MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL¿ PADS; ARCTIC GEL PAD

Catalog Number 317-00

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Burn(s) (1757); Skin Tears (2516)

Event Date 12/27/2023

Event Type  Injury  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11: section a through f - the information provided by bd represents all 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 bd.

Event Description

It was reported that the patient experienced a skin adverse event when the arctic gel pads were removed during post-mortem care.The customer stated there were significant looking burns with the top layer of skin gone.They held on to pads for return to bd.The customer explained that the patient¿s skin was severely damaged and shared that it was the upper torso, front of chest, abdomen, and thighs everywhere.They discussed that there was a longer period of rewarming.The device might have been running at a higher temperature for a while, but they didn't think it was enough to burn at that period of time during rewarming.The arctic sun device had been removed from service during an internal investigation.Hx: patient had multisystem organ failure with frail skin.Per follow up via email on 08jan2024, the intensive care unit (icu) clinical manager stated an internal review was being conducted, and no additional information could be provided.Clinical statement: there was no indication or allegation the device contributed to the patient¿s death.Additionally, there was no indication of a device malfunction.Based on the limited information, this event is being submitted as a serious injury.The reported injury could have resulted in permanent impairment of a body function or permanent damage to a body structure, or necessitated medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.

Manufacturer Narrative

The reported event is inconclusive as no sample was returned for evaluation.Although an exact root cause could not be definitively identified, a potential root cause for this type of failure could be placement of pads on unhealthy, unclean skin.However, there was insufficient information to confirm this potential root cause.A device history record (dhr) review could not be completed as the lot number the arctic gel pads was not provided.The instructions for use were found adequate and state the following: ¿ ¿place the pads on healthy, clean skin only.Remove any creams or lotions from patient¿s skin before pad application.¿ ¿ ¿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.¿ ¿ ¿skin injury may occur as a cumulative result of pressure, time and temperature.¿ ¿ ¿possible skin injuries include bruising, tearing, skin ulcerations, blistering, and necrosis.¿ ¿ ¿if accessible, examine the patient¿s skin under the arcticgel¿ pads often; especially those patients at higher risk of skin injury.¿ h11: section a through f - the information provided by bd represents all 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 bd.

Event Description

It was reported that the patient experienced a skin adverse event when the arctic gel pads were removed during post-mortem care.The customer stated there were significant looking burns with the top layer of skin gone.They held on to pads for return to bd.The customer explained that the patient¿s skin was severely damaged and shared that it was the upper torso, front of chest, abdomen, and thighs everywhere.They discussed that there was a longer period of rewarming.The device might have been running at a higher temperature for a while, but they didn't think it was enough to burn at that period of time during rewarming.The arctic sun device had been removed from service during an internal investigation.Per follow up via email on 08jan2024, the intensive care unit (icu) clinical manager stated an internal review was being conducted, and no additional information could be provided.Additional follow ups were attempted via phone on 24-jan-2024 as well as via email on 17-jan-2024 and 24-jan-2024.The icu clinical manager was still unable to provide details.Per additional information received via email on 08-feb-2024, staff at the facility received education in 2022, and education dates are set for this spring and fall due to the reported issue.The facility is unable to provide additional information and no sample is expected back.Clinical statement: there was no indication or allegation the device contributed to the patient¿s death.Additionally, there was no indication of a device malfunction.Based on the limited information, this event is being submitted as a serious injury.The reported injury could have resulted in permanent impairment of a body function or permanent damage to a body structure, or necessitated medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.

Event Description

It was reported that the patient experienced a skin adverse event when the arctic gel pads were removed during post-mortem care.The customer stated there were significant looking burns with the top layer of skin gone.They held on to pads for return to bd.The customer explained that the patient¿s skin was severely damaged and shared that it was the upper torso, front of chest, abdomen, and thighs everywhere.They discussed that there was a longer period of rewarming.The device might have been running at a higher temperature for a while, but they didn't think it was enough to burn at that period of time during rewarming.The arctic sun device had been removed from service during an internal investigation.Per follow up via email on 08jan2024, the intensive care unit (icu) clinical manager stated an internal review was being conducted, and no additional information could be provided.Additional follow ups were attempted via phone on 24-jan-2024 as well as via email on 17-jan-2024 and 24-jan-2024.The icu clinical manager was still unable to provide details.Per additional information received via email on 08-feb-2024, staff at the facility received education in 2022, and education dates are set for this spring and fall due to the reported issue.The facility is unable to provide additional information and no sample is expected back.Clinical statement: there was no indication or allegation the device contributed to the patient¿s death.Additionally, there was no indication of a device malfunction.Based on the limited information, this event is being submitted as a serious injury.The reported injury could have resulted in permanent impairment of a body function or permanent damage to a body structure, or necessitated medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.

Manufacturer Narrative

The reported event is inconclusive as no sample was returned for evaluation.Although an exact root cause could not be determined a potential root cause could be placement of pads on unhealthy, unclean skin.A device history record review was not required as no lot number was provided.The instructions for use were found adequate and state the following: "contraindications: there are no known contraindications for the use of a thermoregulatory system.Do not place arctic gel¿ 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.Warning: do not place arcticgel¿ pads over transdermal medication patches as warming can increase drug delivery, resulting in possible harm to the patient.Cautions: skin injury may occur as a cumulative result of pressure, time and temperature.Possible skin injuries include bruising, tearing, skin ulcerations, blistering, and necrosis.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.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." h11: section a through f - the information provided by bd represents all 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 bd.

• Brand Name: ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL¿ PADS
• Type of Device: ARCTIC GEL PAD
• Manufacturer (Section D): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; suite 200; louisville 80027
• Manufacturer (Section G): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; suite 200; louisville 80027
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 18541957
• MDR Text Key: 333200869
• Report Number: 1018233-2024-00165
• Device Sequence Number: 1
• Product Code: DWJ
• UDI-Device Identifier: 00801741080005
• UDI-Public: (01)00801741080005
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142702
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 317-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/19/2024
• 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 Sequence Number: 1
• Patient Outcome(s): Other