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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 ARTICGEL PADS ARCTICGEL PADS

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C.R. BARD, INC. (COVINGTON) -1018233 ARTICGEL PADS ARCTICGEL PADS Back to Search Results
Catalog Number 317-09
Device Problem Insufficient Information (3190)
Patient Problems Erythema (1840); Injury (2348)
Event Date 05/18/2017
Event Type  Injury  
Manufacturer Narrative
The reported issue (it was reported that the patient experienced thermal injuries on his thighs in the form of "mild frostbite" after receiving therapy for seven hours. The complainant reported that therapy was initiated at 3:30am, the pads were placed on clean, intact skin, and the injuries were found around 10:30am. The patient's abdomen was allegedly red, and the skin was blanchable; however, his thighs appeared to have "mild frostbite", and the skin was unblanchable. The complainant reported that there had been no alerts or alarms received on the device during therapy. The patient was initially placed on the device post cardiac arrest. The complainant reported that therapy has continued on the patient with the same set of pads. ) was inconclusive. There is no formal way to test the reactions of the patient on the pads. Visual evaluation showed that the appearance of the gel on the pads returned looked normal, there was no alterations or manufacturing deficiencies on the pad surface; the pads were reviewed and found to have the trim pattern correctly performed. The plastic tube was found completely assembled covering the total of clamping rings on the plastic connector and manifold connector. The foams were found free of damages, tears or perforations, the seal between manifold connector and pads were found completely sealed. The energy connectors were found free of damages, the pads were noted with sealing presence. No manufacturing issues related were noted during the visual evaluation of the pads returned. There were no alterations or manufacturing deficiencies on the pads surface. The lot number is unknown; therefore, the device history record could not be reviewed. The instructions for use state the following: "the instructions for use baw28-300130-00 establish the following cautioned: 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. Do not allow urine, antibacterial solutions or other agents to pool underneath the arcticgel¿ pads. Urine and antibacterial agents can absorb into the pad hydrogel and cause chemical injury and loss of pad adhesion. Replace pads immediately if these fluids come into contact with the hydrogel. Do not place arcticgel¿ pads directly over an electrosurgical grounding pad. The combination of heat sources may result in skin burns. Carefully remove arcticgel¿ pads from the patient¿s skin at the completion of use. Aggressive removal or removal of cold pads from the patient¿s skin may result in skin tears. Use pads immediately after opening. Do not store pads in opened pouch. If warranted, use pressure relieving or pressure reducing devices under the patient to protect from skin injury. The water content of the hydrogel affects the pad¿s adhesion to the skin and conductivity, and therefore, the efficiency of controlling patient temperature. Periodically check that pads remain moist and adherent. Replace pads when the hydrogel no longer uniformly adheres to the skin. Replacing pads at least every 5 days is recommended. ¿ also, the ifu baw28-300130-00 rev. 2 indicate 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¿ based on a review of the risk management process and the clinical evaluation report (mtk0046-00) for the system, the possible undesirable side effects (risks) of the arctic sun® temperature management system under normal conditions of use and the identified hazards were found to be acceptable when weighed against benefits to the patient. The individual and cumulative residual risk is acceptable associated with the use of the device has been adequately reduced as far as possible. The appropriate methods are in place to obtain relevant production and post-production information relative to the potential hazards. " (b)(4).
 
Event Description
It was reported that the patient experienced thermal injuries on his thighs in the form of "mild frostbite" after receiving therapy for seven hours. The complainant reported that therapy was initiated at 3:30am, the pads were placed on clean, intact skin, and the injuries were found at approximately 10:30am. The patient's abdomen was allegedly red, and the skin was blanchable; however, his thighs appeared to have "mild frostbite", and the skin was unblanchable. The complainant reported that there had been no alerts or alarms received on the device during therapy. The patient was initially placed on the device post cardiac arrest. The complainant reported that therapy was continued on the patient with the same set of pads.
 
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 the patient experienced thermal injuries on his thighs in the form of "mild frostbite" after receiving therapy for seven hours. The complainant reported that therapy was initiated at 3:30am, the pads were placed on clean, intact skin, and the injuries were found at approximately 10:30am. The patient's abdomen was allegedly red, and the skin was blanchable; however, his thighs appeared to have "mild frostbite", and the skin was unblanchable. The complainant reported that there had been no alerts or alarms received on the device during therapy. The patient was initially placed on the device post cardiac arrest. The complainant reported that therapy has continued on the patient with the same set of pads.
 
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Brand NameARTICGEL PADS
Type of DeviceARCTICGEL PADS
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
Manufacturer (Section G)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
Manufacturer Contact
amy gravley
8195 industrial blvd
covington, GA 30014
7707846100
MDR Report Key6616179
MDR Text Key261533186
Report Number1018233-2017-02962
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,use
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/15/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/06/2017
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 Manufacturer06/12/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/13/2017
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

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