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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Edema (1820); Erythema (1840); Swelling (2091); Tissue Damage (2104); Multiple Organ Failure (3261)

Event Date 12/19/2016

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.The device was not returned.

Event Description

It was reported that upon removal of the arctic sun gel pads on an expired patient, deep red/purple tissue injury was found on the torso and legs of the patient.The nurse was unable to remove the pads during therapy due to the fragility of the skin consistent with edema and blisters.The patient allegedly experienced multiple organ failure.The family made the decision to decelerate care.Clinical statement: the patient was in multiple organ failure.The family had decided to decelerate care of the patient.The facility stated that all medical equipment had been removed from the patient except the arctic sun.There is no indication, report, or allegation that the device malfunction was related to the patient's death.

Manufacturer Narrative

The reported event was inconclusive because no sample was returned for evaluation.Case data was received and according to the evaluation of the case data, it will not be able to help confirm or un-confirm the reported issue of tissue injury because this only gives the arctic sun readings.However, the device was heating and cooling properly during therapy.The device called for 40c water a lot during therapy because the patient temperature was dropping.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.The device was not returned.

Event Description

It was reported that upon removal of the arctic sun gel pads on an expired patient, deep red/purple tissue injury was found on the torso and legs of the patient.The nurse was unable to remove the pads during therapy due to the fragility of the skin consistent with edema and blisters.The patient allegedly experienced multiple organ failure.The family made the decision to decelerate care.Clinical statement: the patient was in multiple organ failure.The family had decided to decelerate care of the patient.The facility stated that all medical equipment had been removed from the patient except the arctic sun.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: 6448596
• MDR Text Key: 71332267
• Report Number: 1018233-2017-01457
• 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: other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/07/2017
• 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