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

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.

• Brand Name: ARCTIC SUN 5000
• Type of Device: ARCTIC 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 Key: 7793330
• MDR Text Key: 117467471
• Report Number: 1018233-2018-03622
• 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: 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 Received: 08/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: 50000000E
• Device Catalogue Number: 50000000E
• 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: 09/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2016
• 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