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

Catalog Number UNKNOWN

Device Problems Insufficient Cooling (1130); Insufficient Information (3190)

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

Event Date 01/27/2021

Event Type  malfunction  

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 the patient was above target while undergoing therapy on arctic sun device.The patient temperature was 37.8c, the target temperature was 35c, the water temperature was 31.1c, and the flow rate was 2.6lpm.They confirmed an alert 113 (reduced water temperature) in the event log.System hours were 7030, the pump hours were 6497, the chiller temperature (t4) was 4.3c and the mixing pump command was 100%.Ms&s advised to stop therapy, empty pads and send device to biomed labeled mixing pump.Per follow up via nurse on 27jan2021, switched to a second device to continue therapy.Therapy was discontinued on second device.2nd device was kept in service and 1st device was sent to biomed.

Event Description

It was reported that the patient was above target while undergoing therapy on arctic sun device.The patient temperature was 37.8c, the target temperature was 35c, the water temperature was 31.1c, and the flow rate was 2.6lpm.They confirmed an alert 113 (reduced water temperature) in the event log.System hours were 7030, the pump hours were 6497, the chiller temperature (t4) was 4.3c and the mixing pump command was 100%.Ms&s advised to stop therapy, empty pads and send device to biomed labeled mixing pump.Per follow up via nurse on 27jan2021, switched to a second device to continue therapy.Therapy was discontinued on second device.2nd device was kept in service and 1st device was sent to biomed.

Manufacturer Narrative

The reported issue was inconclusive.The root cause of the reported issue could not be determined.A potential root cause of the reported issue could be the outlet water temperature regulation error.However, this cannot be confirmed.Switched to a second device to continue therapy.Therapy was discontinued on second device.2nd device was kept in service.All good faith attempts have been made to obtain additional information.The outcome of the repair cannot be determined at this time.In the event that information regarding the outcome of the repair and the status of the device is received, this record will be reopened to update the investigation.It is unknown if the device met specifications and whether the device was influenced by the reported failure.The device was in use on a patient.The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.Although the product family is unknown, the arctic sun ifus are found to be adequate based on past reviews.The device was not returned.

• Brand Name: UNKNOWN ARCTICSUN 5000
• Type of Device: UNKNOWN ARCTIC SUN DEVICE
• Manufacturer (Section D): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; suite 200; louisville 80027
• MDR Report Key: 11345509
• MDR Text Key: 233078722
• Report Number: 1018233-2021-00651
• 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: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 08/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other