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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 Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/14/2022
Event Type  malfunction  
Event Description
It was reported that biomed stated the arctic sun device was not able to generate flow during testing. A functional check showed that the circulation pump could not maintain inlet pressure at -7psi around a pump speed of less than 63 percent. Mss discussed that this was indicative of a failing circulation pump and the option of replacing it locally or sending it in for 2000 hours service package. Per follow up information received on 05may2022, technical support and biomed stated that there was no patient involvement during reported event. Biomed would sending the device for 2000 hours preventive maintenance service. Per sample evaluation result received on (b)(6) 2022, during decontamination the arctic sun device was primed to fill. It was noted that debris was observed passing through shunts during decontamination. It was also noted that the chiller to outer shell mounting bolt broken off inside nut plate.
Manufacturer Narrative
The investigation is still in progress. Once the investigation is complete a supplemental report will be filed.
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Brand NameARCTIC SUN® 5000
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
juan velez
8195 industrial blvd
covington 30014
MDR Report Key14914709
MDR Text Key295246158
Report Number1018233-2022-05113
Device Sequence Number1
Product Code DWJ
UDI-Device Identifier00801741080142
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
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
Report Date 06/17/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/05/2022
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? Device Returned to Manufacturer
Date Returned to Manufacturer06/08/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/14/2022
Was Device Evaluated by Manufacturer? No
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: 07/05/2022 Patient Sequence Number: 1