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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 Short Fill (1575); No Flow (2991); Suction Failure (4039)
Patient Problem 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.
 
Event Description
It was reported that there was no flow.The biomed stated the device was sent off to repair the circulation pump.He received it back and was trying to fill the device, however it would not fill.He checked the fill tube filter and tried another fill tube.The device still would not fill.With nothing attached to the fluid delivery line and device running, ms&s had the biomed remove the fluid delivery line and check for suction over the left port.He reported that no suction was felt.Ms&s explained that there may be a problem with the circulation pump.Per follow up the biomed stated the machine was still not working and was instructed to send the device in to get repaired.
 
Event Description
It was reported that there was no flow.The biomed stated the device was sent off to repair the circulation pump.He received it back and was trying to fill the device, however it would not fill.He checked the fill tube filter and tried another fill tube.The device still would not fill.With nothing attached to the fluid delivery line and device running, ms&s had the biomed remove the fluid delivery line and check for suction over the left port.He reported that no suction was felt.Ms&s explained that there may be a problem with the circulation pump.Per follow up the biomed stated the machine was still not working and was instructed to send the device in to get repaired.
 
Manufacturer Narrative
Upon further review, bd has determined that this event has previously been captured, therefore, the parent record will be closed.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
louisville CO 80027
MDR Report Key9634460
MDR Text Key183786167
Report Number1018233-2020-00547
Device Sequence Number1
Product Code DWJ
UDI-Device Identifier00801741080142
UDI-Public(01)00801741080142
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
Type of Report Initial,Followup
Report Date 02/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/27/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number50000000
Device Catalogue Number50000000
Was Device Available for Evaluation? Yes
Date Manufacturer Received02/26/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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