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

Catalog Number UNKNOWN

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Death (1802); Rash (2033); Therapeutic Effects, Unexpected (2099)

Event Date 03/31/2016

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. Sample was discarded.

Event Description

It was reported that the biomed department called the medical helpline wanting to do a functional check on the device. The biomed technician stated that a normothermia patient with a target temperature of 37c developed blisters under the pads. The patient temperature was 35c. Nurse wants the machine checked to make sure no one changed the settings during therapy. The patient had been intubated for 20 days and was on continuous renal replacement. The patient was placed on the arctic sun on the weekend of ((b)(6) 2016) on normothermia. The patient was set to be rewarmed to 37c, but only achieved 35. 6c. The patient was taken off the device on sunday morning ((b)(6) 2016). During the evening, the doctor decided to place the patient back on the machine. The blisters were discovered later in the week. A wound consult was done and the wound nurse placed silverdene on the blisters. The doctor was consulted about the blisters, and he stated that they were superficial. The clinical educator stated that the nurses were not performing proper skin checks on the patient. The patient was septic and had unstable blood pressure. The patient expired on friday, ((b)(6) 2016) due to her comorbidities. 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 death.

Manufacturer Narrative

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 state the following: "do not place arcticgel pads on skin that has signs ofulcerations, 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.

• Brand Name: ARCTICGEL 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: 5604525
• MDR Text Key: 43515074
• Report Number: 1018233-2016-00503
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K002577
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 04/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/25/2016
• 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 Treatment Data

Date Received: 04/25/2016 Patient Sequence Number: 1