MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN 5000; ARCTIC SUN DEVICE

Model Number 50000000

Device Problems Insufficient Cooling (1130); Output Problem (3005)

Patient Problems Death (1802); Brain Injury (2219); Respiratory Failure (2484); Patient Problem/Medical Problem (2688)

Event Date 08/22/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event Description

It was reported that an arctic sun device alerted 52 (extended period of cold water) and alarmed 53 (prolonged cold water exposure) on (b)(6) 2019.Arctic sun therapy was initiated on (b)(6) 2019, due to the patient developing a neurogenic fever.Ms&s was called for assistance in troubleshooting the alert 52 and alarm 53.The target temperature was adjusted, which caused the alert and alarm to stop, but reoccurred in the morning on (b)(6) 2019.Ms&s reminded the nurse about the importance of skin checks.The nurse stated that the patient was not shivering and did not have any infections.The patient also had a bair hugger in place.Ms&s advised the nurse to discuss the heat generation with the doctor.Follow up calls were placed to the facility and it was confirmed by another nurse that the patients¿ temperature remained around 37.8c during most of the therapy.The target temperature was not able to be obtained.The (b)(6), female patient expired during the night shift on (b)(6) 2019 after the decision was made to withdraw care.The nurse stated that cause of death was due to the patients¿ condition and was not device related.The cause of death was acute respiratory failure due to an anoxic brain injury.The patient had been admitted on (b)(6) 2019 for thermoregulation.She had a history of cerebral edema, cerebral stroke, and calcified intracranial adhesions.The patient was receiving buspar, bromocriptine, and tylenol.

Manufacturer Narrative

The device was not returned for evaluation.The serial number for the device associated with this particular event could not be identified by the complainant; however, the following serial numbers (serial number (b)(4) :date of manufacture: 2016-10-07; serial number (b)(4) :date of manufacture: 2016-10-07; serial # (b)(4) :date of manufacture: 2018-08-29; serial # (b)(4) :date of manufacture: 2018-08-29; serial # (b)(4) : date of manufacture: 2018-08-29; serial # (b)(4) :date of manufacture: 2018-08-21; serial # (b)(4) :date of manufacture: 2018-08-21 ) that were in use at the time this event occurred underwent a manufacturing review and the device history records found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: ¿hypothermia settings use the hypothermia settings screen to view the current settings and modify the settings for the following parameters.To modify any parameter setting, press the adjust button to the right of the parameter.Hypothermia settings screen parameters: therapy settings ¿ cooling begins ¿ rewarming begins water temperature settings ¿ pre-condition water ¿ manual control ¿ high water limit ¿ low water limit patient temperature settings ¿ high patient alert ¿ low patient alert ¿ control strategy display settings ¿ temperature units ¿ temperature units adjust ¿ patient temp 2 to access the hypothermia settings screen: 1) press adjust on the cool patient window or the rewarm patient window.2) press the more button on the cool patient adjust window or rewarm patient adjust window.3) the hypothermia settings screen will be displayed.4) to save the new settings as the current patient therapy settings, press the close button.For instructions on saving the settings as the system defaults, see advanced setup." h11:section a through f - the information provided by bd 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 bd.H3 other text : the device was not returned.

Event Description

It was reported that an arctic sun device alerted 52 (extended period of cold water) and alarmed 53 (prolonged cold water exposure) on (b)(6)2019.Arctic sun therapy was initiated on (b)(6)2019 , due to the patient developing a neurogenic fever.Ms&s was called for assistance in troubleshooting the alert 52 and alarm 53.The target temperature was adjusted, which caused the alert and alarm to stop, but reoccurred in the morning on(b)(6)2019.Ms&s reminded the nurse about the importance of skin checks.The nurse stated that the patient was not shivering and did not have any infections.The patient also had a bair hugger in place.Ms&s advised the nurse to discuss the heat generation with the doctor.Follow up calls were placed to the facility and it was confirmed by another nurse that the patients¿ temperature remained around 37.8c during most of the therapy.The target temperature was not able to be obtained.The 24-year old, female patient expired during the night shift on (b)(6)2019 after the decision was made to withdraw care.The nurse stated that cause of death was due to the patients¿ condition and was not device related.The cause of death was acute respiratory failure due to an anoxic brain injury.The patient had been admitted on 19 aug 2019 for thermoregulation.She had a history of cerebral edema, cerebral stroke, and calcified intracranial adhesions.The patient was receiving buspar, bromocriptine, and tylenol.

• Brand Name: ARCTIC SUN 5000
• Type of Device: ARCTIC SUN DEVICE
• Manufacturer (Section D): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; louisville CO 80027
• MDR Report Key: 8982711
• MDR Text Key: 206991476
• Report Number: 1018233-2019-05491
• Device Sequence Number: 1
• Product Code: DWJ
• UDI-Device Identifier: 00801741080142
• UDI-Public: (01)00801741080142
• Combination Product (y/n): N
• PMA/PMN Number: K161602
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 10/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 50000000
• Device Catalogue Number: 50000000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 24 YR