MAUDE Adverse Event Report: PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 ARCTIC GEL PADS; ARCTIC SUN GEL PADS

Catalog Number 317-09

Device Problem Device Displays Incorrect Message (2591)

Patient Problems Bradycardia (1751); Death (1802); Low Blood Pressure/ Hypotension (1914); Tissue Damage (2104); Excessive Tear Production (2235); Cardiogenic Shock (2262)

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 there was a low flow.The patient had completed the rewarm phase of therapy.The patient's temperature was 36.4°c, with a water temperature of 35.2°c, and a flow rate of 2.1lpm.The nurse reported an alarm/alert for prolonged hot water exposure, and that the patient had blisters and peeling skin on their thighs and torso in areas under the pads.The patient weighed (b)(6), and was fitted with 4 large pads.The event log revealed 2 alarm 115's on (b)(6) 2017.One alarm was at 6:10am, and one was at 10:05am.There was also an alert 02 from (b)(6) 2017.The nurse was then advised to cease therapy, evaluate the patient's skin and treat any injuries per protocol.Case data was also requested.In a follow up call 1 hour later, the nurse reported that the patient was terminal with very poor circulatory status.The patients blood pressure was 57/30 and heart rate was 20bpm.The patient expired at approximately 1pm on (b)(6) 2017 due to natural causes.The nurse reported that the death was due to the patient's condition, and did not allege the death against the device.It was later reported that the patient was on vasopressors.Therapy was discontinued after a large skin tear on the right thigh and skin tears on the torso were found.There was blistering on the back and red skin on the edges of the pads.The facility stated that there protocol was to perform skin checks every 4 hours.The nurse stated that there was no treatment of the skin, due to the patient's condition.The patient died hours after treatment was stopped due to natural causes.The cause of death was reported as cardiogenic shock.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 unconfirmed.During the visual evaluation, the appearance of the gel in the pad looked normal, and there was no alterations or manufacturing deficiencies on the pad surface that would have contributed to the reported problem.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 foam was found free of damages, tears or perforations, the seal between manifold connector and pads were found completed sealed, the energy connectors were found free of damages, and the pads were noted with sealing presence.No manufacturing issues related were noted during the visual evaluation of the pads returned.There are no alterations or manufacturing deficiencies on the pads surface that would have contributed to the reported problem.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use states the following: ¿¿ 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.

Event Description

It was reported that there was a low flow.The patient had completed the rewarm phase of therapy.The patient's temperature was 36.4°c, with a water temperature of 35.2°c, and a flow rate of 2.1lpm.The nurse reported an alarm/alert for prolonged hot water exposure, and that the patient had blisters and peeling skin on their thighs and torso in areas under the pads.The patient weighed (b)(6), and was fitted with 4 large pads.The event log revealed 2 alarm 115's on (b)(6) 2017.One alarm was at 6:10am, and one was at 10:05am.There was also an alert 02 from (b)(6) 2017.The nurse was then advised to cease therapy, evaluate the patient's skin and treat any injuries per protocol.Case data was also requested.In a follow up call 1 hour later, the nurse reported that the patient was terminal with very poor circulatory status.The patients blood pressure was 57/30 and heart rate was 20bpm.The patient expired at approximately 1pm on (b)(6) 2017 due to natural causes.The nurse reported that the death was due to the patient's condition, and did not allege the death against the device.It was later reported that the patient was on vasopressors.Therapy was discontinued after a large skin tear on the right thigh and skin tears on the torso were found.There was blistering on the back and red skin on the edges of the pads.The facility stated that there protocol was to perform skin checks every 4 hours.The nurse stated that there was no treatment of the skin, due to the patient's condition.The patient died hours after treatment was stopped due to natural causes.The cause of death was reported as cardiogenic shock.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.

• Brand Name: ARCTIC GEL PADS
• Type of Device: ARCTIC 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: amy gravley ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 6312718
• MDR Text Key: 66859214
• Report Number: 1018233-2017-00373
• Device Sequence Number: 1
• Product Code: DWJ
• 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: health professional,other
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 317-09
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2017
• 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 Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR
• Patient Weight: 122