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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN GEL PADS

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MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN GEL PADS Back to Search Results
Catalog Number 317-09
Device Problem Insufficient Information (3190)
Patient Problems Death (1802); Burn, Thermal (2530); Alteration In Body Temperature (2682); Partial thickness (Second Degree) Burn (2694)
Event Date 05/03/2017
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.
 
Event Description
It was reported that during the rewarm phase of treatment; initiated on a post cardiac arrest patient, the nurse found blister-like thermal injuries along the edges of the leg pads. The complainant stated that the patient was not sedated, the patient's temperature was below the target of 33°c, and the water temperature was 42°c. The complainant reported that when the night-shift nurse performed a skin check on (b)(6) 2017, no skin abnormalities were identified. The day-shift nurse reported that she discovered the blisters during her assessment on (b)(6) 2017 at 8am. Therapy was discontinued after the blisters were found, per the doctor's order. Cavalon spray was used to treat the blisters. The patient's temperature allegedly continued to decrease. It was later reported that the patient expired two hours after therapy was discontinued; however, the patient's death was not related to the device. The cause of death was related to a neurological issue post cardiac arrest. The patient had received the maximum amount of vasopressors that could be administered. The nurse stated that the skin was in good condition before treatment was initiated, and there was no observed shivering from the patient during therapy. Clinical statement: 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.
 
Manufacturer Narrative
The reported issue was inconclusive due to no sample was returned for evaluation. Only case data was received and reviewed by a field assurance engineer. It was found that the device was producing warm water (greater than 40c) for nearly 7 hours as the patient temperature was slowly responding to therapy. The device was operating properly with appropriate inlet pressure and a flow rate. The device was operating properly throughout therapy and did not find any information relevant that may cause the event reported. 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 during the rewarm phase of treatment; initiated on a post cardiac arrest patient, the nurse found blister-like thermal injuries along the edges of the leg pads. The complainant stated that the patient was not sedated, the patient's temperature was below the target of 33°c, and the water temperature was 42°c. The complainant reported that when the night-shift nurse performed a skin check on (b)(6) 2017, no skin abnormalities were identified. The day-shift nurse reported that she discovered the blisters during her assessment on (b)(6) 2017 at 8am. Therapy was discontinued after the blisters were found, per the doctor's order. Cavalon spray was used to treat the blisters. The patient's temperature allegedly continued to decrease. It was later reported that the patient expired two hours after therapy was discontinued; however, the patient's death was not related to the device. The cause of death was related to a neurological issue post cardiac arrest. The patient had received the maximum amount of vasopressors that could be administered. The nurse stated that the skin was in good condition before treatment was initiated, and there was no observed shivering from the patient during therapy. Clinical statement: 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)
MEDIVANCE, INC. ¿ 1725056
321 s taylor ave
louisville CO 80027
Manufacturer (Section G)
MEDIVANCE, INC. ¿ 1725056
321 s taylor ave
louisville CO 80027
Manufacturer Contact
amy gravley
8195 industrial blvd
covington, GA 30014
7707846100
MDR Report Key6595882
MDR Text Key76127115
Report Number1018233-2017-02770
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 other
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/19/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/26/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number317-09
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/08/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/13/2017
Was Device Evaluated by Manufacturer? Yes
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: 05/26/2017 Patient Sequence Number: 1
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