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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN 5000 ARCTICSUN DEVICE

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MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN 5000 ARCTICSUN DEVICE Back to Search Results
Model Number 50000000
Device Problems Break (1069); Defective Component (2292); Device Displays Incorrect Message (2591)
Patient Problems Death (1802); No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The investigation is still in progress. Once the investigation is complete a supplemental report will be filed. The information provided by bard 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 bard. The device was not returned.
 
Event Description
It was reported that an arctic sun device, with sn (b)(4), was giving an alert 113 during therapy. An (b)(6) year old, male, post cardiac arrest, patient was started on arctic sun therapy on (b)(6) 2018 around 1:00 a. M. The patient¿s temperature was 36c, the target temperature was 33c, and the water temperature was 31c. The nurse called the ms&s helpline on (b)(6) 2018 at 4:22 a. M. To assist with troubleshooting. Ms&s advised that the device be sent to the facility¿s biomed labeled alert 113 with a broken cooler. It was later reported during a follow up call on (b)(6) 2018, the patient was placed on a second arctic sun device with sn (b)(4) and therapy continued with no further issues. The patient was able to reach their target temperature while on the second device on (b)(6) 2018 at 5:00 a. M. The first device with sn (b)(4) was sent to the facility¿s biomed for evaluation. On (b)(6) 2018 at 9:00 a. M. , the family decided to withdraw care, including the device, and place the patient in a dnr status. The patient later expired at 9:47 a. M. On (b)(6) 2018. The nurse reported that the patient expired unrelated to the device and that the cause of death was cardiac related as the patient had a history of cardiac amyloidosis. It was later reported by the nurse, that the patient was on multiple vasopressors including epinephrine, levophed, and vasopressin. The biomed stated that after she finished calibrating the device, she received an error 80. The device was not returned to service and remained in biomed. Per troubleshooting with tech support, they notated that the mixing pump needed to be replaced.
 
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Brand NameARCTIC SUN 5000
Type of DeviceARCTICSUN DEVICE
Manufacturer (Section D)
MEDIVANCE, INC. ¿ 1725056
321 s taylor ave
louisville CO 80027
Manufacturer (Section G)
MEDIVANCE, INC. ¿ 1725056
321 s taylor ave
louisville CO 80027
Manufacturer Contact
amy gravley
8195 industrial blvd
covington, GA 30014
7707846100
MDR Report Key7510584
MDR Text Key108494874
Report Number1018233-2018-01677
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,use
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 06/28/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/14/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number50000000
Device Catalogue Number50000000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/18/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/21/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/21/2013
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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