instructions on system use. Select the proper number, size and style pad for the patient size and clinical indication. However, the rate of temperature change and potentially the final achievable temperature is affected by pad surface area, patient size, pad placement and water temperature range. Best system performance will be achieved by using the maximum number and largest size pads. For patient comfort, the pads may be prewarmed using water temperature control mode (manual) prior to application. Place the pads on healthy, clean skin only. Remove any creams or lotions from patient¿s skin before pad application. Remove the release liner from each pad and apply to the appropriate area. The pads may be overlapped or folded adhesive-to-adhesive to achieve proper placement. The pads may be removed and reapplied if necessary. The pad surface must be contacting the skin for optimal energy transfer efficiency. Place pads to allow for full respiratory excursion. Attach the pad¿s line connectors to the patient line manifolds. Begin circulating water through the pads using either patient temperature control mode (automatic) or water temperature control mode (manual). If the pads fail to prime or a significant continuous air leak is observed in the pad return line, check connections, then if needed replace the leaking pad. Once the pads are primed, assure the flow rate displayed on the control panel is greater than 2. 3 liters per minute, which is the minimum flow rate for a full pad kit. When finished, empty water from pads. Cold temperature increases the adhesiveness of the hydrogel. For ease of removal, leave pads on the patient for approximately 15 minutes to allow the hydrogel to warm. Slowly remove pads from the patient and discard" the information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
 
Event Description
It was reported that during therapy the device produced an alarm 115. The patient was a large, edematous female who was admitted for continuous renal replacement therapy. The patient's temperature was at 98f but dropped to 94f shortly after continuous renal replacement therapy which caused patient to code. Once the patient was stabilized, the doctor ordered that the patient be placed back onto the arctic sun. The patient's temperature was at 98. 2f but began steadily dropping down to 96. 8f. The water temperature was 104f and flow rate was 2. 8lpm. Continuous renal replacement therapy fluid was room temperature. The event log showed alarms 14, 15, and 115 which caused the device to shut off. The nurse said she had been restarting it. Patient temperature 1 (foley probe) was correlating with esophageal probe(not attached to arctic sun), and was within. 2f. 5 pads were in use; and there was no way to warm the renal replacement therapy fluid. A bair hugger was used on the patient; however,the patient was getting too hot. It was later reported that the patients temperature had risen to 97. 2f but the water temperature was still 104f. The nurse was called back by ms&s an hour later and the patient's temperature was 97. 8f and the water temperature was 103. 8f. The importance of skin checks was repeatedly stressed to the staff. There was a significant delay in therapy as 2 days later the patient still had not reached target temperature. A call was placed to nurse (b)(6) on (b)(4) 2016 at which time she stated that the patient was in very poor condition. The patient was on a bair hugger as well as the arctic sun therapy. The arctic sun therapy started late friday night; however, she noticed the blisters on the patient on friday during the day shift, before arctic sun therapy was initiated. The patient was very swollen with third spacing and was on a vasopressor, levophed. The nurse stated that the pads were rubbing the blisters and causing them to pop, and that the patient's skin was very weepy. The blisters were only on the patients legs, and none on the chest. The nurse also reported that she had been doing regular skin checks and every time she raised the pads it made the blisters worse. The blisters were treated with a no sting spray which was over the counter.
 
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Brand NameARCTIC GEL PADS
Type of DeviceARCTIC SUN GEL PADS
Manufacturer (Section D)
PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590
km. 7 carretera internacional
nogales, sonora PA 85621
MX 85621
Manufacturer (Section G)
PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590
km. 7 carretera internacional
nogales, sonora 85621
MX 85621
Manufacturer Contact
janna parks
8195 industrial blvd
covington, GA 30014
7707846100
MDR Report Key5890312
MDR Text Key52620920
Report Number1018233-2016-01095
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K142702
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/19/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/19/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/19/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/19/2016 Patient Sequence Number: 1
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