MAUDE Adverse Event Report: ARCTIC SUN® 5000; ARCTIC SUN DEVICE

Model Number 50000000E

Device Problem Insufficient Cooling (1130)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/02/2021

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 the arctic sun device had no alarm.The nurse was concerned about the patient temperature was not stable and started on normothermia.The patient target temperature was set to 37 c, and the patient temperature started to increase.The nurse stated they noticed shivering and started shiver protocol along with the bair hugger.The nurse decided to place the device in hypothermia mode.At the same time, the nurse noticed water level was low and filled the machine.The target temperature was set to 37 c.The patient temperature was 38.1 c.The water temperature was 10 c at beginning of call, by end of call the water temperature decreased to 9.4 c.The water temperature was set at 4 c.The foley probe was in place, second temperature source was correlating.The device was noted to be doing what it should be doing.The nurse would look into tylenol.Per follow up 1 on 04feb2021 via nurse, the patient continuing the therapy at a controlled rewarm.The medications were given as per the facility's shiver protocol for when the patient needs the control of movements on the device.The nurse did not have the medication list available.

Manufacturer Narrative

The reported issue was unconfirmed.The root cause of the reported issue was unable to be determined, as the device met specifications during evaluation.Nurse was concerned patient temp was not stable.They started on normothermia.Patient target was set to 37c.Patient temp started to increase.Nurse stated they noticed shivering and started shiver protocol along with placing bair hugger.Nurse decided to place in hypothermia mode before she called.At the same time, she noticed water level was low.Nurse filled the machine.Target was set to 37c.Patient temp was 38.1c.Water temp was 10c at beginning of call, by end of call water temp decreased to 9.4c.Water was set at 4c.Foley was in place, second temp source was correlating.At this time machine was noted to be doing what it should be doing.Nurse stated she would look into tylenol.Issue was unrelated to the machine.No repairs were made as the device was scrapped: control panel, i/o card, isolation card, processor card, power card, circulation pump, mixing pump motor, chiller pump, chiller, ac cca main voltage card, and power supply.It is unknown if the device was influenced by the reported failure, however the device met specifications during evaluation.The device was in use on a patient.Bmd investigation indicates that the reported issue was unconfirmed and risk review not required.Bmd investigation indicates that the reported issue was unconfirmed and labeling review not required.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 actual/suspected device was inspected.

Event Description

It was reported that the arctic sun device had no alarm.The nurse was concerned about the patient temperature was not stable and started on normothermia.The patient target temperature was set to 37 c, and the patient temperature started to increase.The nurse stated they noticed shivering and started shiver protocol along with the bair hugger.The nurse decided to place the device in hypothermia mode.At the same time, the nurse noticed water level was low and filled the machine.The target temperature was set to 37 c.The patient temperature was 38.1 c.The water temperature was 10 c at beginning of call, by end of call the water temperature decreased to 9.4 c.The water temperature was set at 4 c.The foley probe was in place, second temperature source was correlating.The device was noted to be doing what it should be doing.The nurse would look into tylenol.Per follow up 1 on 04feb2021 via nurse, the patient continuing the therapy at a controlled rewarm.The medications were given as per the facility's shiver protocol for when the patient need the control of movements on the device.The nurse did not have the medication list available.

• Brand Name: ARCTIC SUN® 5000
• Type of Device: ARCTIC SUN DEVICE
• MDR Report Key: 11378738
• MDR Text Key: 234788693
• Report Number: 1018233-2021-00807
• Device Sequence Number: 1
• Product Code: DWJ
• UDI-Device Identifier: 00801741127755
• UDI-Public: (01)00801741127755
• 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: 10/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2021
• Initial Date Manufacturer Received: 02/02/2021
• Initial Date FDA Received: 02/25/2021
• Supplement Dates Manufacturer Received: 10/22/2021
• Supplement Dates FDA Received: 11/01/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2019
• 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