BEUDAMED
    FDA Adverse Event Death Summary report: N

    ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, TEMPERATURE CABLE NELLCOR

    MDR report key: 9235169 · Received October 24, 2019

    Report

    Report Number
    1018233-2019-06781
    Event Type
    Death
    Date Received
    October 24, 2019
    Date of Event
    October 1, 2019
    Report Date
    November 27, 2019
    Manufacturer
    MEDIVANCE, INC. ¿ 1725056
    Product Code
    DWJ
    PMA / PMN Number
    K161602
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. A POTENTIAL ROOT CAUSE OF THE REPORTED ISSUE COULD BE A DEFECTIVE TEMPERATURE CABLE. HOWEVER, THIS CANNOT BE CONFIRMED. THE LOT NUMBER IS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: ¿TEMPERATURE PROBE PLACEMENT PATIENT TEMPERATURE CONTROL WITH THE ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM REQUIRES PATIENT TEMPERATURE FEEDBACK PROVIDED BY AN INDWELLING PATIENT TEMPERATURE PROBE CONNECTED TO THE PATIENT TEMPERATURE 1 CONNECTOR ON THE BACK OF THE CONTROL MODULE. ANY COMMERCIALLY-AVAILABLE YELLOW SPRINGS INSTRUMENT 400 SERIES (YSI 400) COMPATIBLE PATIENT TEMPERATURE PROBE CAN BE CONNECTED TO THE ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM. REFER TO THE MANUFACTURER¿S INSTRUCTIONS FOR USE FOR THE SPECIFIC INDICATIONS AND TEMPERATURE PROBE PLACEMENT." THE DEVICE WAS NOT RETURNED.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE LOT NUMBER IS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: ¿TEMPERATURE PROBE PLACEMENT PATIENT TEMPERATURE CONTROL WITH THE ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM REQUIRES PATIENT TEMPERATURE FEEDBACK PROVIDED BY AN INDWELLING PATIENT TEMPERATURE PROBE CONNECTED TO THE PATIENT TEMPERATURE 1 CONNECTOR ON THE BACK OF THE CONTROL MODULE. ANY COMMERCIALLY-AVAILABLE YELLOW SPRINGS INSTRUMENT 400 SERIES (YSI 400) COMPATIBLE PATIENT TEMPERATURE PROBE CAN BE CONNECTED TO THE ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM. REFER TO THE MANUFACTURER¿S INSTRUCTIONS FOR USE FOR THE SPECIFIC INDICATIONS AND TEMPERATURE PROBE PLACEMENT." 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PULMONARY ARTERY CATHETER AND ESOPHAGEAL PROBE WERE NOT CORRELATING IN TEMPERATURE WITH THE BLADDER PROBE CONNECTED TO THE ARCTIC SUN DEVICE. THE ARCTIC SUN TEMPERATURE WAS READING 36.1C WHILE THE OTHER TWO DEVICES WERE READING 34.2C. THE TARGET TEMPERATURE OF THE HYPOTHERMIC PATIENT WAS 36C. MS&S WAS CALLED FOR ASSISTANCE. THE ARCTIC SUN DEVICE HAD A WATER TEMPERATURE OF 7.3C AND FLOW RATE 1.8 L/MIN. DURING TROUBLESHOOTING, THE NURSE CONNECTED THE ESOPHAGEAL PROBE TO THE ARCTIC SUN DEVICE, WHICH GAVE A TEMPERATURE READING OF 34.2C, WHICH WAS THE SAME AS THE PULMONARY ARTERY CATHETER. MS&S INFORMED THE NURSE THAT IT CAN TAKE SEVERAL MINUTES FOR THE BLADDER TEMPERATURE TO CHANGE AFTER THE ESOPHAGEAL TEMPERATURE CHANGES, BUT USUALLY THERE WAS NOT THIS MUCH DISCREPANCY. THE NURSE REPORTED THAT THE BLADDER TEMPERATURE HAD NOT CHANGED IN A LONG TIME. MS&S ADVISED TO LEAVE THE ESOPHAGEAL PROBE CONNECTED TO THE ARCTIC SUN DEVICE AND TO DO A SPOT CHECK OF THE PATIENT¿S TEMPERATURE. MS&S RECOMMENDED