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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 Inaccurate Flow Rate (1249); Insufficient Flow or Under Infusion (2182)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
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 there was low flow on the arctic sun device. Therapy was initiated in the emergency room. They transported the patient up to the icu with the pads. The patient was being treated on arctic sun device , but they were getting low flow. They already changed a pad on the right side thinking it was the cause, but flow was still low. Flow rate was 0. 6lpm, inlet pressure was -2. 6psi, circulation pump (cp) was 100%, pump hours were 2434 and system hours were 2868. Ms&s suggested changing back to the emergency room device (dycry511) as flow was good on the initial device. Flow was 1. 5lpm, inlet pressure was -3. 5psi,circulation pump was 100%, pump hours were 1193 and system hours were 1044. Ms&s placed device in manual mode with only the fluid delivery line (fdl) attached. Flow rate was 1. 9lpm, inlet pressure was -6. 8psi, and circulation pump was 50%. They attached pads one at a time. The diagnostic was as follow: right chest (0. 8lpm, -7. 3psi, 31%cp), right thigh (1. 5lpm, -7. 2psi, 49%cp), left chest (1. 6lpm, -7. 1psi, 26%cp), left thigh (1. 4lsp, -4. 1psi, 100%cp). Ms&s asked to replace the left thigh pad with a universal pad or with the thigh pad from the set previously opened. Patient's temperature was originally 32c and was now up to 33c. Target was 35c, water was 40c and flow was 1lpm. Ms&s asked nurse to add a pad to the exposed abdomen, and to the left thigh if not already added.
 
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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 Key10556630
MDR Text Key222089773
Report Number1018233-2020-06079
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 Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/25/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/18/2020
Is this an Adverse Event Report? No
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 Received03/02/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/01/2018
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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