MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTICGEL PADS; ARCTIC SUN PADS

Catalog Number UNKNOWN

Device Problem Device Displays Incorrect Message (2591)

Patient Problems Cardiac Arrest (1762); Death (1802); Hypothermia (1915); Skin Discoloration (2074); Loss of consciousness (2418); Partial thickness (Second Degree) Burn (2694)

Event Date 12/03/2017

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 an alarm 115 (prolonged water exposure) sounded at 11:00 pm on (b)(6) 2017 during therapy on arctic sun device, sn (b)(4).The ms&s helpline was called on (b)(6) 2017 at 10:07 am.The facility stated that patient¿s skin was mottled when the alarm sounded, but therapy had been continued.The next time a skin check was done, both legs were blistered and the skin under the chest pads was not blanching and was blistered.Ms&s advised to remove the pads and save them.The pads were removed from the patient on (b)(6) 2017 approximately between 10:00 and noon.During a follow up call it was stated that the patient came to the hospital in full cardiac arrest and was unresponsive for about an hour.The patient was hypothermic and in the rewarming phase of therapy.However, the patient would not warm.It was further stated that there was not any treatment done to the blisters because the family withdrew all care.The patient expired on (b)(6) 2017 at 3:40 pm.The nurse stated that cause of death was related to the post cardiac arrest.The patient had been maxed out on vasopressors.

Manufacturer Narrative

Upon further review, bard medical has determined that this mdr was initially reported in error as this event is not reportable.

Event Description

It was reported an alarm 115 (prolonged water exposure) sounded at 11:00 pm on (b)(6) 2017 during therapy on arctic sun device, (b)(4).The ms&s helpline was called on (b)(6) 2017 at 10:07 am.The facility stated that patient¿s skin was mottled when the alarm sounded, but therapy had been continued.The next time a skin check was done, both legs were blistered and the skin under the chest pads was not blanching and was blistered.Ms&s advised to remove the pads and save them.The pads were removed from the patient on (b)(6) 2017 approximately between 10:00 and noon.During a follow up call it was stated that the patient came to the hospital in full cardiac arrest and was unresponsive for about an hour.The patient was hypothermic and in the rewarming phase of therapy.However, the patient would not warm.It was further stated that there was not any treatment done to the blisters because the family withdrew all care.The patient expired on (b)(6) 2017 at 3:40 pm.The nurse stated that cause of death was related to the post cardiac arrest.The patient had been maxed out on vasopressors.

• Brand Name: ARCTICGEL PADS
• Type of Device: ARCTIC SUN PADS
• Manufacturer (Section D): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; louisville CO 80027
• MDR Report Key: 7147902
• MDR Text Key: 95831188
• Report Number: 1018233-2017-06493
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• PMA/PMN Number: K142702
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 03/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention