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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 SUN GEL PADS

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PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 ARCTIC SUN GEL PADS Back to Search Results
Catalog Number 317-09
Device Problems Loss of Power (1475); Self-Activation or Keying (1557)
Patient Problems Death (1802); Respiratory Failure (2484); Partial thickness (Second Degree) Burn (2694)
Event Date 10/01/2016
Event Type  Injury  
Manufacturer Narrative
The device was not returned for evaluation; however, a photo of the patient was received. During the visual evaluation of the photo it was not possible to describe any condition of the product that would have contributed to the reported issue since the photo is about the patient. The lot number is unknown; therefore, the device history record could not be reviewed. The instructions for use states the following: ¿do not place arcticgel¿ pads on skin that has signs of ulcerations, burns, hives or rash. While there are no known allergies to hydrogel materials, caution should be exercised with any patient with a history of skin allergies or sensitivities. Due to underlying medical or physiological conditions, some patients are more susceptible to skin damage from pressure and heat or cold. Patients at risk include those with poor tissue perfusion or poor skin integrity due to diabetes, peripheral vascular disease, poor nutritional status or steroid or high dose vasopressor therapy. If accessible, examine the patient¿s skin under the arcticgel¿ pads often; especially those patients at higher risk of skin injury. Skin injury may occur as a cumulative result of pressure, time and temperature. Do not place bean bags or other firm positioning devices under the arcticgel¿ pads. Do not place any positioning devices under the pad manifolds or patient lines. ¿ (b)(4). 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 on (b)(6), small blisters were found on the skin around the outline of the pad when the pad was removed. The water temperature was consistently high (42 degrees c) for a long duration of time (10 hours). The alarms were noted and the device turned itself off. It was stated that the staff admitted that they were not diligent with skin checks because the patient was very sick with numerous other therapies going and the staff was very busy. The patient was on dialysis during the arctic sun treatment. It was also reported that the patient could not be rolled due to his/her condition. It has been reported that the patient passed away on (b)(6). The cause of death was respiratory failure. The patient was on vasopressors. The arctic sun therapy was started with a target temperature of 35, and the patient was managed well. After 24 hours, dialysis was started and the target temperature was increased to 37. The patient's blood was not being warmed on return to the body. The water temp was over 38 degrees for 8 hours and flow rate was on average at 1. 9. The patient was unstable and could not be turned without his stats dropping acutely. The patient had 2 days of arctic sun therapy. It was stated by the facility that the patient was a large man and probably could have used an extra pad. The patient¿s reported death was an incidental element of the patient¿s medical history and is unrelated to the reason for the complaint. There is no indication, report or allegation that the device malfunction was related to the patient's death.
 
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Brand NameARCTIC SUN 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 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 Key6045638
MDR Text Key58018721
Report Number1018233-2016-01448
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K142702
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 10/05/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/20/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number317-09
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/05/2016
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

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