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

Catalog Number 50000000E

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Myocardial Infarction (1969); Respiratory Distress (2045); Seizures (2063); Sepsis (2067); Skin Discoloration (2074); Skin Irritation (2076); Diabetic Ketoacidosis (2364); Meningitis (2389); Burn, Thermal (2530)

Event Date 01/30/2019

Event Type  Injury  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.

Event Description

It was reported that a patient allegedly experienced frostbite to his bilateral lower extremities during arctic sun therapy.A physician placed a call to the ms&s helpline on (b)(6) 2019 at 2:23 pm to report that he had a patient with peripheral vascular disease on normothermia who developed frostbite.He also stated that the patient was no longer on the device during the time of the call.On (b)(6) 2019, it was reported via email from (b)(6), stating that the patient expired unrelated to the device.The patient was placed on the arctic sun device on (b)(6) 2019 due to hyperthermia.Skin assessments were performed every four hours on the patient.On (b)(6) 2019, blisters and a mottled appearance were noted on the patient¿s thighs bilaterally and on the right knee, and mepilex dressings were applied to the affected areas.The patient weighed (b)(6) and a set of large pads were in use.The water temperature ranged from 4.7c to 41.9c during therapy.The cause of death is unknown at this time; however, the facility stated that the patient expired unrelated to the device.The patient was found unresponsive and admitted to the hospital with seizures, myocardial infarction, bacterial meningitis, sepsis, respiratory failure, positive posturing, rhabdomyolysis, and diabetic ketoacidosis.The device was evaluated and passed the functional check and then returned to service.

Event Description

It was reported that a patient allegedly experienced frostbite to his bilateral lower extremities during arctic sun therapy.A physician placed a call to the ms&s helpline on (b)(6)2019 at 2:23 pm to report that he had a patient with peripheral vascular disease on normothermia who developed frostbite.He also stated that the patient was no longer on the device during the time of the call.On (b)(6)2019, it was reported via email from gayle montoya, bd sr.Clinical manager, stating that the patient expired unrelated to the device.The patient was placed on the arctic sun device on (b)(6)2019 due to hyperthermia.Skin assessments were performed every four hours on the patient.On(b)(6)2019 , blisters and a mottled appearance were noted on the patient¿s thighs bilaterally and on the right knee, and mepilex dressings were applied to the affected areas.The patient weighed 122.5 kg and a set of large pads were in use.The water temperature ranged from 4.7c to 41.9c during therapy.The cause of death is unknown at this time; however, the facility stated that the patient expired unrelated to the device.The patient was found unresponsive and admitted to the hospital with seizures, myocardial infarction, bacterial meningitis, sepsis, respiratory failure, positive posturing, rhabdomyolysis, and diabetic ketoacidosis.The device was evaluated and passed the functional check and then returned to service.

Manufacturer Narrative

The reported event was inconclusive based on the case photos.There was no evidence to link the reaction to the pads.The photos showed redness and minor frostbite to the bilateral lower extremities.However, no physical sample of the product was returned for evaluation, therefore the root cause could not be determined.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: ¿directions for use 1.Arcticgel¿ pads are only for use with an arctic sun® temperature management system control module.See operators manual for detailed instructions on system use.2.Select the proper number, size and style pad for the patient size and clinical indication.However, the rate of temperature change and potentially the final achievable temperature is affected by pad surface area, patient size, pad placement and water temperature range.Best system performance will be achieved by using the maximum number and largest size pads.3.For patient comfort, the pads may be prewarmed using water temperature control mode (manual) prior to application.4.Place the pads on healthy, clean skin only.Remove any creams or lotions from patient¿s skin before pad application.Remove the release liner from each pad and apply to the appropriate area.The pads may be overlapped or folded adhesive-to-adhesive to achieve proper placement.The pads may be removed and reapplied if necessary.The pad surface must be contacting the skin for optimal energy transfer efficiency.Place pads to allow for full respiratory excursion.5.Attach the pad¿s line connectors to the patient line manifolds.Begin circulating water through the pads using either patient temperature control mode (automatic) or water temperature control mode (manual).If the pads fail to prime or a significant continuous air leak is observed in the pad return line, check connections, then if needed replace the leaking pad.6.Once the pads are primed, assure the flow rate displayed on the control panel is greater than 2.3 liters per minute, which is the minimum flow rate for a full pad kit.7.When finished, empty water from pads.Cold temperature increases the adhesiveness of the hydrogel.For ease of removal, leave pads on the patient for approximately 15 minutes to allow the hydrogel to warm.Slowly remove pads from the patient and discard." correction:mfr site, concomitant medical products and device evaluated by mfr.

• Brand Name: ARCTIC SUN 5000
• Type of Device: ARCTIC GEL PADS
• Manufacturer (Section D): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; louisville CO 80027
• MDR Report Key: 8355217
• MDR Text Key: 136732622
• Report Number: 1018233-2019-00896
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• PMA/PMN Number: K161602
• 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: 06/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 50000000E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2019
• Date Manufacturer Received: 05/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 40 YR
• Patient Weight: 122