Catalog Number 317-07 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hemorrhage/Bleeding (1888); Renal Failure (2041); Septic Shock (2068); Ulceration (2116)
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Event Date 03/08/2017 |
Event Type
Injury
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Manufacturer Narrative
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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.
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Event Description
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It was reported that wounds were found on the patients back and thigh.The wounds were described as ulcerated.The patient was allegedly experiencing septic shock, kidney failure, and gastrointestinal bleeding.; and was also on vasopressors.The pads were removed and replaced with a thermal blanket.It was later reported that the wounds were phlyctena, and purple in color.The wounds were on the back and measured 35 x 1.5.The wounds were nursed with antiseptic.The patient received arctic sun therapy for 4 days, and the target temperature was 37°c.Subsequently, the pads were replaced with a thermal blanket.
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Manufacturer Narrative
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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: ¿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.¿ (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.
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Event Description
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It was reported that wounds were found on the patients back and thigh.The wounds were described as ulcerated.The patient was allegedly experiencing septic shock, kidney failure, and gastrointestinal bleeding.; and was also on vasopressors.The pads were removed and replaced with a thermal blanket.It was later reported that the wounds were phlyctena, and purple in color.The wounds were on the back and measured 35 x 1.5.The wounds were nursed with antiseptic.The patient received arctic sun therapy for 4 days, and the target temperature was 37°c.Subsequently, the pads were replaced with a thermal blanket.
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Search Alerts/Recalls
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