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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 50000000
Device Problems Insufficient Cooling (1130); Failure to Pump (1502)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/29/2021
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 the arctic sun device was not cooling. The user stated that they observed chiller temperature was below 10c. Mss stated that this was an indication of mixing pump failure. The user stated that they would order and repair it onsite. Per email response received on 04jan2022, the technician asked the biomed if the chiller was reaching the desired 6 degrees celsius after the device had been started and sat undisturbed for ten minutes. Biomed had already done these steps previously and explained the chiller reached the required temperature. The tech explained that the mixing pump was the only part that could be responsible. Biomed also states that the device was on use on patient without any impact and therapy was completed using a different device. The device would be repaired onsite waiting on parts.
 
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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 Key13286674
MDR Text Key284996823
Report Number1018233-2022-00074
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,Health Professional,User Facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/12/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/18/2022
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? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/12/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/31/2015
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: 01/18/2022 Patient Sequence Number: 1
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