THAT THE NURSE CHANGE OUT THE DEVICE IF THE TEMPERATURES CONTINUED TO NOT CORRELATE. DURING A MS&S FOLLOW UP CALL, THE NURSE STATED THAT THE PATIENT EXPIRED, AND THE DEATH WAS NOT DEVICE RELATED. THE CAUSE OF DEATH AND THE PATIENT HISTORY WAS UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PULMONARY ARTERY CATHETER AND ESOPHAGEAL PROBE WERE NOT CORRELATING IN TEMPERATURE WITH THE BLADDER PROBE CONNECTED TO THE ARCTIC SUN DEVICE. THE ARCTIC SUN TEMPERATURE WAS READING 36.1C WHILE THE OTHER TWO DEVICES WERE READING 34.2C. THE TARGET TEMPERATURE OF THE HYPOTHERMIC PATIENT WAS 36C. MS&S WAS CALLED FOR ASSISTANCE. THE ARCTIC SUN DEVICE HAD A WATER TEMPERATURE OF 7.3C AND FLOW RATE 1.8 L/MIN. DURING TROUBLESHOOTING, THE NURSE CONNECTED THE ESOPHAGEAL PROBE TO THE ARCTIC SUN DEVICE, WHICH GAVE A TEMPERATURE READING OF 34.2C, WHICH WAS THE SAME AS THE PULMONARY ARTERY CATHETER. MS&S INFORMED THE NURSE THAT IT CAN TAKE SEVERAL MINUTES FOR THE BLADDER TEMPERATURE TO CHANGE AFTER THE ESOPHAGEAL TEMPERATURE CHANGES, BUT USUALLY THERE WAS NOT THIS MUCH DISCREPANCY. THE NURSE REPORTED THAT THE BLADDER TEMPERATURE HAD NOT CHANGED IN A LONG TIME. MS&S ADVISED TO LEAVE THE ESOPHAGEAL PROBE CONNECTED TO THE ARCTIC SUN DEVICE AND TO DO A SPOT CHECK OF THE PATIENT¿S TEMPERATURE. MS&S RECOMMENDED THAT THE NURSE CHANGE OUT THE DEVICE IF THE TEMPERATURES CONTINUED TO NOT CORRELATE. DURING A MS&S FOLLOW UP CALL, THE NURSE STATED THAT THE PATIENT EXPIRED, AND THE DEATH WAS NOT DEVICE RELATED. THE CAUSE OF DEATH AND THE PATIENT HISTORY WAS UNKNOWN.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PULMONARY ARTERY CATHETER AND ESOPHAGEAL PROBE WERE NOT CORRELATING IN TEMPERATURE WITH THE BLADDER PROBE CONNECTED TO THE ARCTIC SUN DEVICE. THE ARCTIC SUN TEMPERATURE WAS READING 36.1C WHILE THE OTHER TWO DEVICES WERE READING 34.2C. THE TARGET TEMPERATURE OF THE HYPOTHERMIC PATIENT WAS 36C. MS&S WAS CALLED FOR ASSISTANCE. THE ARCTIC SUN DEVICE HAD A WATER TEMPERATURE OF 7.3C AND FLOW RATE 1.8 L/MIN. DURING TROUBLESHOOTING, THE NURSE CONNECTED THE ESOPHAGEAL PROBE TO THE ARCTIC SUN DEVICE, WHICH GAVE A TEMPERATURE READING OF 34.2C, WHICH WAS THE SAME AS THE PULMONARY ARTERY CATHETER. MS&S INFORMED THE NURSE THAT IT CAN TAKE SEVERAL MINUTES FOR THE BLADDER TEMPERATURE TO CHANGE AFTER THE ESOPHAGEAL TEMPERATURE CHANGES, BUT USUALLY THERE WAS NOT THIS MUCH DISCREPANCY. THE NURSE REPORTED THAT THE BLADDER TEMPERATURE HAD NOT CHANGED IN A LONG TIME. MS&S ADVISED TO LEAVE THE ESOPHAGEAL PROBE CONNECTED TO THE ARCTIC SUN DEVICE AND TO DO A SPOT CHECK OF THE PATIENT¿S TEMPERATURE. MS&S RECOMMENDED THAT THE NURSE CHANGE OUT THE DEVICE IF THE TEMPERATURES CONTINUED TO NOT CORRELATE. DURING A MS&S FOLLOW UP CALL, THE NURSE STATED THAT THE PATIENT EXPIRED, AND THE DEATH WAS NOT DEVICE RELATED. THE CAUSE OF DEATH AND THE PATIENT HISTORY WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1030707 ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, TEMPERATURE CABLE NELLCOR ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM CABLE DWJ MEDIVANCE, INC. ¿ 1725056 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death