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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 Air Leak (1008); Defective Component (2292); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)
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 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. The device was not returned.
 
Event Description
It was reported that the patient was not cooling. The biomed tried to place the device in manual mode and set water temperature at 20c. The device displayed 'low air leak' message and the manual control box did not appear. Therapy was stopped in order to put the device in manual control at 4c. System diagnostics was reviewed, inlet pressure was -7. 2 psi, the flow rate was 3. 5 l/min, t1 was 28c, t2 was 27. 9c, and t4 was 28c. The biomed said that the low air leak was noted earlier, but not at the time he called. He would call (b)(6) later for further troubleshooting. Biomed (b)(6) spoke to (b)(6). Per (b)(6), (b)(6) stated that the device was not cooling (call transferred to me via ms&s). I had him check t4 temperature and noted it was not dropping below 26 degrees celsius. I had him power the device off and drain the unit. It was observed that no water was coming out of the left drain port. Only the right. I stated that this was indicative of a failed mixing pump and therefore the chiller tank was empty. He stated he had already received the part no. And price from ms&s for the mixing pump.
 
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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
amy gravley
8195 industrial blvd
covington, GA 30014
7707846100
MDR Report Key7453147
MDR Text Key106387318
Report Number1018233-2018-01342
Device Sequence Number1
Product Code DWJ
UDI-Device Identifier00801741080142
UDI-Public(01)00801741080142
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 Biomedical Engineer
Type of Report Initial,Followup
Report Date 05/31/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/23/2018
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
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/30/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/01/2015
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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