MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, TEMPERATURE CABLE

Device Problems Failure to Sense (1559); Device Sensing Problem (2917)

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

Event Date 01/26/2022

Event Type  malfunction  

Event Description

It was reported that the nurse was attempting to initiate hypothermia on the arctic sun device and the temperature probe was not reading.Bladder probe was in place.The device dashes where patient temperature displayed.Nurse made sure the temperature cable was in temperature port 1.Mss explained that this could be from issue with the temperature in cable or the bladder probe.Mss recommended the nurse to change out the temperature in cable first and then the bladder probe if needed.Nurse stated that the bladder probe did read on their overhead screen.Mss also explained how the temperature in cable was removed and would obtain another cable.Per follow up information received via ibc on (b)(6) 2022, nurse stated that they replaced the temperature cable as suggested by mss and was able to complete therapy with no further issues.Nurse also stated there was no impact to patient and old temperature cable was taken by biomed.

Manufacturer Narrative

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

Manufacturer Narrative

The reported issue was confirmed.The root cause of the reported issue was damaged temperature cable.Bladder probe was in place.The device dashes where patient temperature displayed.Nurse made sure the temperature cable was in temperature port 1.Mss explained that this could be from an issue with the temperature in cable or the bladder probe.Mss recommended the nurse to change out the temperature in cable first and then the bladder probe if needed.Nurse stated that the bladder probe did read on their overhead screen.Mss also explained how the temperature in cable was removed and would obtain another cable.Per follow up information received via ibc on 31jan2022, nurse stated that they replaced the temperature cable as suggested by mss and was able to complete therapy with no further issues.Nurse also stated there was no impact to patient and old temperature cable was taken by biomed.The device was in use on a patient.The lot number was unknown; therefore, the device history record could not be reviewed.Unable to perform labeling review due to unknown product code.Although the product family was unknown, the (temperature cable) product ifus were found to be adequate based on past reviews.Correction: g,f,h 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 device was not returned.

Event Description

It was reported that the nurse was attempting to initiate hypothermia on the arctic sun device and the temperature probe was not reading.Bladder probe was in place.The device dashes where patient temperature displayed.Nurse made sure the temperature cable was in temperature port 1.Mss explained that this could be from issue with the temperature in cable or the bladder probe.Mss recommended the nurse to change out the temperature in cable first and then the bladder probe if needed.Nurse stated that the bladder probe did read on their overhead screen.Mss also explained how the temperature in cable was removed and would obtain another cable.Per follow up information received via ibc on (b)(6)2022, nurse stated that they replaced the temperature cable as suggested by mss and was able to complete therapy with no further issues.Nurse also stated there was no impact to patient and old temperature cable was taken by biomed.

• Brand Name: ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, TEMPERATURE CABLE
• Type of Device: TEMPERATURE CABLE
• 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: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 13553253
• MDR Text Key: 285952772
• Report Number: 1018233-2022-00701
• Device Sequence Number: 1
• Product Code: DWJ
• 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: 06/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/17/2022
• 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