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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 Problem Inaccurate Flow Rate (1249)
Patient Problems Septic Shock (2068); No Code Available (3191); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 11/30/2020
Event Type  Injury  
Manufacturer Narrative
The investigation is still in progress. Once the investigation is complete a supplemental report will be filed.
 
Event Description
It was reported that the nurse was concerned since the device received an alert 02 (low flow) in the arctic sun device. The patient temperature was 38. 2 c, water temperature was 6. 8 c, and flow rate was 1. 5 l/min. The system diagnostics showed the flow rate was 1. 6 l/min, inlet pressure was -7. 1 psi and the circulation pump was 50% with pads attached. Ms&s suggested the nurse to disconnect, straighten the tubing and reconnect the holding behind the clear clamps. The flow rate stabilized at 1. 7 l/min. After checking with the event log, there was one alert 02 (low flow), one alert 50 (patient temperature 1 erratic), one alarm 15 (unable to obtain a stable patient temperature), and alarm 14 (patient temperature probe 1 out on the range). Ms&s explained that these alerts (or) alarms were typically related to a faulty temperature probe or cable. Ms&s recommended changing the cable first and if the issue returned, then advised to change the foley probe. The nurse stated the patient was in septic shock, no obvious signs of shivering. The patient was mildly sedated. Ms&s discussed the counter warming. Per follow up with customer on (b)(6) 2020, the patient administered nimbex for micro movements. The patient continuing the therapy and no further issues noted. The user denied any probe or cable changes, and noted the device worked without alarms.
 
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Brand NameARCTIC SUN 5000
Type of DeviceARCTIC SUN DEVICE
Manufacturer (Section D)
MEDIVANCE, INC. ¿ 1725056
321 s taylor ave
suite 200
louisville 80027
Manufacturer (Section G)
MEDIVANCE, INC. ¿ 1725056
321 s taylor ave
suite 200
louisville 80027
Manufacturer Contact
yonic anderson
8195 industrial blvd
covington 30014
7707846100
MDR Report Key11031660
MDR Text Key222288260
Report Number1018233-2020-21774
Device Sequence Number1
Product Code DWJ
UDI-Device Identifier00801741127755
UDI-Public(01)00801741127755
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
Report Date 06/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/17/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number50000000E
Device Catalogue Number50000000E
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/24/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/01/2016
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: 12/17/2020 Patient Sequence Number: 1
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