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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
Catalog Number 5000-01-01
Device Problems Insufficient Cooling (1130); Failure to Pump (1502)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/28/2021
Event Type  malfunction  
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.
 
Event Description
It was reported that the arctic sun device had zero flow rate. The reported issue was confirmed that it had happened due to a faulty circulation pump and was replaced. Other observations not related to the issue that it had cooling problem due to mixing pump. Per follow up received via ibc on (b)(6) 2021, the device would not be sent to bd-approved facility for evaluation and circulation pump was replaced.
 
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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 Key13314167
MDR Text Key284174682
Report Number1018233-2022-00149
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeKS
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 03/04/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/21/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number5000-01-01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/28/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/04/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/01/2015
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: 01/21/2022 Patient Sequence Number: 1
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