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

Catalog Number 50000000

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/08/2023

Event Type  malfunction  

Event Description

It was reported that the arctic sun device had low flow, alert 41(low internal flow).It came for preventive maintenance service.Per sample evaluation results on (b)(6) 2023, it was reported that the transducer o-ring was found torn.

Manufacturer Narrative

The reported issue was confirmed.The root cause of the reported issue could not be determined.A potential root cause of the reported issue could be repeated force exposure.However, this cannot be confirmed.The device was evaluated upon receipt.Transducer o-ring was found torn.Picture sample confirmed reported issue.Transducer o-ring was also replaced.The device passed all the testing and is now ready for used.A dhr is not required as the reported event is not an out of box failure and therefore the reported event is not manufacturing related.The instructions for use were found adequate and state the following: "indications for use the arctic sun¿ temperature management system is a thermal regulating system, indicated for monitoring and controlling patient temperature in adult and pediatric patients of all ages.Warnings and cautions.Warnings.Do not use the arctic sun¿ temperature management system in the presence of flammable agents because an explosion and/or fire may result.Do not use high frequency surgical instruments or endocardial catheters while the arctic sun¿ temperature management system is in use.There is a risk of electrical shock and hazardous moving parts.There are no user serviceable parts inside.Do not remove covers.Refer servicing to qualified personnel.Power cord has a hospital grade plug.Grounding reliability can only be achieved when connected to an equivalent receptacle marked ¿hospital use¿ or ¿hospital grade¿.When using the arctic sun¿ temperature management system, note that all other thermal conductive systems, such as water blankets and water gels, in use while warming or cooling with the arctic sun¿ temperature management system may actually alter or interfere with patient temperature control.Do not place arcticgel¿ pads over transdermal medication patches as warming can increase drug delivery, resulting in possible harm to the patient.The arctic sun¿ temperature management system is not intended for use in the operating room environment.Medivance supplies temperature simulators (fixed value resistors) for testing, training and demonstration purposes.Never use this device, or other method, to circumvent the normal patient temperature feedback control when the system is connected to the patient.Doing so exposes the patient to the hazards associated with severe hypo- or hyper-thermia.Cautions this product is to be used by or under the supervision of trained, qualified medical personnel.Federal law (usa) restricts this device to sale, by or on the order of a physician.Use only sterile water.The use of other fluids will damage the arctic sun¿ temperature management system.When moving the arctic sun¿ temperature management system always use the handle to lift the controller over an obstacle to avoid over balancing.The patient¿s bed surface should be located between 30 and 60 inches (75 cm and 150 cm) above the floor to ensure proper flow and minimize risk of leaks.The clinician is responsible to determine the appropriateness of custom parameters.When the system is powered off, all changes to parameters will revert to the default unless the new settings have been saved as new defaults in the advanced setup screen.For small patients (=30 kg) it is recommended to use the following settings: water temperature high limit =40°c (104°f); water temperature low limit =10°c (50°f); control strategy = 2.It is recommended to use the patient temperature high and patient temperature low alert settings.Manual control is not recommended for patient temperature management.The operator is advised to use the automatic therapy modes (e.G.Control, patient, cooling, rewarming) for automatic patient temperature monitoring and control.The arctic sun¿ temperature management system will monitor and control patient core temperature based on the temperature probe attached to the system.The clinician is responsible for correctly placing the temperature probe and verifying the accuracy and placement of the patient probe at the start of the procedure.Medivance recommends measuring patient temperature from a second site to verify patient temperature.Medivance recommends the use of a second patient temperature probe connected to the arctic sun¿ temperature management system temperature 2 input as it provides continuous monitoring and safety alarm features.Alternatively, patient temperature may be verified periodically with independent instrumentation.The displayed temperature graph is for general information purposes only and is not intended to replace standard medical record documentation for use in therapy decisions." h11: section a through f - the information provided by bd represents all 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 actual/suspected device was inspected.

• Brand Name: ARCTIC SUN® 5000
• Type of Device: ARCTIC SUN DEVICE
• Manufacturer (Section D): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; suite 200; louisville 80027
• Manufacturer (Section G): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; suite 200; louisville 80027
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 18452293
• MDR Text Key: 332732000
• Report Number: 1018233-2024-00008
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K161602
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 50000000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other