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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 5000-01-05
Device Problem Partial Blockage (1065)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/31/2023
Event Type  malfunction  
Event Description
It was reported that the arctic sun device was giving low flow, error 41 (low internal flow).Per review of wo on 19aug2023, there was no patient involvement.Per follow up review of wo on 01sep2023, the mixing pump assy, circulation pump assy, heater and drain valve will be replaced.All tests performed according to procedure.The equipment has been visually examined and found to be free of physical damage.Low flow caused by considered a failure in the mixing pump, it was identified in the machine that the equipment was not used for a long time.Per sample evaluation results on 29aug2023, it was reported that the drain ports were clogged.Device underwent 2000 preventive maintenance.
 
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11: section a through f - the information provided by bd represents all 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 bd.
 
Event Description
It was reported that the arctic sun device was giving low flow, error 41 (low internal flow).Per review of wo on 19aug2023, there was no patient involvement.Per follow up review of wo on 01sep2023, the mixing pump assy, circulation pump assy, heater and drain valve will be replaced.All tests performed according to procedure.The equipment has been visually examined and found to be free of physical damage.Low flow caused by considered a failure in the mixing pump, it was identified in the machine that the equipment was not used for a long time.Per sample evaluation results on 29aug2023, it was reported that the drain ports were clogged.Device underwent 2000 preventive maintenance.
 
Manufacturer Narrative
Upon further review, bd has determined that this mdr was initially reported in error as this event is not reportable.H11:section a through f - the information provided by bd 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 bd.
 
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Brand Name
ARCTIC SUN® 5000
Type of Device
ARCTIC 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
xeeroy rada
8195 industrial blvd
covington 30014
7707846100
MDR Report Key17729304
MDR Text Key323181847
Report Number1018233-2023-06724
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeBR
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 Physician
Type of Report Initial,Followup
Report Date 11/29/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number5000-01-05
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/31/2023
Initial Date FDA Received09/12/2023
Supplement Dates Manufacturer Received11/30/2023
Supplement Dates FDA Received11/30/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other;
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