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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, TEMPERATURE CABLE BARD ARCTIC SUN TEMPERATURE CABLE

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C.R. BARD, INC. (COVINGTON) -1018233 ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, TEMPERATURE CABLE BARD ARCTIC SUN TEMPERATURE CABLE Back to Search Results
Model Number 50000000E
Device Problems Device Sensing Problem (2917); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cardiac Arrest (1762); Death (1802); Hypoxia (1918); Myocardial Infarction (1969); Pulmonary Edema (2020); Ventricular Tachycardia (2132); No Consequences Or Impact To Patient (2199); Heart Failure (2206); Respiratory Failure (2484); Alteration In Body Temperature (2682)
Event Date 12/09/2018
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 on sunday, (b)(6) 2018, at 11:19 pm, from a call placed to the ms&s helpline by nurse (b)(6) from (b)(6) hospital. Nurse (b)(6) stated the device had two alerts indicating that the patient¿s temperature was erratic. After troubleshooting with ms&s, the nurse was advised to replace the temperature cable. A follow-up call was placed on tuesday, (b)(6) 2018, by an fa specialist who spoke with nurse (b)(6) the clinical coordinator in icu. Nurse (b)(6) stated that the nurse switched the temperature cable and therapy continued with no further issues. However; therapy was not completed because the patient had expired. She also stated that the death was due to the patient¿s condition and not related to the arctic sun device. The patient was a (b)(6) year old male who weighed (b)(6) kg and was admitted to the icu with systolic heart failure, acute respiratory failure, hypoxia, acute pulmonary edema, a non st elevated myocardial infarction, supraventricular tachycardia, metabolic acidosis, and leukocytosis. The patient¿s medical history also included coronary artery disease, diabetes, tobacco use, and multiple cardiac stent placements with a cardiac ejection fraction of 25%. The patient coded on (b)(6) 2018, at 7:07pm, in the icu where he was then intubated. The patient was placed on vasopressin, levophed, neosynephrine, and dopamine. Following the code, the patient¿s neurological assessment showed a glasgow coma scale of 3. At 9:25pm on (b)(6) 2018, the patient was placed on the arctic sun device. The ms&s helpline was called at 11:19 pm on (b)(6) 2018, due to the patient¿s erratic temperature. During the time of the call, the patient¿s temperature was 36. 5c and the water temperature was 5. 7c. The temperature cable was replaced with a new cable as advised by ms&s and therapy continued. The patient reached target temperature per the facility¿s protocol of 32c at 1:13am on (b)(6) 2018. The patient was in the maintenance phase when he coded a second time at approximately 3:30am on (b)(6) 2018. The patient expired at 3:52am on (b)(6) 2018. The nurse stated that the cause of death was cardiac arrest. The facility¿s biomed department was notified by the clinical coordinator to evaluate the temperature cable.
 
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Brand NameARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, TEMPERATURE CABLE BARD
Type of DeviceARCTIC SUN TEMPERATURE CABLE
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
Manufacturer (Section G)
MEDIVANCE, INC. ¿ 1725056
321 s taylor ave
louisville CO 80027
Manufacturer Contact
yonic anderson
8195 industrial blvd
covington, GA 30014
7707846100
MDR Report Key8217660
MDR Text Key133123604
Report Number1018233-2019-00102
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K161602
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/08/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/04/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number50000000E
Device Catalogue Number73503
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/17/2019
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

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