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U.S. Department of Health and Human Services

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

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MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN 5000 ARCTIC SUN DEVICE Back to Search Results
Model Number 50000000E
Device Problems Patient-Device Incompatibility (2682); Insufficient Information (3190)
Patient Problems Bacterial Infection (1735); Low Blood Pressure/ Hypotension (1914); Unspecified Infection (1930); Pneumonia (2011); Chills (2191); Shaking/Tremors (2515)
Event Type  Injury  
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 the patient experienced an increase in intracranial pressure that may have been related to the device. Therapy was initiated on (b)(6) 2018. On the same day that therapy was initiated, the patient experienced shivering. Counter-warming measures and medications were administered to combat the shivering. The medication was changed to a propofol and fentanyl drip. The patient experienced low blood pressure and was administered vasopressors. On (b)(6) 2018, the water temperature of the device was below 25 c. The site performed a microbiological culture to assess for infection. Preliminary results of sputum culture indicated presence of gram-negative rods infection (gnrs). The patient was then treated with antibacterial zosyn for suspicious of pneumonia. On (b)(6) 2018, the patient's intracranial pressure was measured in the 20's (normal range is between 7 and 15 mmhg). The patient had been shivering. The patient was treated with an external ventricular device (evd) to relieve the pressure. The evd brought the patient's intracranial pressure down to 0 mmhg. The patient was also administered sedatives, propofol and fentanyl, for shivering. Therapy was completed on the original device.
 
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Brand NameARCTIC SUN 5000
Type of DeviceARCTIC SUN 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
yonic anderson
8195 industrial blvd
covington, GA 30014
7707846100
MDR Report Key7793330
MDR Text Key117467471
Report Number1018233-2018-03622
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 other,study
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/15/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/17/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number50000000E
Device Catalogue Number50000000E
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/26/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/25/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 08/17/2018 Patient Sequence Number: 1
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