Arctic Sun® Temperature Management System, Temperature Cable Bard 73503Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741080302), received between Dec 10, 2018 and Oct 20, 2023 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Device Sensing Problem” (4 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 20, 2023Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT ALERT 14 (PATIENT TEMPERATURE 1 PROBE OUT OF RANGE) OCCURRED ON ARCTIC SUN TEMPERATURE PROBE CABLE DURING PATIENT USE. IT WAS STATED THAT THE UPON CONFIRMATION, THE TEMPERATURE PROBE WAS FOUND TO BE MALFUNCTIONING. PER ADDITIONAL INFORMATION VIA EMAIL FROM IBC ON 10OCT2023, THE ISSUE WAS RESOLVED BY USING A NEW DEVICE. IT WAS CONFIRMED THAT THERE WAS NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17975699 ↗
• MalfunctionJun 8, 2023Erratic or Intermittent Display; Device Sensing Problem; Erratic or Intermittent Display; Device Sensing Problem

  IT WAS REPORTED THAT THE PROBE WAS NOT REGISTERING. THE NURSE HAD TO CHANGE OUT THE PATIENT PROBE, BUT THE DEVICE WAS WORKING FINE NOW. THE REPRESENTATIVE CONFIRMED THAT THEY CHANGED THE PROBE AND NOT THE TEMPERATURE IN CABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17086151 ↗
• MalfunctionFeb 15, 2023No Display/Image; No Display/Image

  IT WAS REPORTED THAT AN EMERGENCY RESPONSE WAS REQUESTED BECAUSE THE PATIENT BODY TEMPERATURE WAS NOT DISPLAYED WHILE USING THE TEMPERATURE CABLE OF THE ARCTIC SUN DEVICE IN THE INTENSIVE CARE UNIT. THEY SHOULD BRING A REPLACEMENT FOR THE TEMPERATURE PROBE CONNECTION CABLE AND CHECK THAT THE BODY TEMPERATURE WAS DISPLAYED NORMALLY. THEY EXPLAINED THE TEACHER THAT THE CABLE WAS BROKEN. PER FOLLOW-UP INFORMATION, RECEIVED VIA ON 09-FEB-2023, THEY SHOULD BRING A REPLACEMENT FOR THE TEMPERATURE PROBE CONNECTION CABLE AND CHECK THAT THE BODY TEMPERATURE WAS DISPLAYED NORMALLY. NO PATIENT INFORMATION PROVIDED FROM CUSTOMER. THE THERAPY WAS COMPLETED WITH ANOTHER DEVICE. DUE TO THE BROKEN OF TEMPERATURE CABLE ONLY THE TEMPERATURE WAS NOT DISPLAYED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16378338 ↗
• MalfunctionFeb 3, 2023Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT WHEN THE CABLE WAS CONNECTED TO THE ARCTIC SUN 5000 AND TRIED TO USE ON THE PATIENT, THE PATIENT TEMPERATURE WAS NOT DISPLAYED. WHEN REPLACED THE BLADDER TEMPERATURE SENSOR AND THE CABLE WITH ANOTHER ONE, IT WAS CONFIRMED THAT THERE WAS A PROBLEM WITH THE PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16295042 ↗
• MalfunctionMay 19, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THE TEMPERATURE CABLE APPEARED TO BE BROKEN ON THE ARCTIC SUN DEVICE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 14435090 ↗
• MalfunctionDec 10, 2018Device Sensing Problem; Device Sensing Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT WHILE RECEIVING THERAPY ON AN ARCTIC SUN DEVICE THERE WAS AN ALERT REGARDING TEMP 1. WHEN CONNECTED TO A CRITICORE DEVICE, THE FOLEY TEMPERATURE READ APPROPRIATELY. PER TROUBLESHOOTING WITH MS&S, THE NURSE CONFIRMED THE CABLE WAS PLACED IN THE TEMP 1 OUTLET. THE NURSE ALSO STATED THAT SINCE THERE WAS NOT A SPARE CABLE AVAILABLE, THEY WOULD NEED TO SWITCH OUT THE ARCTIC SUN DEVICE. A FOLLOW-UP CALL BY THE FIELD ASSURANCE CLINICAL RISK TEAM WAS PLACED ON MONDAY, 26-NOV-2018. ICU NURSE SEAN DODGE STATED THAT THE PATIENT WAS A 68 YEAR OLD MALE WITH A WEIGHT OF 74 KG AND NO PREVIOUS MEDICAL HISTORY. THE PATIENT PRESENTED TO THE EMERGENCY ROOM ON MONDAY, 19-NOV-2018 WHERE HE CODED FOUR TIMES FROM CARDIAC ARREST. THE PATIENT WAS SENT TO THE CATH LAB BEFORE ARRIVING IN ICU AND WAS PLACED ON THE ARCTIC SUN DEVICE ON 20-NOV-2018 AT APPROXIMATELY 2:00 AM. NEAR THE SAME TIME OF THE ALERT REGARDING TEMP 1, THE PATIENT¿S CONDITION DETERIORATED AND HE CODED AGAIN FOR A 5TH TIME. DUE TO THE PATIENT¿S CONDITION, CARE WAS WITHDRAWN AT THE FAMILY¿S REQUEST. THE PATIENT WAS PRONOUNCED DEAD AT 3:48AM ON 20-NOV-2018. PER ICU NURSE SEAN DODGE, THE PATIENT EXPIRED DUE TO THEIR CONDITI

  Patient problems: Death; No Consequences Or Impact To Patient

  MAUDE report 8148511 ↗