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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 Failure to Pump (1502); Insufficient Flow or Under Infusion (2182); Obstruction of Flow (2423)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The investigation is still in progress. Once the investigation is complete a supplemental report will be filed. The device was not returned.
 
Event Description
It was reported that the water flow going through the pads dropped to 0. 5l/min and below. User disconnected and reconnected again, moved the pads, changed the pads, but it did not work. It had a good flow (around 1. 7l/min) but it was suddenly dropping without touching anything. After trying different ports on the fluid delivery line, user changed the arctic sun and it worked perfectly. User checked the machine and needed a calibration. User would contact the technical service to review it. Per additional information, it showed that the device needed a maintenance check, so the advanced maintenance was done and some pieces changed. The deposit showed signs of biofilm. The deposit was cleaned thoroughly. Therapy discontinued because of the issue.
 
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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 Key10379409
MDR Text Key203151688
Report Number1018233-2020-05033
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
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 02/17/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/07/2020
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 Manufacturer07/20/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/27/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/01/2017
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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