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

Catalog Number 317-09

Device Problems Loss of Power (1475); Self-Activation or Keying (1557)

Patient Problems Death (1802); Respiratory Failure (2484); Partial thickness (Second Degree) Burn (2694)

Event Date 10/01/2016

Event Type  Injury  

Manufacturer Narrative

The device was not returned for evaluation; however, a photo of the patient was received.During the visual evaluation of the photo it was not possible to describe any condition of the product that would have contributed to the reported issue since the photo is about the patient.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use states 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.¿ (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 on (b)(6), small blisters were found on the skin around the outline of the pad when the pad was removed.The water temperature was consistently high (42 degrees c) for a long duration of time (10 hours).The alarms were noted and the device turned itself off.It was stated that the staff admitted that they were not diligent with skin checks because the patient was very sick with numerous other therapies going and the staff was very busy.The patient was on dialysis during the arctic sun treatment.It was also reported that the patient could not be rolled due to his/her condition.It has been reported that the patient passed away on (b)(6).The cause of death was respiratory failure.The patient was on vasopressors.The arctic sun therapy was started with a target temperature of 35, and the patient was managed well.After 24 hours, dialysis was started and the target temperature was increased to 37.The patient's blood was not being warmed on return to the body.The water temp was over 38 degrees for 8 hours and flow rate was on average at 1.9.The patient was unstable and could not be turned without his stats dropping acutely.The patient had 2 days of arctic sun therapy.It was stated by the facility that the patient was a large man and probably could have used an extra pad.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 SUN 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: janna parks ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 6045638
• MDR Text Key: 58018721
• Report Number: 1018233-2016-01448
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K142702
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 317-09
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/05/2016
• Initial Date FDA Received: 10/20/2016
• 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