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

Model Number 50000000E

Device Problem Insufficient Cooling (1130)

Patient Problems Convulsion/Seizure (4406); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/13/2021

Event Type  malfunction  

Event Description

It was reported that the patient was cooling to a target temperature of 33c on the arctic sun device.Therapy began around 1 pm and the device was getting an alert 113 (reduced water temperature control).Patient temperature was 35.8c, flow rate was 2.8lpm, water temperature was 7.2c, chiller temperature (t4) was 3.7c, mixing pump command was 100 percent, pump hours were 2130 and system hours were 2379.Mss suggested closing out the alert and monitoring the patient and water temperatures.The device was attempting to make water temperature at 4c, but the water temperature was only 7c.The patient was not shivering but might be seizing.There were some twitching motions and patient was biting down on their tube.Mss advised to address heat generation per facility protocol.They had a bair hugger on and recently decreased the temperature on it.2 hours later, patient temperature was down to 33.9c, the water temperature was increasing, and they were no longer getting alert 113 (reduced water temperature control).

Manufacturer Narrative

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

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 the patient was cooling to a target temperature of 33c on the arctic sun device.Therapy began around 1 pm and the device was getting an alert 113 (reduced water temperature control).Patient temperature was 35.8c, flow rate was 2.8lpm, water temperature was 7.2c, chiller temperature (t4) was 3.7c, mixing pump command was 100 percent, pump hours were 2130 and system hours were 2379.Mss suggested closing out the alert and monitoring the patient and water temperatures.The device was attempting to make water temperature at 4c, but the water temperature was only 7c.The patient was not shivering but might be seizing.There were some twitching motions and patient was biting down on their tube.Mss advised to address heat generation per facility protocol.They had a bair hugger on and recently decreased the temperature on it.2 hours later, patient temperature was down to 33.9c, the water temperature was increasing, and they were no longer getting alert 113 (reduced water temperature control).

Event Description

It was reported that the patient was cooling to a target temperature of 33c on the arctic sun device.Therapy began around 1 pm and the device was getting an alert 113 (reduced water temperature control).Patient temperature was 35.8c, flow rate was 2.8lpm, water temperature was 7.2c, chiller temperature (t4) was 3.7c, mixing pump command was 100 percent, pump hours were 2130 and system hours were 2379.Mss suggested closing out the alert and monitoring the patient and water temperatures.The device was attempting to make water temperature at 4c, but the water temperature was only 7c.The patient was not shivering but might be seizing.There were some twitching motions and patient was biting down on their tube.Mss advised to address heat generation per facility protocol.They had a bair hugger on and recently decreased the temperature on it.2 hours later, patient temperature was down to 33.9c, the water temperature was increasing, and they were no longer getting alert 113 (reduced water temperature control).Per follow up information received on 04jan2022, the patient was able to complete therapy on same device with the help of mss.There was no patient injury and customer did not have the current status of the device.

Manufacturer Narrative

Per additional information received, bd has determined that this mdr event is not reportable.H11: section a through f - 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.H3 other text : the device was not returned.

• 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: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 13094381
• MDR Text Key: 285408668
• Report Number: 1018233-2021-08464
• Device Sequence Number: 1
• Product Code: DWJ
• UDI-Device Identifier: 00801741127755
• UDI-Public: (01)00801741127755
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 01/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 50000000E
• Device Catalogue Number: 50000000E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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