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

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.

• Brand Name: ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, TEMPERATURE CABLE BARD
• Type of Device: ARCTIC 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 Key: 8217660
• MDR Text Key: 133123604
• Report Number: 1018233-2019-00102
• 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: 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 Received: 01/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 50000000E
• Device Catalogue Number: 73503
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/17/2019
• 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